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Item 1. Business

2025-02-27 compared with 2024-02-26 · 541 added, 774 removed, 863 unchanged (60% of the section changed)

We are a global oncology company discovering and developing innovative treatments that are more accessible and affordable to cancer patients worldwide.

We generated global revenue of approximately $2.5 billion in 2023, which increased by approximately $1.0 billion, while reducing our net loss by approximately $1.1 billion in comparison to 2022.

We currently have three approved medicines that were internally discovered and developed, including BRUKINSA ® (zanubrutinib), a small molecule inhibitor of Bruton’s Tyrosine Kinase (“BTK”) for the treatment of various blood cancers;

TEVIMBRA ® (tislelizumab), an anti-PD-1 antibody immunotherapy for the treatment of various solid tumor and blood cancers;

and PARTRUVIX ® (pamiparib), a selective small molecule inhibitor of PARP1 and PARP2.

We have obtained approvals to market BRUKINSA in the United States (“U.S.”), the People’s Republic of China (“China” or the “PRC”), the European Union (“EU”), the United Kingdom (“UK”), Canada, Australia, and additional international markets;

TEVIMBRA (tislelizumab) in the EU and China;

and PARTRUVIX in China.

By leveraging our strong commercial capabilities, we have in-licensed the rights to distribute an additional 14 approved medicines for the China market.

Supported by our global clinical development and commercial capabilities, we have entered into collaborations with world-leading biopharmaceutical companies such as Amgen Inc.

(“Amgen”) and Beijing Novartis Pharma Co., Ltd.

(“Novartis”) to develop and commercialize innovative medicines.

We are committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe.

Recognizing the importance of clinical trial activities in our industry and the challenges associated with outsourcing to third-party contract research organizations (“CROs”), we have built our own 3,000+ person internal clinical team and are largely CRO-free.

We have conducted more than 130 clinical trials in-house, with over 22,000 subjects enrolled in approximately 45 regions.

This includes more than 40 pivotal or potentially registration-enabling trials across our portfolio.

We have built, and are expanding, our internal manufacturing capabilities.

We are building a commercial-stage biologics manufacturing and clinical R&D center at the Princeton West Innovation Park in Hopewell, New Jersey (the “Hopewell facility”), in addition to our existing state-of-the-art biologic and small molecule manufacturing facilities in China to support current and potential future demands of our medicines.

We also work with high quality contract manufacturing organizations (“CMOs”) to manufacture our internally developed clinical and commercial products.

Since our inception in 2010, we have become a fully integrated global organization of over 10,000 employees worldwide, primarily in the U.S., China, and Europe.

We are a leading global oncology company discovering and developing innovative treatments that are more accessible and affordable to cancer patients worldwide.

In 2024, we generated total global revenue of approximately $3.8 billion, increasing revenue by approximately $1.4 billion from the prior year, while reducing our operating loss from the prior year by approximately $0.6 billion.

We are serial innovators in hematology and have built a differentiated, wholly-owned, franchise.

This includes a proven best-in-class Bruton’s Tyrosine Kinase inhibitor (“BTKi”), BRUKINSA ® , and two late-stage assets, sonrotoclax (“BCL2i”) and our first-in-class BTK-CDAC, both of which have the potential to be best-in-class medicines.

BRUKINSA was designed for complete sustainable inhibition of BTK with the belief that this would improve patient outcomes.

This hypothesis was supported in the ALPINE trial, where BRUKINSA demonstrated sustained superior efficacy and lower cardiac toxicity in an all-comers relapsed/refractory (“R/R”) chronic lymphocytic leukemia (“CLL”) population against ibrutinib.

BRUKINSA is the only BTKi to prove superior efficacy to ibrutinib.

BRUKINSA has the broadest label in the class, with U.S.

approvals in CLL, mantle cell lymphoma (“MCL”), Waldenström’s macroglobulinemia (“WM”), marginal zone lymphoma (“MZL”) and follicular lymphoma (“FL”).

In less than two years from its first approval in CLL, and despite being the third entrant to the market, BRUKINSA has become the leader in new patients starts in the U.S., in both frontline and R/R CLL, as well as all other approved indications.

BRUKINSA generated $2.6 billion in sales in 2024, is approved in over 70 markets and remains in the early stage of its launch in many key markets, including Europe, Japan, Korea and Brazil.

Sonrotoclax, our BCL2 inhibitor, is a selective BCL2i designed to have greater potency and selectivity, and potential for better tolerability than venetoclax.

Our clinical program for sonrotoclax has enrolled over 1,800 patients to date.

It is being tested in late-stage clinical trials with BRUKINSA, including as a fixed duration therapy in the Phase 3 CELESTIAL trial of BRUKINSA + sonrotoclax in 1L CLL, which is fully enrolled.

Our BTK-CDAC, which is designed to promote the degradation, of both wildtype and mutant forms of BTK, including those that commonly result in resistance to BTK inhibitors in patients who experience progressive disease, has enrolled over 500 patients and is the most advanced BTK degrader in the clinic.

Data presented at the American Society of Hematology (“ASH”) meeting in 2024 showed significant early efficacy signals and safety data in a heavily pretreated population.

We plan to initiate a Phase 3 head-to-head trial in 2025 against pirtobrutinib, consistent with our strategy to develop medicines that have potential to meaningfully improve upon the current practice of care.

With these three differentiated and synergistic assets, we believe we are uniquely positioned to provide the best solution for all CLL patients along their treatment journey and build a sustainable franchise in the $12 billion global CLL market.

We are a company built to address the long-lived challenges to return on investment in the pharmaceutical industry.

Clinical trials represent more than 75% of the total cost of bringing an oncology medicine to patients, yet the industry continues to outsource this function to contract research organizations (“CROs”) at an ever-increasing cost per patient.

Regulatory policies such as Project Optimus, while well intended, lead to meaningful program delays and increasing Phase 1 trial costs due to increased patient requirements and time.

Increased competition exists for nearly every validated target, and pricing reform, such as the Inflation Reduction Act (“IRA”) in the U.S., is placing direct and indirect pressure on innovators.

Since inception, we have focused on building unique and hard to replicate competitive advantages that address these industry-wide challenges.

Most importantly, our internal clinical team of approximately 3,700 colleagues across the globe allows us to break from the traditional CRO model and develop medicines with greater speed and at a lower cost than many of our industry peers while maintaining quality.

This capability paired with our internal research and manufacturing capabilities enables a “fast to proof-of-concept” (“PoC”) approach that can reduce time in early-stage development.

We are innovating with intentionality and building best in class combinations to win in the increasingly competitive commercial landscape.

We have a deep and innovative solid tumor pipeline.

In 2024 alone, we advanced 13 differentiated new molecular entities (“NMEs”) into the clinic, each of which have the potential to be first-in-class or best-in-class.

Our intention is to build depth in the most prevalent cancers, including breast/gynecologic, lung and gastrointestinal.

We have main PoC catalysts in the next six to eighteen months for key programs, including, our next-generation CDK4 inhibitor and potentially first-in-class B7H4 antibody-drug conjugate (“ADC”) in breast/gynecologic cancers, potential best-in-class pan-KRAS inhibitor in gastrointestinal (“GI”) cancer, differentiated mechanism of action (“MoA”) and first-in-class EGFR-CDAC in lung cancer, as well as our synergistic and potentially best-in-class PRMT5 and MAT2A inhibitors combination in lung cancer.

We also have several exciting early stage assets, including CDK2i, B7H3 ADC, CEA-ADC, FGFR2b ADC, EGFRxMET TsAb, and IRAK4 CDAC.

Since our inception in 2010, we have become a fully integrated global organization with more than 11,000 employees worldwide.

Our Holding Company Structure

We are a holding company incorporated in the Cayman Islands with operations primarily conducted through our subsidiaries in the U.S., China, UK, Switzerland, and Australia.

We are a holding company currently incorporated in the Cayman Islands with operations primarily conducted through our subsidiaries in the U.S., China, the UK, Switzerland, and Australia.

The following diagram depicts a summary of our corporate structure.

Our corporate structure contains no variable interest entities.

In 2024, we announced plans to redomicile our holding company to Switzerland in 2025.

We were founded with the vision to create an integrated biopharmaceutical company to address challenges in the pharmaceutical industry, creating impactful medicines that will be affordable and accessible to far more patients around the world.

We have made significant progress towards accomplishing this vision over our first 13 years and have five strategic competitive advantages positioning us for success both near- and long-term:

We have built a substantial global development and medical affairs team of 3,000+ people on five continents, allowing us to run clinical trials predominantly without reliance on CROs.

Clinical development accounts for over 75% of the cost and most of the time to develop a medicine.

We believe that by fully integrating these capabilities, we can create a strategic competitive advantage.

By retaining clinical development activities internally, we can decrease the costs of our trials, increase enrollment speed, and leverage technology to ensure quality and consistency across trials and clinical sites.

It also allows us to become more inclusive in the location and number of clinical sites to help improve the diversity of patients in our trials.

Our demonstrated ability to complete large-scale, multi-regional clinical trials is one of our most important strategic competitive advantages and addresses an immense challenge in the pharmaceutical industry.

We have built one of the world’s largest, most productive and cost-effective oncology research teams with 1,100+ scientists.

Their efforts have been validated by commercial approvals, clinical data, and collaborations that have secured $1.5 billion in collaboration payments to the company.

We have successfully developed three commercially approved medicines from our internal discovery engine, including BRUKINSA and TEVIMBRA.

We design each research program with a differentiated biological hypothesis or a first-in-class mechanism of action.

Our lead medicine, BRUKINSA, has demonstrated superiority for both progression-free survival and overall response rate versus ibrutinib in relapsed or refractory (“R/R”) chronic lymphocytic leukemia (“CLL”).

Our broad pipeline also includes internally developed products with the potential to be best-in-class or first-in-class, including sonrotoclax (our BCL-2 inhibitor) and BGB-16673 (a BTK-targeted CDAC) that have both demonstrated their potential with early data.

Our pipeline also includes many early-stage assets for targets including, pan-KRAS, PRMT5, CDK4, CDK2, B7H3 ADC, CEA-ADC, B7H4-ADC, MUC1 x CD16A bispecific antibody (“BsAb”), and Claudin6 x CD3 BsAb.

We have invested in technology platforms, including CDAC protein degraders, bispecific antibodies, tri-specific antibodies, ADCs, cell therapies, and mRNA.

Our research and innovation capabilities will ensure we discover high-quality and impactful medicines for patients.

We have built a strong commercial portfolio, centered around two foundational medicines, BRUKINSA and TEVIMBRA, that are primary revenue sources and support the development of our future pipeline and additional combination therapies.

Our hematological franchise is led by BRUKINSA, which is supported by a broad clinical program with over 5,000 patients in 37 trials in 29 markets.

We ran two extensive head-to-head studies versus ibrutinib with over 800 patients enrolled.

We are the first and only BTK inhibitor to demonstrate superior efficacy versus ibrutinib, and the data from the head-to-head ALPINE trial were selected for the prestigious late-breaker session at the American Society of Hematology (“ASH”) meeting in late 2022, with simultaneous publication in The New England Journal of Medicine .

Based on the pooled safety data generated from our trials, we have shown a very favorable safety profile, especially when compared to ibrutinib in cardiovascular safety, including atrial fibrillation, ventricle arrhythmia, and hypertension.

In December 2023, the U.S.

Food and Drug Administration (“FDA”) approved a label update for BRUKINSA to include superior progression-free survival (“PFS”) results from the Phase 3 ALPINE trial comparing BRUKINSA against IMBRUVICA in previously treated patients with R/R CLL.

We believe the differentiation of BRUKINSA has been recognized by the market and global BRUKINSA sales increased 128.5% in 2023 vs.

BRUKINSA allows us to build a strong position in heme-oncology and we plan to solidify our leadership in CLL with sonrotoclax (BCL2i) and our BTK-CDAC while amplifying our impact in other B-cell malignancies with progressive treatment strategies such as fixed duration and rational sequencing.

Our solid tumor franchise is led by our anti-PD-1 monoclonal antibody, TEVIMBRA, which is currently approved in China in twelve indications and has achieved the commercial market leader position in China in the PD-1/PDL-1 class.

Outside of China, TEVIMBRA has been approved in Europe and South Korea and we anticipate U.S.

approval on or before July 2024 for first-line ESCC.

With TEVIMBRA and the potentially best-in-class or first-in-class pipeline assets targeting pan-KRAS, PRMT5, CDK4, CDK2, B7H3 ADC, CEA-ADC, B7H4-ADC, MUC1 x CD16A BsAb, and Claudin6 x CD3 BsAb, we are well-positioned to build our solid tumor business and deliver innovative therapies and combinations to patients.

We have a differentiated global commercial organization of over 3,700 people to deliver medicines to patients around the globe, including over 500 in North America and Europe.

In North America, our team continues to grow BRUKINSA sales following the approvals in the U.S.

and Canada for CLL and small lymphocytic lymphoma (“SLL”) indications in 2023.

In China, the commercial team is marketing 17 internally developed and licensed medicines across solid tumors and hematology.

BRUKINSA and TEVIMBRA continue to strengthen market leadership positions in China in the BTKi and PD-1/PDL-1 classes, respectively.

Altogether, BRUKINSA has been approved in more than 65 markets, with additional filings pending or planned.

We reacquired the global rights of TEVIMBRA from Novartis in 2023 upon bilateral agreement.

TEVIMBRA received approval from EMA and South Korea and additional approvals and filings are pending or planned.

Our strategy is to commercialize our medicines broadly throughout the world.

Our commercial capabilities have expanded into the Asia Pacific, Latin America and Middle East regions through our affiliates or distribution partners.

We have built a global commercial organization that will drive the delivery of highly effective and differentiated medicines to patients around the globe and will continue to collaborate with business partners to bridge health inequities.

We have financial strength .

In a time when the cost of capital has risen, we are well positioned financially.

We had cash and cash equivalents of $3.2 billion as of December 31, 2023.

We already have substantial product revenue of $2.2 billion including from our cornerstone assets, which we expect to continue to grow significantly in 2024 and beyond.

We expect product revenue growth to outpace our operating expense growth, which will allow us to continue to improve our operating leverage and cash flow.

We will continue to be thoughtful and strategic in how we deploy our capital, and we are committed to generating long-term value for our shareholders.

We are uniquely built to address an increasingly challenged industry and improve R&D returns.

We have built a substantial global clinical team of approximately 3,700 people on six continents, allowing us to run clinical trials predominantly without reliance on CROs.

We believe independence from traditional CRO models allows us to execute more cost-efficient development and achieve faster time to clinical proof-of-concept.

It also allows us to expand the reach of our clinical sites, which supports diverse participation and the collection of robust data across all patient demographics.

Our demonstrated ability to complete large-scale, multi-regional clinical trials is an important strategic competitive advantage and addresses an immense challenge in the pharmaceutical industry.

We have built a highly productive and cost-effective oncology research teams with 1,100+ scientists, allowing us to drive serial innovation to enable sustained market leadership .

Our efforts have been validated by commercial approvals, clinical data, and collaborations that have secured $1.5 billion in collaboration payments to our company.

We design each research program with a differentiated biological hypothesis MoA, which has resulted in multiple commercially approved medicines and a pipeline of wholly-owned assets with potential for combinations and depth in key tumor types.

We have invested in diverse technology platforms to pursue innovation, including CDAC protein degraders, bispecific antibodies, tri-specific antibodies, and ADCs allowing us access to diverse modalities and to advance science with urgency and agility.

Our CDAC platform, in particular, offers a differentiated approach from small molecules with its catalytic activity, higher barrier to resistance, and scaffold function disruption, and we believe it has the potential to emerge as a best-in-class approach.

Our research and innovation capabilities are primed for discovering high-quality and impactful medicines for patients in a highly productive and cost-effective way.

We have built a strong commercial portfolio, with BRUKINSA and TEVIMBRA ® driving global revenue.

Solidifying our Sustainable Hematology Franchise

Our hematology franchise is led by BRUKINSA, which is supported by a broad clinical program with over 7,100 patients enrolled in more than 30 countries and regions across more than 35 trials.

We continue to solidify our leadership in hematology, utilizing BRUKINSA as our cornerstone asset.

We are focused on lifecycle management to build a sustainable hematology franchise maximizing value for our company, shareholders and patients globally.

BRUKINSA has allowed us to build a strong franchise in hematology-oncology and we plan to solidify our leadership in CLL with our wholly-owned, emerging best-in-class hematology pipeline consisting of sonrotoclax and our BTK-CDAC, while amplifying our impact in other B-cell malignancies.

We believe our BTK-CDAC combinations with BRUKINSA and sonrotoclax show promise to meaningfully outperform fixed duration regimens in CLL, and our three differentiated molecules offer potential best-in-disease combinations to cover the entire CLL patient spectrum and insulate BeiGene from end-of-lifecycle pricing pressure.

Expanding Access to Our PD-1 Inhibitor for Patients Worldwide and Building Global Commercial Capabilities to Support Prolific Pipeline

Our solid tumor franchise is led by our anti-PD-1 monoclonal antibody, TEVIMBRA ® , which is currently approved in the U.S., EU, China and other countries.

We intend to expand TEVIMBRA’s global footprint through ongoing submissions and approvals.

We are also developing a high-concentration subcutaneous formulation of TEVIMBRA which we believe will be competitive in global markets.

With TEVIMBRA and the potentially best-in-class solid tumor pipeline assets, we are well-positioned to build our solid tumor business and deliver innovative therapies and combinations to patients.

We have a global commercial organization to deliver medicines to patients around the globe .

We have established commercial capabilities in key large commercial markets of the U.S., E.U and China, and continue our rapid expansion of capabilities into Asia Pacific, Latin America, and Middle East regions, driving the delivery of highly effective and differentiated medicines to patients around the globe.

This has enabled a geographically diversified revenue mix and a truly global business.

Our business model is sustainable and results in strong global financial profile.

We believe we are financially well-positioned with cash and cash equivalents of $2.6 billion as of December 31, 2024.

Our product revenue has grown 73% since 2023 from our current portfolio and cornerstone assets, which we expect to grow significantly in 2025 and beyond.

We significantly reduced our GAAP operating losses and achieved non-GAAP operating income for the first time for fiscal year 2024.

We generated positive cash flows from operations for the first time in both the third and fourth quarters of 2024 after years of using cash in our operations.

We will continue to be thoughtful and strategic in how we deploy our capital, and consistent with previous collaborations, we will actively explore partnerships that strengthen our business.

We are committed to generating long-term value for our shareholders.

Our Commercial and Registration Stage Products

The following table summarizes the status of our commercial products as of February 27, 2025:

PRODUCT LEAD INDICATIONS MECHANISM OF ACTION REGULATORY STATUS BEIGENE COMMERCIAL RIGHTS PARTNER

CLL/SLL, R/R MCL 1 , WM & R/R MZL 1 ;

R/R MCL 2 , R/R CLL/SLL, TN CLL/SLL, R/R WM & TN WM;

WM, R/R MZL, R/R CLL/SLL, R/R FL

BTK inhibitor Approved in more than 65 markets, incl.

U.S., China, EU, and other markets Global N/A

1L squamous and non-squamous NSCLC/ 2/3 L NSCLC/ R/R classical hodgkin’s lymphoma2 / 2/3 L HCC2/ R/R PD-L1+ UC2, MSI-H or dMMR solid tumors, 2L ESCC, 1L NPC, 1L GC/GEJC, 1L ESCC, 1L HCC;

2L ESCC Anti-PD-1 antibody Approved in China, EU 4 , and 3 other markets;

BLA accepted in U.S.

3L BRCA-mutated ovarian cancer 2

PARP inhibitor Approved in China Global N/A

Giant cell tumor of bone / Skeletal related events (SREs) 8

Anti-RANK ligand antibody Approved in China Mainland China

R/R acute lymphocytic leukemia Anti-CD19 x anti-CD3 bispecific T-cell engager (BiTE) Approved in China Mainland China

R/R multiple myeloma 8

Proteasome inhibitor Approved in China Mainland China

R/R adult multiple myeloma, newly diagnosed multiple myeloma, previously treated follicular lymphoma Anti-angiogenesis, immuno-modulation Approved in China Mainland China 9

Myelodysplastic syndromes, acute myeloid leukemia, chronic myelomonocytic leukemia DNA hypomethylation Approved in China Mainland China 9

Idiopathic multicentric Castleman disease IL-6 antagonist Approved in China Greater China

High-risk neuroblastoma 2

Anti-GD2 antibody Approved in China Mainland China

PRODUCT MECHANISM OF ACTION REGULATORY STATUS BEIGENE COMMERCIAL RIGHTS PARTNER

BRUKINSA BTK inhibitor Approved in 73 markets, incl.

U.S., China, EU, Japan, and other markets Global N/A

TEVIMBRA Anti-PD-1 antibody Approved in 45 markets, incl.

U.S., EU, China, and other markets Global N/A

PARTRUVIX PARP inhibitor Approved in China Global N/A

XGEVA Anti-RANK ligand antibody Approved in China Mainland China Amgen

BLINCYTO Anti-CD19 x anti-CD3 bispecific T-cell engager (BiTE) Approved in China Mainland China Amgen

KYPROLIS Proteasome inhibitor Approved in China Mainland China Amgen

SYLVANT IL-6 antagonist Approved in China Greater China EUSA Pharma

QARZIBA Anti-GD2 antibody Approved in China Mainland China EUSA Pharma

POBEVCY ® (Avastin biosimilar)

Colorectal, lung, glioblastoma, ovarian, fallopian tube or primary peritoneal, and cervical cancers Anti-VEGF antibody Approved in China Greater China

Anti-VEGF antibody Approved in China Greater China Bio-Thera

BAITUOWEI ® (goserelin microspheres for injection)

Breast and prostate cancers Gonadotropin-releasing hormone (GnRH) agonist Approved in China Mainland China

Gonadotropin-releasing hormone (GnRH) agonist Approved in China Mainland China Luye Pharma

TAFINLAR ® (dabrafenib)

NSCLC 5 , melanoma

BRAF inhibitor Approved in China China Broad Markets 1

MEKINIST ® (trametinib)

NSCLC 5 , melanoma

MEK inhibitor Approved in China China Broad Markets 1

VOTRIENT ® (pazopanib)

Advance renal cell carcinoma VEGFR inhibitor Approved in China China Broad Markets 7

VEGFR inhibitor Approved in China China Broad Markets 1

AFINITOR ® (everolimus)

Advanced renal cell carcinoma 6 , NET, SEGA & breast cancers

mTOR inhibitor Approved in China China Broad Markets 1

ZYKADIA ® (ceritinib)

ALK + NSCLC ALK inhibitor Approved in China China Broad Markets 7

Approved under accelerated approval.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Conditionally approved.

Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

The approval is applicable to all 27 EU member states, plus Iceland, Lichtenstein and Norway.

For patients with unresectable recurrent locally advanced or metastatic ESCC after prior systemic therapy, and as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC.

Accepted for review for patients with NSCLC including:

locally advanced or metastatic NSCLC after prior chemo, in combination with chemotherapy for 1L advanced or metastatic squamous NSCLC, and in combination with chemotherapy for 1L locally advanced or metastatic non-squamous NSCLC with no EGFR or ALK positive mutations.

TAFINLAR, in combination with MEKINIST, is indicated for the treatment of patients with metastatic NSCLC with BRAF V600E mutation as detected by an FDA-approved test.

Following progression on or after vascular endothelial growth factor (VEGF)-targeted therapy.

ALK inhibitor Approved in China China Broad Markets 1

Rights to promote and market in China’s broad markets pursuant to a Market Development Agreement with an affiliate of Novartis Pharma AG.

Conditionally approved.

Full approval of any particular indication will depend on the results of required post-marketing study(ies) in China.

As part of the settlement agreement with BMS, the license and supply agreement covering REVLIMID and VIDAZA was terminated as of December 31, 2023, subject to our right to continuing selling inventory until it is sold out or December 31, 2024.

Abbreviations:

ALK = anaplastic lymphoma kinase;

BLA = Biologics License Application;

BRAF = B-rapidly accelerated fibrosarcoma;

CLL = chronic lymphocytic leukemia;

EGFR = epidermal growth factor receptor;

ESCC = esophageal squamous cell carcinoma;

GC = gastric cancer;

GEJC = gastroesophageal junction cancer;

HCC = hepatocellular carcinoma;

MAA = marketing authorization application;

MCL = mantle cell lymphoma;

MEK = mitogen-activated protein kinase (MAPK) / Extracellular-signal regulated kinase (ERK);

mTOR = Mammalian target of rapamycin;

MZL = marginal zone lymphoma;

NET= neuroendocrine tumor;

NPC = nasopharyngeal cancer;

NSCLC = non-small cell lung cancer;

R/R = relapsed / refractory;

SEGA= subpendymal giant cell astrocytoma;

SLL = small lymphocytic lymphoma;

UC = urothelial carcinoma;

VEGFR = vascular endothelial growth factor receptor

WM = Waldenström’s macroglobulinemia

Please see the section of this Annual Report titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” for revenue by product.

We commercialize the following internally developed cancer medicines:

BRUKINSA is a next-generation small molecule inhibitor of BTK designed to maximize BTK occupancy and minimize off-target binding effects.

It is an orally active inhibitor that covalently binds to BTK, resulting in irreversible inactivation of the enzyme.

We are marketing BRUKINSA in the U.S., China, Europe, the UK, Canada, Australia, and other markets.

In the U.S., BRUKINSA received accelerated approval as a treatment for mantle cell lymphoma (“MCL”) in adult patients who have received at least one prior therapy (November 2019), and has since also been approved for patients with Waldenström’s macroglobulinemia (“WM”) and R/R marginal zone lymphoma (“MZL”) who have received at least one anti-CD20-based regimen.

The MCL and MZL indications were approved under accelerated approval based on overall response rate.

Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial.

In January 2023, BRUKINSA was approved by the U.S.

FDA for the treatment of adult patients with CLL or SLL.

In December 2023, the FDA approved a label update for BRUKINSA to include superior progression-free survival (“PFS”) results from the Phase 3 ALPINE trial comparing BRUKINSA against IMBRUVICA in previously treated patients with R/R CLL.

The FDA is currently reviewing a supplemental new drug application (“sNDA”) submission for BRUKINSA in R/R follicular lymphoma (“FL”) with a Prescription Drug User Free Act date in March 2024.

In Europe, BRUKINSA has received approval from the European Commission (“EC”) for the treatment of adult patients with WM who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy, as well as for the treatment of patients with R/R MZL and for the treatment of patients with CLL.

In November 2023, the EC approved BRUKINSA in combination with obinutuzumab for the treatment of adult patients with R/R FL who have received at least two prior lines of systemic therapy.

BRUKINSA is now approved to treat more patient populations in the EU than any other BTK inhibitor.

In China, BRUKINSA has received approval from the China National Medical Products Administration (“NMPA”) for treatment-naïve adults with CLL or SLL, treatment-naïve adults with WM, R/R CLL/SLL, R/R WM, and conditional approval for adult patients with MCL who have received at least one prior therapy.

Currently, all five approved indications for BRUKINSA are included in the updated National Reimbursement Drug List (“NRDL”) by the China National Healthcare Security Administration (“NHSA”).

BRUKINSA is approved across several indications in more than 65 markets as of February 2024.

Market Opportunity

1 unchanged sentence

They can be broadly categorized into non-Hodgkin’s lymphoma and Hodgkin’s lymphoma.

In 2022, estimated global revenues for BTK inhibitors were approximately $8.5 billion according to published reports.

In 2024, global revenues for BTK inhibitors were over $10 billion according to company reported financials.

Global revenues are projected to be more than $15 billion in 2028, according to published reports.

Please see the section of this Annual Report titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” for BRUKINSA net revenue generated in 2023 and 2024.

BRUKINSA is a next-generation, oral, small molecule inhibitor of BTK designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity.

With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.

BRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing.

We are marketing BRUKINSA in the U.S., Europe, China, the UK, Canada, Australia, Japan, Brazil, and other markets.

BRUKINSA has approvals in five indications, including CLL/SLL, WM, R/R MCL, R/R MZL, R/R FL and is approved in more than 70 countries.

In the U.S., BRUKINSA received accelerated approval from the U.S.

Food and Drug Administration (“FDA”) for MCL in adult patients who have received at least one prior therapy in November 2019.

It was then approved for patients with WM based on a head-to-head study vs ibrutinib, followed by an accelerated approval in R/R MZL patients who have received at least one anti-CD20-based regimen.

In January 2023, BRUKINSA was approved for the treatment of adult patients with CLL or SLL in both the treatment naive and relapsed setting based on two Phase 3 studies.

BRUKINSA is the only BTKi to demonstrate progression-free survival (“PFS”) superiority to ibrutinib in R/R CLL/SLL in all patient segments, including high-risk (17p/TP53).

In March 2024, BRUKINSA received accelerated approval from the FDA for R/R FL in combination with obinutuzumab.

In Europe, BRUKINSA received approval from the European Commission (“EC”) for the treatment of adult patients with WM who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy, as well as for the treatment of patients with R/R MZL and for the treatment of patients with CLL.

In November 2023, the EC approved BRUKINSA in combination with obinutuzumab for the treatment of adult patients with R/R FL who have received at least two prior lines of systemic therapy.

BRUKINSA is now approved to treat more patient populations in Europe than any other BTK inhibitor.

In China, BRUKINSA has received approval from the China National Medical Products Administration (“NMPA”) for treatment-naïve adults with CLL or SLL, treatment-naïve adults with WM, R/R CLL/SLL, TN & R/R WM, and conditional approval for adult patients with MCL who have received at least one prior therapy.

Currently, all approved indications for BRUKINSA are included in the updated National Reimbursement Drug List (“NRDL”) by the China National Healthcare Security Administration (“NHSA”).

BRUKINSA received approval in Japan for WM and CLL/SLL in December 2024.

TEVIMBRA (tislelizumab)

Market Opportunity

Globally, the top four PD-1/PD-L1 antibody medicines had revenues of approximately $45 billion in 2024 based on public reports.

The 2024 China PD-1/L1 market (net revenue) was approximately $3.4 billion.

Global revenues are projected to be approximately $50 billion in 2025 and will increase through 2028, according to published reports, driven by multiple factors including indication expansion, approvals and adoptions in earlier lines of therapies, further market penetration, and extension of duration of therapy.

TEVIMBRA is a humanized IgG4 monoclonal antibody against the immune checkpoint receptor programmed cell death protein 1 (“PD-1”) that we specifically designed to minimize binding to Fc receptor gamma (“FcγR”), which is believed to play an essential role in activating phagocytosis in macrophages, to minimize its negative impact on T effector cells.

Tislelizumab is approved in China in twelve indications:

• full approval for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma with high PD-L1 expression in combination with fluoropyrimidine and platinum chemotherapy;

• for first-line treatment of patients with advanced squamous non-small cell lung cancer (“NSCLC”) in combination with chemotherapy;

• for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy;

Tislelizumab is approved in China in fourteen indications:

• for neoadjuvant treatment in combination with platinum-based chemotherapy and for adjuvant treatment as monotherapy after surgery in patients with resectable stage II or III non-small cell lung cancer (“NSCLC”)’ for first-line treatment for patients with extensive-stage small cell lung cancer in combination with etoposide and platinum chemotherapy;

• for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma with high PD-L1 expression in combination with fluoropyrimidine and platinum chemotherapy;

• for first-line treatment of patients with unresectable, locally advanced or metastatic squamous NSCLC in combination with chemotherapy;

• for first-line treatment of patients with unresectable, locally advanced or metastatic non-squamous NSCLC, with epidermal growth factor receptor (“EGFR”) genomic tumor aberrations negative and anaplastic lymphoma kinase (“ALK”) genomic tumor negative in combination with pemetrexed and platinum chemotherapy;

• for second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy;

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• for first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma (“HCC”);

• for the treatment of patients with HCC who have received at least one systemic therapy;

• conditional approval for the treatment of patients with classical Hodgkin’s lymphoma (“cHL”) who received at least two prior therapies;

• for the treatment of patients with locally advanced or metastatic urothelial carcinoma (“UC”) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy;

• for patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high (“MSI-H”) or mismatch repair-deficient (“dMMR”) solid tumors.

Full approval for these indications is contingent upon results from ongoing randomized, controlled, confirmatory clinical trials.

• for the treatment of patients with advanced hepatocellular carcinoma who have received Sorafenib, Lenvatinib or systemic chemotherapy containing Oxaliplatin ;

• conditional approval for the treatment of patients with classical Hodgkin’s lymphoma (“cHL”) who received at least two prior lines of systemic chemotherapy regimens;

• conditional approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma (“UC”) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy;

• conditional approval for patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high (“MSI-H”) or mismatch repair-deficient (“dMMR”) solid tumors.

Full approval for those indications listed as having conditional approval is contingent upon results from ongoing confirmatory clinical trials.

Tislelizumab was included in the NRDL in 2020 for cHL and UC, in 2021 for non-squamous NSCLC, squamous NSCLC and HCC, in 2022 for locally advanced or metastatic NSCLC, MSI-H solid tumors, locally advanced or metastatic ESCC following progression or intolerance to prior first-line chemotherapy, and first-line recurrent or metastatic NPC, and in 2023 for first-line locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma with high PD-L1 expression and first-line unresectable locally advanced, recurrent or metastatic ESCC.

In addition, three supplemental Biologics License Applications (“sBLAs”) for tislelizumab for patients with first-line extensive stage small cell lung cancer (“ES-SCLC”) and for patients with first-line locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma (“GC/GEJ”) regardless of PD-L1 status and tislelizumab in combination with platinum-based doublet chemotherapy as neoadjuvant treatment for patients with NSCLC are under review by the Center for Drug Evaluation (“CDE”) of the NMPA.

In Europe, the EC has approved TEVIMBRA as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic ESCC after prior platinum-based chemotherapy, along with additional filings.

In the U.S., we have filed a Biologics License Application (“BLA”) with the FDA for TEVIMBRA as a treatment for patients with unresectable recurrent locally advanced or metastatic ESCC after prior systemic therapy.

Additionally, the FDA accepted for review a BLA for TEVIMBRA as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC.

We are evaluating tislelizumab in a broad pivotal clinical program for both solid tumor and hematological indications globally.

BeiGene has launched more than 17 potentially registration-enabling trials with tislelizumab, of which 11 Phase 3 randomized trials and 4 Phase 2 trials have already had positive readouts.

More than 900,000 patients have been prescribed TEVIMBRA globally to-date.

In September 2023, we announced that we had entered into an agreement with Novartis to regain worldwide rights to develop, manufacture, and commercialize TEVIMBRA.

Market Opportunity

Globally, the top four PD-1/PD-L1 antibody medicines had revenues of approximately $36 billion in 2022 based on public reports.

The 2022 China PD-1/L1 market (net revenue) was approximately $2.2 billion.

Global revenues are projected to be more than $50 billion by 2025 according to published reports, driven by multiple factors including indication expansion, approvals and adoptions in earlier lines of therapies, further market penetration, and extension of duration of therapy.

PARTRUVIX (pamiparib)

PARTRUVIX is a selective small molecule inhibitor of poly ADP-ribose polymerase 1 (“PARP1”) and PARP2 enzymes.

Pamiparib has demonstrated pharmacological properties such as brain penetration and PARP-DNA complex trapping in preclinical models.

In China, PARTRUVIX received conditional approval for treatment of patients with germline BRCA (“gBRCA”) mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy in May 2021.

Full approval for this indication is contingent upon results from ongoing corroborative trials confirming the clinical benefit of PARTRUVIX in this population.

PARTRUVIX was included in the 2021 NRDL in its approved indication.

In Europe, the EC has approved TEVIMBRA in six indications:

• for first-line treatment of adult patients with unresectable, locally advanced or metastatic ESCC whose tumors express PD-L1 with a tumor area positivity (“TAP”) score > 5%, in combination with platinum-based chemotherapy;

• as monotherapy is indicated for the treatment of adult patients with unresectable, recurrent, locally advanced or metastatic ESCC after prior chemotherapy;

• for the first-line treatment of adult patients with non-squamous NSCLC, whose tumors have PDL1 expression on > 50% of tumor cells with no EGFR or ALK positive mutations and who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC, in combination with pemetrexed and platinum-containing chemotherapy;

• for the first-line treatment of adult patients with squamous non-small cell lung cancer who have:

locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC in combination with carboplatin and either paclitaxel or nab-paclitaxel;

• as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer after prior platinum-based therapy;

• for the first-line treatment of adult patients with HER-2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (“G/GEJ”) adenocarcinoma whose tumors express PD L1 with a TAP score > 5%, in combination with platinum and fluoropyrimidine-based chemotherapy.

In the U.S., the FDA has approved TEVIMBRA as a treatment for adult patients with unresectable or metastatic ESCC after prior systemic therapy that did not include a PD-(L)1 inhibitor and as the first-line treatment of unresectable or metastatic HER2-negative G/GEJ in adults whose tumors express PD-L1 (≥1) in combination with platinum and fluoropyrimidine-based chemotherapy.

Additionally, one Biologics License Application (“BLAs”) for TEVIMBRA is under review for first-line treatment of patients with unresectable, locally advanced, or metastatic ESCC.

In Japan, one Japanese New Drug Application (“J-NDA”) is under review by the Pharmaceuticals and Medical Devices Agency (“PMDA”) for first- and second-line treatment of ESCC.

We have received regulatory approvals for TEVIMBRA marketing applications in multiple geographies, including the EU (comprising 27 countries plus Iceland and Norway) and 16 countries across North America, Europe, APAC, and other markets.

In-Licensed Products from Amgen

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In-Licensed Products from BMS

We commercialize the following cancer medicines in China under an exclusive license from BMS through 2024:

REVLIMID (lenalidomide) is an oral immunomodulatory medicine that was approved in China in 2013 for the treatment of MM in combination with dexamethasone in adult patients who have received at least one prior therapy.

In February 2018, REVLIMID received NMPA approval of a new indication for the treatment of MM in combination with dexamethasone in adult patients with previously untreated MM who are not eligible for transplant.

REVLIMID was listed on the NRDL in June 2017.

In November 2019, we announced that REVLIMID received formal inclusion on the NRDL in China for R/R MM.

In November 2020 our sNDA for the use of REVLIMID in combination with rituximab in adult patients with previously treated follicular lymphoma was approved by the NMPA.

VIDAZA (azacitidine for injection) is a pyrimidine nucleoside analog that has been shown to reverse the effects of DNA hypermethylation and promote subsequent gene re-expression.

VIDAZA was approved in China in April 2017 for the treatment of intermediate-2 and high-risk myelodysplastic syndromes (“MDS”), chronic myelomonocyte leukemia (“CMML”) and acute myeloid leukemia (“AML”) with 20% to 30% blasts and multi-lineage dysplasia.

In January 2018, VIDAZA became commercially available in China.

In addition to REVLIMID and VIDAZA, we previously commercialized ABRAXANE ® (paclitaxel albumin-bound particles for injectable suspension), a solvent-free chemotherapy approved for use in certain patients with metastatic breast cancer, in China until March 2020.

On March 25, 2020, the NMPA suspended the importation, sales and use of ABRAXANE in China previously supplied to us by BMS, and the drug was subsequently recalled by BMS.

This suspension was based on inspection findings at BMS’s contract manufacturing facility in the U.S.

Following the suspension and recall of ABRAXANE, we initiated an arbitration proceeding against BMS which has since been settled.

As part of the settlement agreement, the license and supply agreement covering REVLIMID and VIDAZA was terminated as of December 31, 2023, subject to our right to continuing selling inventory until it is sold out or December 31, 2024.

For additional information, please see the section of this Annual Report titled “Legal Proceedings”.

In-Licensed Products from EUSA Pharma

As part of our settlement agreement with BMS, our commercialization of the following cancer medicines licensed from BMS terminates as of February 2025:

• REVLIMID ® (lenalidomide), an oral immunomodulatory medicine

• VIDAZA ® (azacitidine for injection), a pyrimidine nucleoside analog that has been shown to reverse the effects of DNA hypermethylation and promote subsequent gene re-expression.

Other In-Licensed Products

We commercialize the following medicines in China under an exclusive license from EUSA Pharma:

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We began commercializing QARZIBA in December 2021.

In-Licensed Product from Bio-Thera

We commercialize the following product in China under an exclusive license from Bio-Thera:

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In China, Avastin is approved for the treatment of patients with metastatic colorectal cancer, NSCLC, glioblastoma, ovarian, fallopian tube or primary peritoneal, and cervical cancers.

POBEVCY was approved by the NMPA in China in November 2021 and launched in late 2021 for the treatment of patients with advanced, metastatic or recurrent NSCLC, and metastatic colorectal cancer.

POBEVCY was approved by the NMPA in China in November 2021 and launched in late 2021 for the treatment of patients with advanced, metastatic or recurrent NSCLC, metastatic colorectal cancer, recurrent glioblastoma, epithelial ovarian, fallopian tube, or primary peritoneal cancer and cervical cancer.

We have acquired the right to develop, manufacture and commercialize POBEVCY in China, including Hong Kong, Macau, and Taiwan.

In-Licensed Product from Luye Pharma

We commercialize the following product in China under an exclusive license from Luye Pharma:

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With its innovative microsphere formulation, Baituowei is able to ensure efficacy and safety while significantly improving patient experience.

Baituowei was approved by the NMPA in China in June 2023 for the treatment of patients with prostate cancer requiring androgen deprivation therapy and included in the NRDL in 2023, and was approved by the NMPA in China in September 2023 for treating breast cancer in premenopausal and perimenopausal women that can be treated with hormones.

Baituowei was approved by the NMPA in China in June 2023 for the treatment of patients with prostate cancer requiring androgen deprivation therapy and included in the NRDL in 2023 and was approved by the NMPA in China in September 2023 for treating breast cancer in premenopausal and perimenopausal women that can be treated with hormones and included in the NRDL in 2024.

Reimbursement and Market Access

Our sales are largely dependent on the availability and extent of coverage and reimbursement by third party payors.

In many markets these third parties are government health systems and in some markets such as the U.S.

there are also private payors such as private health insurers and health systems.

In many markets these third parties are government health systems and in some markets, such as the U.S., there are also private payors such as private health insurers and health systems.

As of December 31, 2024, we have commercialized our products in over 60 markets.

In the U.S., most health insurance coverage is provided by private insurers, often accessed via employer-sponsored plans, and the two main public insurance programs, Medicare and Medicaid.

All three types of programs usually have some type of coverage for pharmaceutical products.

There is no central list of covered pharmaceuticals in the U.S., as there is no single payer system.

As such, the prices paid for pharmaceuticals in the U.S.

We offer patient assistance programs in the U.S.

under our myBeiGene program.

This program seeks to enhance access to BRUKINSA and TEVIMBRA by assisting with obtaining reimbursement, co-pay assistance when allowed, temporary supply of free product for insurance delays, and free product assistance for some uninsured and underinsured patients.

The programs also seek to support patients and caregivers by providing education and information about BRUKINSA and TEVIMBRA and their approved indications, nurse advocates, and connecting patients to sources of support such as support groups and transportation/lodging assistance.

In China, there is one main payor, the government’s national health care coverage system, which provides Basic Medical Insurance to the majority (greater than 95%) of China’s approximately 1.4 billion people.

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As additional indications are included in the NRDL, the price of the medicine is reduced to reflect increased patient demand as a result of NRDL inclusion.

In the 2023 NRDL, some new rules were added into contract renewal rules:

• For Category 1 chemical drugs, therapeutic biological products, as well as Category 1 and 3 traditional Chinese medicines, manufacturers could apply for re-negotiation.

The price cut may not necessarily be higher than that of simple contract renewal rules.

If re-negotiation is failed, the drug will lose NRDL listing.

• Drugs that have been included in negotiation list for more than 4 years (including 4) could have a half price cut based on the simple contract renewal rules.

• Drugs that have been included in negotiation list for more than 8 years (including 8) could be transferred to Category B.

Several of our medicines are listed on the NRDL.

In the latest NRDL list announced in December 2023, the following medicines and indications have been included in the NRDL, effective January 1, 2024:

• Tislelizumab in eleven of its eligible approved indications:

– In combination with fluoropyrimidine- and platinum-based chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma with high PD-L1 expression (approved in February 2023 and included in the NRDL at the end of 2023);

– In combination with paclitaxel plus platinum-based or fluoropyrimidine- plus platinum-based chemotherapy, for the first-line treatment of patients with unresectable locally advanced, recurrent or metastatic ESCC (approved in May 2023 and included in the NRDL at the end of 2023);

– For the treatment of adult patients with locally advanced or metastatic non-squamous NSCLC who are negative for epidermal growth factor receptor (“EGFR”) and anaplastic mesenchymal lymphoma kinase (“ALK”) mutations and have progressed after or are intolerant of prior chemotherapy with platinum-containing regimens;

and adult patients with locally advanced or metastatic squamous NSCLC who are negative or unknown for EGFR and ALK mutations and have progressed after or are intolerant of prior chemotherapy with platinum-containing regimens (approved in January 2022 and included in the NRDL at the beginning of 2023);

In the latest NRDL list announced in November 2024, the following medicines and indications have been included in the NRDL, effective January 1, 2025:

• Tislelizumab in thirteen of its eligible approved indications:

– As a first-line treatment for patients with unresectable or metastatic HCC (approved in December 2023 and included in the NRDL at the end of 2024);

– In combination with etoposide and platinum chemotherapy as the first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC) (approved in June 2024 and included in the NRDL at the end of 2024);

– In combination with fluoropyrimidine and platinum chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma (approved in April 2024 and included in the NRDL at the end of 2024) 1 ;

– In combination with paclitaxel plus platinum- or fluoropyrimidine- and platinum-based chemotherapy, for the first-line treatment of patients with unresectable locally advanced, recurrent or metastatic ESCC (approved in May 2023 and included in the NRDL at the end of 2023);

– For the treatment of adult patients with locally advanced or metastatic non-squamous NSCLC with EGFR genomic tumor aberrations negative and ALK genomic tumor negative and have progressed after or did nottolerate prior platinum-based chemotherapy;

and of adult patients with locally advanced or metastatic squamous NSCLC, with EGFR and ALK negative or unknown, that have progressed after or did not tolerate of prior platinum-based chemotherapy (approved in December 2021 and included in the NRDL at the beginning of 2023);

– For the treatment of adult patients with advanced unresectable or metastatic MSI-H or dMMR solid tumors:

patients with advanced colorectal cancer with disease progression after prior treatment with fluoropyrimidines, oxaliplatin and irinotecan;

patients with other advanced solid tumors with disease progression after prior treatment and no satisfactory alternative treatment options (approved in March 2022 and included in the NRDL at the beginning of 2023);

– For the treatment of patients with locally advanced or metastatic ESCC who have progressed after or are intolerant of prior first-line standard chemotherapy (approved in April 2022 and included in the NRDL at the beginning of 2023);

– As a first-line treatment for patients with recurrent or metastatic NPC (approved in June 2022 and included in the NRDL at the beginning of 2023);

patients with advanced colorectal cancer (CRC) who had been treated fluoropyrimidines, oxaliplatin and irinotecan;

patients with other advanced solid tumors who develop disease progression after prior treatment and have no satisfactory alternative treatment options (approved in March 2022 and included in the NRDL at the beginning of 2023);

– For the treatment of patients with locally advanced or metastatic ESCC who have disease progression following or are intolerant to first-line standard chemotherapy (approved in April 2022 and included in the NRDL at the beginning of 2023);

– In combination with Gemcitabine and cisplatin, as first-line treatment in patients with recurrent or metastatic NPC (approved in June 2022 and included in the NRDL at the beginning of 2023);

– For use in combination with pemetrexed and platinum chemotherapy as a first-line treatment in patients with unresectable, locally advanced or metastatic non-squamous NSCLC, with EGFR genomic tumor aberrations negative and ALK genomic tumor negative (approved in June 2021 and included in the NRDL in 2021);

– For the treatment of patients with HCC who have been previously treated with at least one systemic therapy (conditionally approved in June 2021 and included in the NRDL in 2021);

1 The indication is an expansion of the previous indication “In combination with fluoropyrimidine- and platinum-based chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma with high PD-L1 expression”, which was approved in February 2023 and included in the NRDL at the end of 2023.

– For the treatment of patients with HCC who have been previously received Sorafenib, Lenvatinib or systemic chemotherapy containing Oxaliplatin (conditionally approved in June 2021 and included in the NRDL in 2021);

– For use in combination with paclitaxel and carboplatin as a first-line treatment in patients with unresectable, locally advanced or metastatic squamous NSCLC (approved in January 2021 and included in the NRDL in 2021);

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– For the treatment of patients with cHL who have received at least two prior therapies (conditionally approved in December 2019 and included in the NRDL in 2020).

• BRUKINSA in all five of its approved indications:

– For treatment-naïve patients with CLL or SLL (approved in April 2023 and included in the NRDL at the end of 2023);

– For treatment-naïve patients with WM (approved in April 2023 and included in the NRDL at the end of 2023);

– For the treatment of adult patients with WM who have received at least one prior therapy (conditionally approved in June 2021 and included in the NRDL in 2021;

converted to regular approval in May 2023);

• BRUKINSA in all four of its approved indications:

– In combination with obinutuzumab, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior lines of systemic therapy (approved in May 2024 and included in the NRDL at the end of 2024);

– For the treatment of patients with CLL or SLL (approved in April 2023 and included in the NRDL at the end of 2023) 1 ;

– For the treatment of patients with WM (approved in April 2023 and included in the NRDL at the end of 2023) 2 ;

– For the treatment of adult patients with MCL who have received at least one prior therapy (conditionally approved in June 2020 and included in the NRDL in 2020).

– For the treatment of adult patients with CLL/SLL who have received at least one prior therapy (conditionally approved in June 2020 and included in the NRDL in 2020;

converted to regular approval in May 2023).

• BAITUOWEI in one of its eligible approved indication:

• BAITUOWEI in both of its eligible approved indication:

– For the treatment of patients with breast cancer in premenopausal and perimenopausal women that can be treated with hormone therapy (approved in September, 2023 and included in the NRDL at the end of 2024);

– For the treatment of patients with prostate cancer requiring androgen deprivation therapy (approved in June 2023 and included in the NRDL at the end of 2023).

• SYLVANT in its approved indication:

– For the treatment of adult patients with MCD who are HIV negative and HHV-8 negative (approved in December 2021 and included in the NRDL at the end of 2023).

• XGEVA now listed as a Category B medicine and included all of the approved indications:

– Prevention of skeletal-related events (fracture, spinal cord compression, or the need for radiation or surgery to bone) in patients with MM and in patients with bone metastases from solid tumors (approved in November 2020 and included in the NRDL at the end of 2023);

– For the treatment of patients with GCTB that is unresectable or where surgical resection is likely to result in severe morbidity (first included in the NRDL in 2020).

• PARTRUVIX successfully renewed its approved indication:

– For the treatment of patients with gBRCA mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy (conditionally approved in May 2021 and included in the NRDL in 2021).

• KYPROLIS in its approved indication:

– In combination with dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received at least two lines of therapy, including proteasome inhibitor and immunomodulator.

(approved in July 2021 and included in the NRDL at the beginning of 2023).

Additionally, two of our medicines were listed in past NRDLs:

REVLIMID was included in the 2017 NRDL negotiation list and later received formal inclusion in the 2019 Category B list, while VIDAZA was listed in the 2018 NRDL negotiation list and later received formal inclusion to the 2020 Category B list.

• KYPROLIS successfully renewed its approved indication in October 2024:

In 2018, China started a new program to centrally purchase non-exclusive medicines for the nation’s health care system called “volume-based procurement,” or “group purchasing organization” or “4+7” when the program was first piloted in 11 major cities.

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We offer these types of patient assistance programs to our patients.

In the U.S., most health insurance coverage is provided by private insurers, often accessed via employer-sponsored plans, and the two main public insurance programs, Medicare and Medicaid.

All three types of programs usually have some type of coverage for pharmaceutical products.

Often this is through a pharmacy benefit manager (“PBM”).

The structure of the pharmacy benefit can be quite different for different beneficiaries depending on the negotiations between plan sponsors and plan purchasers.

There is no central list of covered pharmaceuticals in the U.S., as there is no single payer system.

As such, the prices paid for pharmaceuticals in the U.S.

We offer patient assistance programs in the U.S.

under our myBeiGene program.

This program seeks to enhance access to BRUKINSA by assisting with obtaining reimbursement, co-pay assistance when allowed, temporary supply of free product for insurance delays, and free product assistance for some uninsured and underinsured patients.

The programs also seek to support patients and caregivers by providing education and information about BRUKINSA and its approved indications, nurse advocates, and connecting patients to sources of support such as support groups and transportation/lodging assistance.

1 The indication included “both treatment-naïve patients and adult patients with CLL/SLL who have received at least one prior therapy”.

“For the treatment of adult patients with CLL/SLL who have received at least one prior therapy” was conditionally approved in June 2020 and included in the NRDL in 2020.

2 The indication included “both treatment-naïve patients and adult patients with WM who have received at least one prior therapy”.

“For the treatment of adult patients with WM who have received at least one prior therapy” was conditionally approved in June 2021 and included in the NRDL in 2021;

converted to regular approval in 2023.

Our Pipeline Products

The following table summarizes the status of our internally-discovered drug candidates as of February 26, 2024:

The following table summarizes our pipeline as of February 27, 2025:

The following table summarizes the status of our in-licensed drug candidates as of February 27, 2025:

Partner Molecule / Asset Indications Phase Commercial Rights

tarlatamab ^^

Amgen Tarlatamab ^

SCLC Phase 3 China

Xaluritamig Prostate cancer Phase 1 China

Sitravatinib † + Tislelizumab

NSCLC Phase 3 Asia, Australia, New Zealand

Sitravatinib † + Tislelizumab

ESCC Phase 2 China

Zanidatamab + chemo + Tislelizumab GEA Phase 3 Asia, Australia, New Zealand

Zymeworks Zanidatamab † + chemo + Tislelizumab GEA Phase 3 Asia, Australia, New Zealand

Zanidatamab † (monotherapy) BTC Phase 2 Asia, Australia, New Zealand

Zanidatamab BC, GC, GEA Phase 2 Asia, Australia, New Zealand

SpringWorks BGB-3245 1

Solid tumors Phase 1 Ex-Asia plus Japan

SEA-CD70 MDS, AML Phase 1 Asia, Australia, New Zealand

LBL-007 + Tislelizumab CRC, NSCLC, HNSCC, ESCC, Melanoma, NPC Phase 2 Ex-China

BG-C9074/DB1312 BC, EC, OC, CCA, sqNSCLC Phase 1a Global

CDK2i Breast cancer and other solid tumors Pre-clinical Global

INOVA-1, INOVA-2, cancer vaccine LNP NSCLC TAA and KRAS neoantigen, liver-specific LNP, and cancer vaccine LNP Pre-clinical Global

BiTE ® molecule;

Pfizer SEA-CD70 MDS, AML Phase 1 Asia, Australia, New Zealand

DualityBio BG-C9074/DB1312 BC, EC, OC, CCA, sqNSCLC Phase 1a Global

Ensem CDK2i Breast cancer and other solid tumors Phase 1 Global

CSPC MAT2Ai Solid tumors Phase 1 Global

Half-life extended BiTE ® ;

† XmAb ® is a registered trademark of Xencor, Inc.

*Mirati was acquired by Bristol Myers Squibb in January 2024;

1 By MapKure, a JV with SpringWorks

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BTC = biliary tract cancers;

CRC = colorectal cancer;

GC = gastric cancer;

GEA = gastroesophageal adenocarcinoma;

GEJC = gastroesophaegeal junction cancer;

HCC = hepatocellular carcinoma;

LNP= lipid nanoparticle;

MDS = myelodysplastic syndromes;

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SCLC = small cell lung cancer;

EC = endometrial cancer;

OC = ovarian cancer;

CCA = cholangiocarcinoma

Our Commercial- and Clinical-Stage Drug Candidates

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Securities and Exchange Commission (“SEC”), the Stock Exchange of Hong Kong Limited (“HKEx”), and the Shanghai Stock Exchange (“SSE”), copies of which are available on the Investors section of our website.

Commercial-Stage

BRUKINSA (zanubrutinib), a BTK Inhibitor

We are currently evaluating zanubrutinib in a broad pivotal clinical program globally to treat a number of B-cell malignancies.

Zanubrutinib has demonstrated sustained 24-hour BTK occupancy in both the peripheral blood and lymph node compartments in patients.

Zanubrutinib has demonstrated sustained 24-hour BTK occupancy in both the peripheral blood, bone marrow and lymph node compartments in patients.

Zanubrutinib is the only BTK inhibitor to demonstrate superior progression-free survival in R/R CLL versus IMBRUVICA ® (ibrutinib), an approved BTK inhibitor.

Overview of Clinical Development Program and Regulatory Status

We have announced BRUKINSA approvals around the world, including in the U.S., China, the EU, the UK, Canada, Australia, South Korea and Switzerland.

As of December 2023, 32 additional marketing authorization applications for BRUKINSA have been submitted and are under review, including by BeiGene and with support from our five distribution partners:

Adium Pharma in Latin America and the Caribbean, NewBridge Pharmaceuticals in the Middle East and North Africa, Erkim in Turkey, Nanolek in Russia, and Medison in Israel.

Based on the clinical data to date, we believe that BRUKINSA has a best-in-class profile, BeiGene has initiated broad global pivotal programs in multiple indications, including 11 registration or registration-enabling clinical trials.

Six of the 11 trials are Phase 3, 3 are designed to be registration-enabling Phase 2 trials, and 2 are confirmatory trials.

• ROSEWOOD A Global Randomized Study of Zanubrutinib plus Obinutuzumab vs Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma (FL) (NCT03332017).

• MAGNOLIA A Single-Arm Multicenter Study of Zanubrutinib subjects With Relapsed or Refractory Marginal Zone Lymphoma (MZL) (NCT03846427)

• A Phase 2, Single-Arm, Open-Label, Multicenter Study of the Bruton Tyrosine Kinase Inhibitor Zanubrutinib in subjects With CD79B Mutant Relapsed/Refractory Diffuse Large B-Cell Lymphoma (NCT05068440).

• ASPEN A Global Randomized Study of Zanubrutinib vs Ibrutinib in Subjects With Waldenström’s Macroglobulinemia (WM) (NCT03053440).

• SEQUOIA A Global Randomized Study of Zanubrutinib vs Bendamustine Plus Rituximab in subjects With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL) (NCT03336333).

• ALPINE A Global Randomized Study of Zanubrutinib vs Ibrutinib in subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL) (NCT03734016).

• MANGROVE A Randomized Global Study Comparing Zanubrutinib Plus Rituximab vs.

Clinical Development Updates and Regulatory Status

The global BRUKINSA clinical development program includes over 7,100 patients enrolled in more than 30 countries and regions across more than 35 trials.

BRUKINSA is approved in more than 70 markets, and more than 180,000 patients have been treated globally.

Five-year follow-up results from cohort 1 of the Phase 3 SEQUOIA study showed sustained PFS benefit (54-month PFS rate of 80%) with BRUKINSA in an all-comer population of patients with treatment-naïve (“TN”) CLL or SLL, with no new safety signals observed;

detailed data were presented at the annual ASH 2024 conference.

Five-year follow-up data of BOVen (zanubrutinib, obinutuzumab, venetoclax) study in TN CLL demonstrated frequent unmeasurable minimal residual disease (“uMRD”) in peripheral blood (96%) and bone marrow (92%), and uMRD was durable with a median MRD-free survival of 34 months;

detailed data were presented at the ASH 2024 conference.

Based on the clinical data to date, we believe that BRUKINSA has a best-in-class profile, we have initiated broad global pivotal programs in multiple indications, which led to regulatory approvals of five indications globally.

Current ongoing Phase 3 studies include:

A Randomized Global Study Comparing Zanubrutinib Plus Rituximab vs.

Bendamustine Plus Rituximab in subjects With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation (MCL) (NCT04002297).

• MAHOGANY Zanubrutinib Plus Obinutuzumab vs Lenalidomide plus Rituximab in Relapsed/ Refractory Follicular Lymphoma (FL) (NCT05100862).

• A Phase 2, Multicenter, Single-arm Study of Zanubrutinib in Patients With Previously Treated B-Cell Lymphoma Intolerant of Prior Treatment With Ibrutinib and/or Acalabrutinib.

• A Global Randomized Study of zanubrutinib vs tacrolimus in Primary Membranous Nephropathy (NCT05707377).

• A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of Zanubrutinib in Patients With Active Proliferative Lupus Nephritis (NCT04643470).

In addition, Nature Medicine (December 9, 2023) published compelling combination data of an investigator-initiated multicenter Phase 2 trial (NCT04271956) investigating BRUKINSA plus our anti-PD-1 TEVIMBRA (tislelizumab) in CLL patients with Richter’s transformation (“RT”).

Extended follow-up data from ALPINE trial was presented at Annual American Society for Hematology (“ASH”) 2023.

In December 2023, we received a U.S.

Label Update which includes PFS superiority in R/R CLL (HR 0.65, p=0.0024);

sustained with extended follow-up.

Based on positive readout from ROSEWOOD study, EC has granted approval for the treatment of R/R FL.

Finally, we are also investigating zanubrutinib in several combination studies in MCL, MZL and CLL/SLL, including a Phase 3 trial in combination with sonrotoclax in front-line CLL/SLL.

We continue to examine opportunities for zanubrutinib combos with both sonrotoclax and tislelizumab.

We continue to pursue regulatory approvals for BRUKINSA globally.

Besides our recent label updates in CLL/SLL in the U.S.

(December 2023) and FL in EU (November 2023) we expect continued regulatory decisions for some of our global submissions this year, including potential additional approvals in more than 10 markets.

Zanubrutinib Plus Obinutuzumab vs Lenalidomide plus Rituximab in Relapsed/ Refractory Follicular Lymphoma (FL) (NCT05100862).

We are also investigating zanubrutinib in several combination studies in MCL, MZL and CLL/SLL, including a Phase 3 trial in combination with sonrotoclax in front-line CLL/SLL.

We continue to examine opportunities for zanubrutinib combinations with both sonrotoclax and our BTK-CDAC (BGB-16673).

We continue to pursue regulatory approvals for BRUKINSA globally, including regulatory approval of a new tablet formulation, providing patients with more convenience and flexibility.

Sonrotoclax (BGB-11417), a Small Molecule Bcl-2 Inhibitor

Our differentiated BCL2 inhibitor, sonrotoclax, was intentionally designed to have higher potency and selectivity compared to venetoclax, with a shorter half-life and no accumulation.

We believe that efficacy signals and safety data from more than 1,800 patients enrolled by December 2024 in different indications and in different combinations continue to support the pre-clinical best-in-class promise.

Multiple trials with registration potential have completed enrollment or are nearing complete enrollment.

Single-arm Phase 2 trials of sonrotoclax monotherapy in R/R MCL (NCT05471843) and R/R CLL/SLL (NCT05479994) have completed enrollment.

Enrollment for Phase 2 trial in R/R WM (NCT05952037) is ongoing.

Our first Phase 3 randomized study in TN-CLL, CELESTIAL-TN CLL (NCT06073821), investigating sonrotoclax + BRUKINSA vs.

venetoclax + obinutuzumab completed enrollment in Q1 2025.

A Phase 2 study (NCT06637501) investigating sonrotoclax + BRUKINSA vs.

BRUKINSA to support TN-CLL registration for contribution of components has also started enrollment.

Clinical data of a Phase 1 trial investigating TN-CLL/SLL (NCT04277637) was presented at ASH 2024.

Sonrotoclax in combination with BRUKINSA continued to show very promising efficacy signals and a generally favorable safety profile in patients with TN CLL/SLL, especially deep and durable levels of undetectable MRD, and no laboratory or clinical tumor lysis syndrome (“TLS”), which is a key differentiator for our combination.

With these encouraging results, our BCL2 inhibitor sonrotoclax program is steadily progressing at the pivotal stage.

Additional pivotal development activities in R/R MCL and R/R CLL are under way.

BGB-16673, a BTK-targeted CDAC

BGB‑16673 is an orally available, brain-penetrating BTK targeting chimeric degradation activation compound (“CDAC”) designed to promote the degradation, or breakdown, of both wildtype and mutant forms of BTK, including those that commonly result in resistance to BTK inhibitors in patients who experience progressive disease.

BGB-16673 is the most advanced BTK degrader in the clinic, with more than 500 patients treated to date across the global clinical development program.

The FDA granted Fast Track Designation to BGB-16673 for the treatment of adult patients with R/R CLL/SLL who have been previously treated with at least two prior lines of therapy, including BTKi and BCL2 inhibitor, and adult patients with R/R MCL.

Data from the Phase 1/2 CaDAnCe-101 CLL study (NCT05006716) was presented at ASH 2024 and demonstrated that treatment with BGB-16673 was generally well tolerated in this heavily pretreated population of patients.

Promising antitumor activity was observed in patients with high-risk features, including in patients with BTK inhibitor-resistant mutations and those previously exposed to covalent BTK inhibitors, noncovalent BTK inhibitors, and BCL2 inhibitors.

No atrial fibrillation was observed in either the CLL/SLL or WM cohorts.

• From the cohort of CLL/SLL patients, BGB-16673 demonstrated an ORR of 94% at the 200mg dose.

Furthermore, amongst all doses delivered, 2 patients achieved a complete remission/complete remission with incomplete count recovery (CR/CRi).

Grade ≥3 TEAEs were reported in 57% of patients.

The most common grade ≥3 TEAEs (≥10%) were neutropenia/neutrophil count decreased (20%) and pneumonia (10%).

(Abstract 885)

• From the cohort of Waldenström’s macroglobulinemia patients, BGB-16673 demonstrated a 93% disease control rate (DCR) and 26% very good partial response (VGPR).

Grade ≥3 TEAEs were reported in 45% of patients.

The most common grade ≥3 TEAE (≥20%) was neutropenia/neutrophil count decreased.

(Abstract 860)

Phase 2 expansion in R/R CLL with pivotal intent has commenced and a confirmatory Phase 3 study is planned for early 2025.

In addition, we have announced intent to conduct a study comparing BGB-16673 to pirtobrutinib (ncBTKi with accelerated approval in R/R MCL and R/R CLL/SLL) and will work with health authorities to initiate this Phase 3 study.

TEVIMBRA (tislelizumab), an anti-PD-1 Antibody

Tislelizumab is a humanized monoclonal antibody against the immune checkpoint receptor PD-1 that is currently being evaluated in pivotal clinical trials globally and for which we plan to commence additional pivotal trials as a monotherapy and in combination with standard of care to treat various solid and hematological cancers.

Overview of Clinical Development Program and Regulatory Status

BeiGene has launched more than 17 potentially registration-enabling clinical trials globally, including 13 Phase 3 randomized trials and 4 Phase 2 trials intended to support regulatory submissions globally.

Our trials in lung cancer include:

• A global Phase 3 trial evaluating tislelizumab as a second- or third-line treatment compared to docetaxel in patients with locally advanced or metastatic NSCLC (NCT03358875);

• Two Phase 3 trials in China evaluating tislelizumab plus chemotherapy versus chemotherapy in squamous and non-squamous NSCLC (NCT03594747 and NCT03663205, respectively);

• A Phase 3 trial in China in 1L SCLC evaluating tislelizumab plus chemotherapy versus chemotherapy (NCT04005716);

• A Phase 3 trial in China of tislelizumab in combination with platinum-based doublet chemotherapy as neoadjuvant treatment for patients with NSCLC (NCT04379635).

Our trials in liver cancer include:

• A global Phase 3 trial comparing tislelizumab with sorafenib as first-line treatment for patients with HCC (NCT03412773);

• A global single-arm pivotal Phase 2 trial in second- or third-line unresectable HCC (NCT03419897).

Our trials in gastric cancer include:

• A global Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment for patients with gastric cancer (NCT03777657).

Our trials in lymphoma include:

• A Phase 3 trial in China comparing tislelizumab to salvage chemotherapy in patients with relapsed or refractory classical Hodgkin Lymphoma (cHL;

Tislelizumab is a humanized monoclonal antibody against the immune checkpoint receptor PD-1 that has been evaluated in pivotal clinical trials globally and for which we plan to commence additional pivotal trials in combination with standard of care to treat various solid and hematological cancers.

Clinical Development Updates and Regulatory Status

We have completed more than fourteen registration-enabling clinical trials in lung, liver, lymphoma, urothelial carcinoma, and nasopharyngeal cancer globally, including ten Phase 3 randomized trials and four Phase 2 trials supporting regulatory submissions globally.

We have three active studies in lymphoma, urothelial carcinoma, and solid tumors:

• A Phase 3 confirmatory trial in China comparing tislelizumab to salvage chemotherapy in patients with relapsed or refractory classical Hodgkin Lymphoma (cHL;

NCT04486391).

• A Phase 2 trial in China in patients with relapsed or refractory cHL (NCT03209973).

Our trials in urothelial carcinoma include:

• A Phase 3 trial in China in patients with locally advanced or metastatic urothelial carcinoma (NCT03967977);

• Phase 2 trial in China in patients with locally advanced or metastatic urothelial bladder cancer (NCT04004221).

Our trials in ESCC include:

• A global Phase 3 trial comparing tislelizumab with chemotherapy as second-line treatment for patients with advanced ESCC (NCT03430843);

• A global Phase 3 trial of tislelizumab in combination with chemotherapy as first-line treatment for patients with ESCC (NCT03783442);

• A Phase 3 trial in China of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized ESCC (NCT03957590).

Finally, our trials in solid tumors and nasopharyngeal cancer include:

• A Phase 3 confirmatory trial in China in patients with locally advanced or metastatic urothelial carcinoma (NCT03967977).

• A Phase 2 trial in China in patients with MSI-H/dMMR solid tumors (NCT03736889).

• A Phase 3 trial in China and Thailand of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in patients with nasopharyngeal cancer (NCT03924986).

As of December 2023, we had enrolled over 13,000 subjects in clinical trials of tislelizumab in more than 30 countries, including 3,500+ subjects outside of China.

These studies include 11 multi-regional registrational trials that are designed for global regulatory approvals.

Data from our trials thus far suggested that tislelizumab was generally well-tolerated and exhibited anti-tumor activity in a variety of tumor types.

PARTRUVIX (pamiparib), a PARP1 and PARP2 Inhibitor

Pamiparib is a selective small molecule inhibitor of PARP1 and PARP2 enzymes that is being evaluated as a potential monotherapy and in combinations for the treatment of various solid tumors.

Overview of Clinical Development Program and Regulatory Status

In China, pamiparib received conditional approval in May 2021 for treatment of patients with gBRCA mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy.

Full approval for this indication is contingent upon results from ongoing corroborative trials confirming the clinical benefit of pamiparib in this population.

In addition, our clinical development program includes a Phase 3 trial as a maintenance therapy in patients with platinum-sensitive recurrent OC (NCT03519230).

Clinical-Stage

Sonrotoclax (BGB-11417), a Small Molecule Bcl-2 Inhibitor

BGB-11417 is an investigational small molecule Bcl-2 inhibitor that is in late-stage clinical trials.

We have completed preclinical studies and have ongoing investigational new drug (“IND”) -enabling studies of BGB-11417, which demonstrate potent activity and high selectivity against the pro-apoptotic protein Bcl-2.

The molecule appears to be more potent than venetoclax and shows the potential to common venetoclax resistance mutations.

Further, it is more selective than venetoclax for Bcl-2 relative to Bcl-xL.

Designed with a shorter half-life, we believe this will lead to a more favorable tolerability profile and better handling.

Finally, we believe that it is well-positioned to be ideal backbone for combination therapies, especially with zanubrutinib and our BTK-CDAC in fixed duration treatment strategy.

The preliminary clinical data on pharmacokinetic/pharmacodynamic (“PK/PD”), efficacy and safety from more than 700 patients enrolled by December 2023 in different indications and in different combinations are consistent with the preclinical best-in-class hypothesis of a more potent and selective BCL2 inhibitor compared to venetoclax.

In TN-CLL sonrotoclax was safe and tolerable in combination with BRUKINSA;

with deep and durable responses.

Clinical data of a Phase 1 trial investigating TN-CLL/SLL, MZL (NCT04277637) and 1/ 2 trials investigating MM with t(11,14) was presented at ASH 2023.

With these encouraging results, our BCL2 inhibitor sonrotoclax (BGB-11417) program is steadily progressing at pivotal stage.

Clinical trials with registration-potential have already been initiated in R/R MCL globally (NCT05471843), R/R WM globally (NCT05952037) and R/R CLL/SLL for China only (NCT05479994).

Notably, we have just initiated the Phase 3 study of sonrotoclax + BRUKINSA vs venetoclax + obinutuzumab to support the development of sonrotoclax in the 1L CLL indication.

This study has started enrollment.

BGB-16673, a BTK-targeted CDAC

BGB-16673 is an investigational BTK‑targeting chimeric degradation activation compound (“CDAC”) active against both wild‑type and mutant BTK.

BGB‑16673 has demonstrated preclinical antitumor activity in models with wild‑type BTK and models with BTK inhibitor–resistant mutations commonly observed in patients who have progressed on prior BTK inhibitor treatment.

A Phase 1 open‑label, dose‑escalation, and dose‑expansion trial (NCT05006716) in adult patients with R/R B‑cell malignancies is currently enrolling.

Preliminary results are presented at ASH 2023.

We expect to initiate dose expansion in 2024.

BGB-10188, a PI3Kδ Inhibitor

BGB-10188 is an investigational PI3Kδ inhibitor being evaluated in a Phase 1 clinical trial ( NCT04282018 ) as monotherapy or in combination with BRUKINSA in hematology malignancies, or in combination with tislelizumab in solid tumors.

BGB-21447, a Bcl-2 Inhibitor

BGB-21447 is an investigational Bcl-2 inhibitor being evaluated in a Phase 1 clinical trial ( NCT05828589 ) as monotherapy in mature B-cell malignancies.

In preclinical studies, BGB-21447 shows additional potency and selectivity, with a longer half-life than sonrotoclax.

We believe the differentiated profiles of sonrotoclax and BGB-21447 may lead to unique development options for these programs.

Ociperlimab (BGB-A1217), a TIGIT Inhibitor

As of December 2024, we had enrolled over 14,000 subjects in clinical trials of tislelizumab monotherapy or in combination in more than 35 countries, including 4,700+ subjects outside of China.

These studies include eight multi-regional registrational trials that are designed for global regulatory approvals.

Data from our trials thus far have suggested that tislelizumab was generally well-tolerated and exhibited anti-tumor activity in a variety of tumor types.

In 2024, we terminated a Phase 3 trial in China of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized ESCC (NCT03957590).

Ociperlimab (BGB-A1217), an anti-TIGIT Antibody

Ociperlimab (BGB-A1217) is an investigational humanized IgG1-variant monoclonal antibody directed against TIGIT.

An immune checkpoint molecule, ociperlimab is currently being investigated in a global Phase 3 trial, AdvanTIG-302 (NCT04746924), in combination with tislelizumab in NSCLC.

As of December 2023, more than 2,000 subjects have been enrolled across the ociperlimab development program, which includes eight global trials in patients with lung cancers, esophageal squamous cell carcinoma, and cervical cancer.

In December 2021 we announced an option, collaboration and license agreement with Novartis to develop, manufacture and commercialize ociperlimab in North America, Europe, and Japan.

In July 2023, the agreement was mutually terminated and we regained the full global rights for ociperlimab.

Due to the changing treatment paradigm, we discontinued AdvanTIG 301 (NCT04866017), a Phase 3 trial of ociperlimab in combination with its anti-PD-1 antibody tislelizumab versus AstraZeneca’s Imfinzi (durvalumab) following concurrent chemoradiotherapy in patients with stage III unresectable NSCLC.

We will continue patient enrollment in AdvanTIG-302, while evaluating all available data to inform future development opportunities with ociperlimab.

Zanidatamab, a bispecific HER2-targeted antibody

Zanidatamab, a novel investigational Azymetric ™ bispecific antibody targeting HER2, is currently in late-stage clinical development with Zymeworks Inc.

BeiGene has development and commercial rights to zanidatamab in Asia (excluding Japan), Australia, and New Zealand.

We are participating in three ongoing clinical studies with zanidatamab.

The first is a Phase 1/2 study (NCT04215978) in HER2-positive breast and gastric cancer.

The breast cancer arm combines zanidatamab with docetaxel, and the gastric cancer arm combines zanidatamab with our PD-1 inhibitor tislelizumab and chemotherapy.

The second study HERIZON-BTC-01 (NCT04466891) is a Phase 2b study in patients with advanced or metastatic HER2-amplified biliary tract cancers (“BTC”) in which zanidatamab is being used as monotherapy.

Positive topline results from this trial were announced in 2022 and presented at ASCO 2023.

We are continuing the global Phase 3 clinical trial (NCT05152147) examining zanidatamab in combination with chemotherapy with and without tislelizumab in HER2-positive gastroesophageal cancer.

Surzebiclimab (BGB-A425), a TIM-3 Inhibitor

Surzebiclimab (BGB-A425) is an investigational humanized IgG1-variant monoclonal antibody against T-cell immunoglobulin and mucin-domain containing-3.

We have an ongoing Phase 2 trial (NCT03744468) of surzebiclimab in combination with tislelizumab in NSCLC and HNSCC.

BGB-A445, an OX40 Agonist Antibody

BGB-A445 is an investigational agonistic antibody directed to the OX40 antigen.

BGB-A445 is a non-ligand competing antibody that does not disrupt OX40 to OX40 ligand engagement.

Preclinical experiments showed that BGB-A445 has increasing effectiveness at higher doses versus an antibody that was ligand-competing, which showed falling effectiveness at higher doses.

BGB-A445 has also showed in preclinical tests the potential to be combined with several agents.

BGB-A445 is being evaluated in a Phase 1 trial (NCT04215978) in patients with advanced solid tumors, a Phase 2 basket trial in melanoma, renal cell cancer and bladder cancer (NCT05661955), a Phase 2 umbrella trial in 1L NSCLC (NCT05635708), and a Phase 2 umbrella trial in 2L+ NSCLC (NCT06029127).

BGB-15025, a Small Molecule HPK1 Inhibitor

BGB-15025 is an investigational small molecule inhibitor of HPK1, which is a key negative feedback regulator of TCR signaling.

Inhibition of HPK1 leads to enhanced T-cell activation pre-clinically.

In addition, preclinical studies showed that BGB-15025 exhibits combination activity with tislelizumab and has a wide therapeutic window.

We initiated a Phase 1 trial (NCT04649385) of BGB-15025 alone and in combination with tislelizumab in patients with advanced solid tumors in 2021.

This trial is being conducted in multiple countries globally and has entered dose expansion.

BGB-15025 is also being tested in a 1L NSCLC umbrella study in combination with tislelizumab and other novel agents.

BGB-24714, a SMAC mimetic

BGB-24714 is an investigational Second Mitochondrial-derived Activator of Caspase (“SMAC”) mimetic currently enrolling in a Phase 1 clinical trial (NCT05381909) as monotherapy and in combination with paclitaxel, or in combination with chemoradiotherapy in advanced solid tumors.

As of December 2024, more than 2,000 patients have been enrolled across the ociperlimab development program.

We have completed patient enrollment in AdvanTIG-302 and will evaluate data when available to inform future development opportunities for ociperlimab.

BG-60366, an EGFR-targeted CDAC

BG-60366 is an investigational EGFR‑targeting CDAC being evaluated in a Phase 1 clinical trial (NCT06685718) as monotherapy in patients with EGFR-mutant Non-Small Cell Lung Cancer.

BG-89894 (SYH2039), a MAT2A Inhibitor

BG-89894 (SYH2039) is an investigational MAT2A inhibitor being evaluated in a Phase 1 clinical trial (NCT06568614) as monotherapy in patients with advanced or metastatic solid tumors.

We licensed this asset from CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd in December 2024.

BGB-58067, an MTA-Cooperative PRMT5 Inhibitor

BGB-58067 is an investigational MTA-Cooperative PRMT5 inhibitor being evaluated in a Phase 1 clinical trial (NCT06568614) as monotherapy in patients with MTAP deficiency advanced or metastatic solid tumors.

BG-T187, an anti-EGFRxMET trispecific antibody

BG-T187 is an investigational anti-EGFRxMET trispecific antibody being evaluated in a Phase 1 clinical trial (NCT06598800) as monotherapy or in combination with other therapeutic agents in patients with advanced solid tumors.

BGB-26808, a HPK-1 Inhibitor

BGB-26808 is a second-generation HPK-1 inhibitor with a different scaffold from BGB-15025 being evaluated in a Phase 1 clinical trial ( NCT05981703 ) as monotherapy or in combination with tislelizumab in participants with advanced solid tumors.

Lifirafenib (BGB-283) and BGB-3245, Inhibitors of RAF

Lifirafenib is an investigational novel small molecule inhibitor with RAF monomer and dimer inhibition activities.

Lifirafenib has shown antitumor activities in preclinical models and in cancer patients with tumors harboring BRAF V600E mutations, non-V600E BRAF mutations or KRAS/NRAS mutations.

We have been developing lifirafenib for the treatment of cancers with aberrations in the mitogen-activated protein kinase (“MAPK”), pathway, including BRAF gene mutations and KRAS/NRAS gene mutations where first generation BRAF inhibitors are not effective.

We believe that lifirafenib as monotherapy or in combination with other agents may have potential for treating various malignancies such as melanoma, NSCLC, and endometrial cancer.

BeiGene is working together with SpringWorks Therapeutics, Inc.

(“SpringWorks”) in a global clinical collaboration and has initiated a Phase 1b clinical trial (NCT03905148) to evaluate the safety, tolerability, and preliminary efficacy of lifirafenib in combination with SpringWorks’ investigational MEK inhibitor, mirdametinib (PD-0325901), in patients with advanced solid tumors.

In addition to the collaboration, BeiGene and SpringWorks formed a separate company, MapKure, LLC, to develop BGB-3245, an investigational, selective next-generation RAF kinase inhibitor discovered by BeiGene scientists.

MapKure has an ongoing Phase 1 clinical trial of BGB-3245 (NCT04249843) in patients with advanced or refractory tumors harboring specific v-RAF murine sarcoma viral oncogene homolog B (“B-RAF”) genetic mutations.

BGB-30813, a DGKζ Inhibitor

BGB-30813 is an investigational DGKζ inhibitor being evaluated in a Phase 1 clinical trial ( NCT05904496 ) as monotherapy and in combination with tislelizumab in participants with advanced or metastatic solid tumors.

BGB-A3055, an anti-CCR8 Antibody

BGB-A3055 is an investigational anti-CCR8 antibody being evaluated in a Phase 1 clinical trial ( NCT05935098 ) as monotherapy or in combination with tislelizumab in participants with advanced or metastatic solid tumors.

BGB-C354, an anti-B7H3 ADC

BGB-C354 is an investigational antibody drug conjugate targeting B7H3 being evaluated in a Phase 1 clinical trial (NCT06422520) as monotherapy or in combination with tislelizumab in patients with advanced solid tumors.

Gastro-Intestinal Cancer

Zanidatamab, a bispecific HER2-targeted antibody

Zanidatamab, a novel investigational ZIIHERA ® bispecific antibody targeting HER2, is currently in late-stage clinical development with Zymeworks Inc./Jazz Pharmaceuticals plc.

We have development and commercial rights to zanidatamab in Asia (excluding Japan), Australia, and New Zealand.

We are participating in one ongoing clinical study with zanidatamab, a global Phase 3 clinical trial (NCT05152147) examining zanidatamab in combination with chemotherapy with and without tislelizumab in HER2-positive gastroesophageal cancer.

The Phase 2b study in patients with advanced or metastatic HER2-amplified biliary tract cancers (“BTC”) in which zanidatamab is being used as monotherapy have been completed.

We are also participating with Jazz in a confirmatory study (NCT06282575) for 2L+ BTC.

A BLA for the BTC indication is under review by China NMPA as of May 2024 and Orphan Drug Designation (“ODD”) was issued by Ministry of Food and Drug Safety in South Korea in December 2024.

On November 20, 2024, the FDA granted accelerated approval of ZIIHERA to Jazz for previously treated unresectable or metastatic HER2-positive biliary tract cancer.

In July 2024, Jazz announced that the Marketing Authorisation Application or zanidatamab in 2L BTC was validated by the European Medicines Agency.

BG-C137, an anti-FGFR2b ADC

BG-C137 is an investigational antibody drug conjugate targeting FGFR2b being evaluated in a Phase 1 clinical trial (NCT06625593) as monotherapy in patients with advanced solid tumors.

BGB-53038, a Pan-KRAS Inhibitor

BGB-53038 is an investigational Pan-KRAS inhibitor being evaluated in a Phase 1 clinical trial (NCT06585488) as monotherapy and in combinations in patients with advanced or metastatic solid tumors with KRAS mutations or amplifications.

BGB-B2033, an anti-GPC3x4-1BB bispecific antibody

BGB-B2033 is an investigational anti-GPC3x4-1BB bispecific antibody being evaluated in a Phase 1 clinical trial (NCT06427941) as monotherapy or in combination with tislelizumab in patients with selected advanced or metastatic solid tumors.

BGB-B3227, an anti-MUC1xCD16A bispecific antibody

BGB-B3227 is an investigational anti-MUC1xCD16A bispecific antibody being evaluated in a Phase 1 clinical trial (NCT06540066) as monotherapy or in combination with tislelizumab in patients with advanced or metastatic solid tumors.

BG-C477, an anti-CEA ADC

BG-C477 is an investigational antibody drug conjugate targeting CEA being evaluated in a Phase 1 clinical trial (NCT06596473) as monotherapy in patients with selected advanced solid tumors.

Breast/Gynecologic Cancer

BGB-43395, a CDK4 Inhibitor

BGB-43395 is an investigational CDK4 inhibitor being evaluated in a Phase 1 clinical trial ( NCT06120283 ) as monotherapy or in combination with either fulvestrant or letrozole in participants with hormone receptor positive (“HR+”) and human epidermal growth factor 2 negative (“HER2-”) breast cancer (“BC”) and other advanced solid tumors.

BGB-43395 is an investigational CDK4 inhibitor being evaluated in a Phase 1 clinical trial ( NCT06120283 ) as monotherapy or in combination with either fulvestrant or letrozole in patients with hormone receptor positive (“HR+”) and human epidermal growth factor 2 negative (“HER2-”) breast cancer (“BC”) and other advanced solid tumors.

BG-68501, a CDK2 Inhibitor

BG-68501 is an investigational CDK2 inhibitor being evaluated in a Phase 1 clinical trial (NCT06257264) as monotherapy or in combination with fulvestrant with or without BGB-43395 (CDK4i) in patients with HR+ and HER2- BC and other advanced solid tumors.

BG-68501 is licensed from Ensem Therapeutics, Inc.

BG-C9074, an anti-B7H4 ADC

BG-C9074 is an investigational antibody drug conjugate targeting B7H4 being evaluated in a Phase 1 clinical trial (NCT06233942) as monotherapy or in combination with tislelizumab in patients with advanced solid tumors.

BG-C9074 is licensed from Duality Biologics (Suzhou) Co., Ltd.

BGB-21447, a Bcl-2 Inhibitor

BGB-21447 is an investigational Bcl-2 inhibitor being evaluated in a Phase 1 clinical trial ( NCT05828589 ) as monotherapy in BC and other solid tumors.

In preclinical studies, BGB-21447 shows additional potency and selectivity, with a longer half-life than sonrotoclax.

We believe the differentiated profiles of sonrotoclax and BGB-21447 may lead to unique development options for these programs.

BGB-45035, an IRAK4-targeted CDAC

BGB-45035 is an investigational IRAK4‑targeting chimeric degradation activation compound (“CDAC”) being evaluated in a Phase 1 clinical trial (NCT06342713) as monotherapy in healthy participants.

Our Preclinical Programs

We have a proprietary biology research platform that has allowed us to research and develop both small molecules and biologic molecules.

In the last decade, this platform has generated more than 10 clinical stage assets, including three internally-developed molecules that have been approved by regulatory bodies in the U.S., China, EU, and other markets, with other filings pending globally and planned to be submitted.

In the last decade, this platform has generated more than 30 clinical stage assets, including three internally-developed molecules that have been approved by regulatory bodies in the U.S., EU, China, and other markets, with other filings pending globally and planned to be submitted.

The platform is a full-process technology system spanning from early discovery to commercialization of oncology medicines based on multiple drug technology platforms that can be applied to oncology and other fields.

2 unchanged sentences

We anticipate advancing many of our preclinical drug candidates into the clinic in the next 12 months.

We believe that we have the opportunity to combine tislelizumab with our preclinical candidates to target multiple points in the cancer immunity cycle.

We believe that we have the opportunity to combine tislelizumab with our preclinical/clinical candidates to target multiple points in the cancer immunity cycle.

We also may seek to develop companion diagnostics that will help identify patients who are most likely to benefit from the use of our medicines and drug candidates.

Manufacturing and Supply

We manufacture our medicines and drug candidates internally and in some cases with the help of third-party CMOs.

We manufacture our medicines and drug candidates internally and in some cases with the help CMOs.

The manufacturing of our medicines and drug candidates is subject to extensive regulations that impose various procedural and documentation requirements governing recordkeeping, manufacturing processes and controls, personnel, quality control, and quality assurance, among others.

Our manufacturing facilities and the facilities of the CMOs we use to manufacture our medicines and drug candidates operate under current good manufacturing practice regulations (“cGMP”) conditions.

Our manufacturing facilities and the facilities of the CMOs we use to manufacture our medicines and drug candidates operate under current good manufacturing practice (“cGMP”) regulations conditions.

cGMP regulations are requirements for the production of pharmaceuticals that will be used in humans.

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We have manufacturing facilities for small molecule drugs and large molecule biologics in Suzhou and Guangzhou, China, respectively, to support the commercialization and potential future demand of our internally developed or in-licensed products.

We are also in the process of building a new campus for clinical R&D and biologics manufacturing in New Jersey, U.S.

Our manufacturing facility in Suzhou is over 13,000 square meters and consists of a manufacturing base for small molecule drug products with an annual production capacity of about 100 million tablets and capsules and a biologics clinical development production facility with 2 x 500 liters capacity to produce biologics candidates for clinical supply.

The facility meets or exceeds design criteria of the U.S., EU, and China regulatory requirements.

The facility previously received a manufacturing license to produce commercial volumes of BRUKINSA and PARTRUVIX for the China market and successfully passed FDA inspection for BRUKINSA in 2023.

In 2023, as a result of our growing commercial and clinical demands, we opened our new small molecule manufacturing facility nearby in Suzhou with the capability to produce up to 1 billion solid oral dosages annually.

This approximately 50,000 square meter facility is expected to replace our current Suzhou site and support our growing pipeline of small molecule medicines and drug candidates.

In July 2024, we opened our flagship U.S.

campus for clinical R&D and biologics manufacturing in New Jersey.

flagship manufacturing and clinical R&D facility is located on a 42-acre site at the Princeton West Innovation Park in Hopewell, New Jersey.

The Hopewell facility is positioned strategically in the Interstate 95 corridor of New Jersey, with a deep and rich talent pool, and has more than one million square feet of developable real estate for potential future expansion to cover our existing medicines and pipeline.

This site has 8,000 liters of large molecule biologics manufacturing capacity.

Our manufacturing facility in Suzhou is 52,000 square meters and consists of a manufacturing base for small molecule drug products with an annual production capacity of about 600 million tablets and capsules.

The facility meets or exceeds design criteria of the U.S., E.U., and China regulatory requirements, and has been in operation for clinical product supply since the beginning of 2024, with commercial supply expected to be put into operation in mid-2025.

The biologics manufacturing business at the former site in Suzhou will conclude at the end of February 2025, with some quality control testing continuing until Q3 2025.

Our state-of-the-art commercial-scale manufacturing facility of large molecule biologics in Guangzhou is approximately 158,000 square meters.

Phases 1 and 2 of the facility were completed in September 2019 and December 2020, respectively, with 24,000 liters of single use disposable capacity.

Additionally, total committed capacity has been increased to 64,000 liters, with an additional expansion of 10,000 liters mechanically completed in 2023 with qualification expected by the end of 2024.

Additionally, total committed capacity has been increased to 64,000 liters, with 8 x 5,000L bioreactors in Phase 3 qualified in 2024.

Phase 1 and 2 are currently approved for the end-to-end commercial production of tislelizumab for the China market.

We have purchased an adjacent tract of land to the south of the current site and expect opening in the first half of 2024.

The new campus will be equipped with the state-of-the-art ADC production facility and 2 x 500 liters biologics clinical capacity while reserving additional land for the next phase of expansion to support our growing pipeline of large molecule medicines and drug candidates.

With the ADC expansion, our Guangzhou manufacturing facility will have total biologics capacity of 65,000 liters.

We have almost completed construction at the U.S.

flagship manufacturing and clinical R&D facility at the 42-acre site at the Princeton West Innovation Park in Hopewell, New Jersey.

The property, located strategically in the Interstate 95 corridor of New Jersey, with a deep and rich talent pool, has more than one million square feet of developable real estate for potential future expansion to cover our existing medicines and pipeline.

This site will have 8,000 liters of large molecule biologics manufacturing capacity and is anticipated to be operational in summer 2024.

In April 2024, we opened a new campus equipped with a state-of-the-art ADC production facility and 2 x 500 liters biologics clinical capacity while reserving additional land for the next phase of expansion to support our growing pipeline of large molecule medicines and drug candidates.

With the 2 x 500 liters biologics clinical capacity expansion, our Guangzhou manufacturing facility now has a total biologics capacity of 65,000 liters.

Contract Manufacturing Organizations

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We select our third-party suppliers carefully by considering a number of factors, including their qualifications, relevant expertise, production capacity, geographic proximity, reputation, track record, product quality, reliability in meeting delivery schedules, and business terms.

With our U.S.

manufacturing site expected to open this year and continued partnership with global manufacturers, we continue to diversify our global supply network and do not anticipate any disruption to supply on account of our established strategy to maintain sufficient safety stock of our products.

We have commercial supply and related agreements with most of our manufacturing service providers.

For example, we entered into a commercial supply agreement with Catalent Pharma Solutions, LLC (“Catalent”) to produce BRUKINSA at Catalent’s Kansas City, Missouri site and have added Catalent’s facility in Winchester, Kentucky for clinical and commercial use in the U.S.

and other countries outside of China.

We currently source the active pharmaceutical ingredient for BRUKINSA from a supplier in China and full qualification of a supplier outside of China is near completion and will be soon active.

In addition, we entered into a commercial supply agreement with Boehringer Ingelheim Biopharmaceuticals (China) Ltd.

(“Boehringer Ingelheim”) for tislelizumab, which is being manufactured at Boehringer Ingelheim’s facility in Shanghai, China.

Additionally, we entered into an agreement with Novartis to regain worldwide rights to develop, manufacture, and commercialize tislelizumab.

We will continue to work with Novartis on development, regulatory and manufacturing priorities.

Novartis will manufacture tislelizumab for many markets worldwide and explore its potential in combination with their oncology assets.

With our internal manufacturing capabilities and continued partnership with global contract manufacturers, we continue to diversify our global supply network and do not anticipate any disruption to supply on account of our established strategy to maintain sufficient safety stock of our products.

We have commercial supply and related agreements with our manufacturing service providers.

The FDA has approved an ex-China active pharmaceutical ingredients (“API”) source in January 2025, with EMA approval pending.

For our commercial and clinical stage products in-licensed from Amgen, BMS and others, we rely on the licensors and their manufacturing facilities or their CMOs for the supply of those medicines and drug candidates.

Our agreements with the outsourced suppliers engaged by us generally set out terms, including product quality or service details, technical standards or methods, delivery terms, agreed price and payment, and product inspection and acceptance criteria.

We are generally allowed to return any products that fail to meet specified quality standards.

Our outsourced suppliers procure raw materials themselves.

Typically, outsourced suppliers request settlement of payment within 30 days from the date of invoice.

Either party may terminate the agreements by serving notice to the other party under certain circumstances.

We generally obtain raw materials for our manufacturing activities from various suppliers who we believe have sufficient capacity to meet our demands.

Raw materials and starting materials used at our facilities in Beijing and Suzhou include active pharmaceutical ingredients custom-made by our third-party CROs and excipients, which are commercially available from well-known vendors that meet the requirements of the relevant regulatory agencies.

Raw materials and starting materials used at our facilities in Beijing and Suzhou include APIs custom-made by our third-party CROs and excipients, which are commercially available from well-known vendors that meet the requirements of the relevant regulatory agencies.

The core raw materials used in manufacturing at our Guangzhou facility are genetically modified cell lines that we have co-developed and licensed from Boehringer Ingelheim and other third parties.

We typically order raw materials on a purchase order basis and do not enter into long-term, dedicated capacity or minimum supply arrangements.

We pay for our purchases of raw materials on credit.

Credit periods granted to us by our suppliers generally range from 30 to 60 days.

Our suppliers are generally not responsible for any defects in our finished products.

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The parties are subject to specified exclusivity requirements in China and the rest of the world.

In connection with our ongoing assessment of the Amgen Collaboration Agreement cost-share contributions, we determined that our further investment in the development of AMG 510 was no longer commercially viable for BeiGene.

As a result, in February 2023, we entered into an amendment to the Amgen Collaboration Agreement to (i) stop sharing costs with Amgen for the further development of AMG 510 during the period starting January 1, 2023 and ending August 31, 2023;

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and Amgen entered into an Amendment No.

3 (the “Third Amendment”) to the Share Purchase Agreement, pursuant to which Amgen elected to relinquish its right to appoint a designated director to the Company’s board of directors on account of the Company’s global growth.

3 to the Share Purchase Agreement, pursuant to which Amgen elected to relinquish its right to appoint a designated director to the Company’s board of directors on account of the Company’s global growth.

The Company has retained Anthony C.

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Hooper was most recently re-elected by shareholders in 2022 to serve a three-year term ending 2025.

Novartis Collaboration

Collaboration and License Agreement for Tislelizumab

On January 11, 2021, BeiGene Switzerland entered into a Collaboration and License Agreement, which became effective on February 26, 2021 (the “Novartis Collaboration and License Agreement”) with Novartis, pursuant to which Novartis will have the right to develop, manufacture and commercialize tislelizumab in the U.S., Canada, Mexico, member countries of the EU, UK, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan (the “Licensed Territory”).

Under the Novartis Collaboration and License Agreement, we received an upfront cash payment of $650 million from Novartis.

Additionally, we were eligible to receive up to $1.3 billion upon the achievement of regulatory milestones, $250 million upon the achievement of sales milestones, and tiered royalties based on percentages of annual net sales of tislelizumab in the Licensed Territory ranging from the high-teens to high-twenties, with customary reductions in specified circumstances.

Under the Novartis Collaboration and License Agreement, we and Novartis agreed to jointly develop tislelizumab in the Licensed Territory, with Novartis responsible for regulatory submissions after a transition period and for commercialization upon regulatory approvals.

In addition, both companies could conduct clinical trials to explore potential combinations of tislelizumab with other cancer treatments.

We were responsible for funding the ongoing clinical trials of tislelizumab, and Novartis agreed to fund any new registrational, bridging, or post-marketing studies in the Licensed Territory.

Subject to specified conditions, both parties agreed to jointly fund other new clinical trials in the Licensed Territory agreed by the parties, provided that each party would be responsible for funding clinical trials evaluating tislelizumab in combination with its own- or third-party cancer treatments.

In September 2023, we mutually agreed to terminate the Novartis Collaboration and License Agreement.

Pursuant to the termination agreement, we regained full, global rights to develop, manufacture and commercialize tislelizumab with no royalty payments due to Novartis.

Upon termination we have no further performance obligations under the collaboration, and all remaining deferred revenue balances were recognized in full.

Novartis may continue its ongoing clinical trials and has the ability to conduct future combination trials with tislelizumab subject to our approval.

We agreed to provide Novartis with ongoing clinical supply of tislelizumab to support its clinical trials, while Novartis agreed to provide us with transition services to enable key aspects of the tislelizumab development and commercialization plan to proceed without disruption, including manufacturing, regulatory, safety and clinical support.

Option, Collaboration and License Agreement for Ociperlimab

On December 19, 2021, we entered into an Option, Collaboration and License Agreement (the “Novartis Option, Collaboration and License Agreement”) with Novartis, pursuant to which we granted Novartis an exclusive time-based option to receive an exclusive license to develop, manufacture and commercialize our investigational TIGIT inhibitor ociperlimab in the Licensed Territory.

Under the Novartis Option, Collaboration and License Agreement, we received an upfront cash payment of $300 million from Novartis and were eligible to receive an additional payment of $600 million or $700 million upon exercise by Novartis of an exclusive time-based option prior to mid-2023 or late-2023, respectively, subject to receipt of required antitrust approval.

Additionally, following the option exercise, we were eligible to receive up to $745 million upon the achievement of regulatory approval milestones, $1.15 billion upon the achievement of sales milestones, and tiered royalties based on percentages of annual net sales of ociperlimab in the Licensed Territory ranging from the high-teens to mid-twenties, with customary reductions in specified circumstances.

Under the Novartis Option, Collaboration and License Agreement, during the option period, Novartis agreed to initiate, conduct and fund additional global clinical trials of ociperlimab in combination with tislelizumab in selected tumor types and we agreed to expand enrollment in two ongoing trials.

Additionally, following the option exercise, the companies agreed to jointly develop ociperlimab in the Licensed Territory, with Novartis sharing development costs of global trials and responsible for regulatory submissions after a transition period and for commercialization upon regulatory approvals in the Licensed Territory.

We were initially responsible for supplying ociperlimab to Novartis, with Novartis having the right to conduct manufacturing for its use in the Licensed Territory after successful transfer of the manufacturing process.

In July 2023, we mutually agreed to terminate the Novartis Option, Collaboration and License Agreement.

Pursuant to the termination agreement, we regained full, global rights to develop, manufacture and commercialize ociperlimab.

Upon termination we have no further performance obligations under the collaboration, and all remaining deferred revenue balances were recognized in full.

Celgene License and Supply Agreement

On July 5, 2017, we and Celgene Logistics Sàrl, now a wholly-owned subsidiary of BMS, entered into a License and Supply Agreement, pursuant to which we were granted the right to exclusively distribute and promote BMS’s approved cancer therapies, REVLIMID, VIDAZA and ABRAXANE in China, excluding Hong Kong, Macau and Taiwan.

In addition, if Celgene decided to commercialize a new oncology product through a third party in the licensed territory during the first five years of the term, we had a right of first negotiation to obtain the right to commercialize the product, subject to certain conditions.

We subsequently assigned the agreement to our wholly-owned subsidiary, BeiGene Switzerland.

On March 25, 2020, the NMPA suspended the importation, sales and use of ABRAXANE in China previously supplied to us by BMS, and the drug was subsequently recalled by BMS.

This suspension was based on inspection findings at BMS’s contract manufacturing facility in the U.S.

Additionally, in October 2021, BMS provided 180-days’ notice to us, which we dispute, purporting to terminate our license to market ABRAXANE in China.

We initiated an arbitration proceeding against BMS asserting that it breached the terms and conditions of the license and supply agreement.

In August 2023, we entered into a settlement agreement which terminated the License and Supply Agreement on December 31, 2023, subject to our right to continue selling all inventory of REVLIMID and VIDAZA until sold out or December 31, 2024, whichever is earlier.

For additional information, please see the sections of this Annual Report titled “Legal Proceedings” and Footnote 17 of “Notes to the Consolidated Financial Statements”.

Intellectual Property

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We have filed patent applications and obtained patents in the U.S.

and other countries and regions, such as China and Europe, relating to our medicines and certain of our drug candidates, and are pursuing additional patent protection for them and for our other drug candidates and technologies.

and other countries and regions, such as Europe and China, relating to our medicines and certain of our drug candidates, and are pursuing additional patent protection for them and for our other drug candidates and technologies.

We sometimes rely on trade secrets to protect aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection, including our manufacturing processes.

We also rely on know-how, continuing technological innovation and in-licensing opportunities to develop, strengthen, and support our development programs.

Additionally, in various markets, a period of regulatory exclusivity may be provided for drugs upon approval.

The scope and term of such regulatory exclusivity will vary but, in general, the period will run concurrently with the term of any existing patent rights associated with the drug at the time of approval.

As of February 14, 2025, we owned 63 issued U.S.

patents, 46 issued China patents, a number of pending U.S.

and China patent applications, and corresponding patents and patent applications internationally.

patents, 15 issued European patents, 28 issued Japanese patents, 70 issued China patents, a number of pending patent applications in the U.S., Europe, Japan and China, and corresponding issued patents and pending patent applications internationally.

The key patents for our medicines and late-stage clinical drug candidates as of February 14, 2025, are summarized below:

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(zanubrutinib)

Compound and composition 2034

Oral dosage form 2034

Use for modulating Bruton’s tyrosine kinase activity 2034

Composition of matter 2034

Pharmaceutical composition 2034

Method of treatment 2034

Crystalline forms 2037

Use for the treatment of mantle cell lymphoma 2037

Use for the treatment of B-cell proliferative disorder 2037

Use for the treatment of B-cell proliferative disorder 2043

China Compound and composition 2034

China Crystalline forms 2037

(Tislelizumab)

Antibodies 2033

Use for the treatment of cancer 2033

Antibodies and use for the treatment of cancer 2033

Antibodies 2033

China Antibodies 2033

Compound and composition 2031

Use for the treatment of cancer 2031

Compositions 2031

Crystalline forms 2037

China Compound and composition 2031

China Use for the treatment of cancer 2031

Crystalline forms 2037

Method of treatment 2037

Combination use 2039

Method of treatment 2043

Europe Composition of matter 2034 2

Europe Combination use 2037 3

Japan Composition of matter 2034

Japan Crystalline forms 2037

China Composition of matter 2034

China Crystalline forms 2037

China Combination use 2037

(tislelizumab)

Composition of matter 2033 4

Composition of matter 2033

Polynucleotide 2033

Method of treatment 2033

Europe Composition of matter for antibodies 2033 5

Japan Composition of matter 2033

China Composition of matter 2033

China Composition of matter for antibodies 2033

China Polynucleotide 2033

China Method of treatment 2033

China Composition of matter 2031

Ociperlimab U.S.

Antibodies 2038

Composition of matter 2038

Japan Composition of matter 2038

China Composition of matter 2038

Sonrotoclax U.S.

Compound and composition 2039

China Compound and composition 2039

(1) The expected expiration does not include any additional term for patent term extensions.

Composition of matter 2039

Japan Composition of matter 2039

China Composition of matter 2039

Unless otherwise indicated, the expected expiration does not include any potential additional term for patent term extension (“PTE”), supplemental protection certificate (“SPC”) or pediatric exclusivity.

SPCs have been filed in various European countries and have been granted at least in France, Germany, Italy, Spain and the United Kingdom, extending the original patent term in those countries to 2036.

This patent is the subject of a pending opposition proceeding at the European Patent Office (EPO).

An application for PTE has been filed and if granted, will extend the original patent term to 2038.

SPCs have been pending or have been granted in various European countries, extending the original patent term in those countries, where granted, to 2038.

Under our collaboration with Amgen, we have the right to commercialize three medicines in China.

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China Formulation 2034

Although various extensions may be available, the life of a patent and the protection it affords, is limited.

We may face competition from generic medications for our medicines and any approved drug candidates even if we successfully obtain patent protection.

The scope, validity or enforceability of our or our collaborators’ patents may be challenged in court or other authorities, and we or they may not be successful in enforcing or defending those intellectual property rights and, as a result, may not be able to develop or market the relevant product exclusively, which would have a material adverse effect on any potential sales of that product.

Additionally, in China, the NMPA may approve a generic version of a brand-name medicine that still has patent protection.

As such, any issued patents may not protect us from generic or biosimilar competition for these medicines.

Under our license agreement with Amgen, they retain the responsibility, but are not obligated, to prosecute, defend and enforce the patents for the corresponding in-licensed products.

Under our license agreement with Luye, Luye retains the responsibility, but is not obligated, to prosecute the in-licensed patents for the corresponding in-licensed product, and BeiGene retains the responsibility, but is not obligated, to defend and enforce the patents for the corresponding in-licensed product.

The term of individual patents may vary based on the countries in which they are obtained.

In most countries in which we file, including the U.S.

and China, the term of an issued patent is generally 20 years from the earliest claimed filing date of a non-provisional patent application in the applicable country.

In the U.S., a patent’s term may be lengthened in some cases by a patent term adjustment, which extends the term of a patent to account for administrative delays by the United States Patent and Trademark Office (“USPTO”), in excess of a patent applicant’s own delays during the prosecution process, or may be shortened if a patent is terminally disclaimed over a commonly owned patent having an earlier expiration date.

In addition, in certain instances, a patent term can be extended to recapture a portion of the term effectively lost in obtaining FDA regulatory approval.

However, the restoration period cannot be longer than five years and the total patent term including the restoration period must not exceed 14 years following FDA approval.

In China, the Amended PRC Patent Law also provides both patent term adjustment and patent term extension.

Under our license agreement with Luye, Luye retains the responsibility, but is not obligated, to prosecute the in-licensed patents for the corresponding in-licensed product, and we retain the responsibility, but is not obligated, to defend and enforce the patents for the corresponding in-licensed product.

In certain foreign jurisdictions similar extensions as compensation for regulatory delays are also available.

The actual protection afforded by a patent varies on a claim by claim and country by country basis and depends upon many factors, including the type of patent, the scope of its coverage, the availability of any patent term extensions or adjustments, the availability of legal remedies in a particular country and the validity and enforceability of the patent.

We may rely, in some circumstances, on trade secrets and unpatented know-how to protect aspects of our technology.

We seek to protect our proprietary technology and processes, in part, by entering into confidentiality agreements with employees, consultants, scientific advisors and contractors and invention assignment agreements with our employees.

We also seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems.

Additionally, we currently own a number of registered trademarks and pending trademark applications.

We currently have registered trademarks for BeiGene, our corporate logo and product names and logos in the U.S., China, the EU and other jurisdictions, and we are seeking further trademark protection for BeiGene, our corporate logo, product names and logos, and other marks in jurisdictions where available and appropriate.

We operate in a highly competitive environment and our marketed products face intense competition in regulated markets around the world.

Our main competitors include other global research-based biopharmaceutical companies as well as smaller regional and local companies.

These companies participate in one or more activities including the development, production, and promotion of products that are intended to treat diseases or indications that are like products we currently market or are in the process of developing to market.

BRUKINSA – Conventional methods of treating lymphomas vary according to the specific disease or histology, but generally include chemotherapy, antibodies directed at CD20, a molecular marker found on the surface of B-cells, and, less frequently, radiation.

Recently, significant progress has been made in the development of new therapies for lymphomas, including BTK inhibitors.

The BTK inhibitor IMBRUVICA (ibrutinib), marketed by AbbVie and Janssen, was first approved by the FDA in 2013 for the treatment of patients with MCL who have received at least one prior therapy.

Since that time, ibrutinib has been approved in over 90 countries and regions and has expanded its indications.

Another BTK inhibitor, AstraZeneca’s CALQUENCE ® (acalabrutinib), was approved by the FDA in 2017 under accelerated approval for the treatment of patients with MCL who have received at least one prior therapy, and in November 2019 for use in adults with CLL/SLL as a single agent or in combination with obinutuzumab.

In January 2023, the FDA approved Lilly’s JAYPIRCA ™ (pirtobrutinib, a reversible BTK inhibitor) for the treatment of adult patients with R/R MCL after at least two lines of systemic therapy, including a BTK inhibitor.

In China, BRUKINSA competes with IMBRUVICA (ibrutinib), which received approval in 2017, YINUOKAI ® (orelabrutinib) from Innocare, which was approved in 2020, and CALQUENCE ® (acalabrutinib), which was approved in 2023.

TEVIMBRA – A number of PD-1 or PD-L1 antibody medicines have been approved by the FDA or EMA.

These include Merck’s KEYTRUDA ® (pembrolizumab), BMS’s OPDIVO ® (nivolumab), Roche’s TECENTRIQ ® (atezolizumab), AstraZeneca’s IMFINZI ® (durvalumab), Pfizer and Merck Sereno’s BAVENCIO ® (avelumab), Regeneron and Sanofi’s LIBTAYO ® (cemiplimab), GSK’s JEMPERLI ® (dostarlimab), and Junshi’s toripalimab.

In the global setting, several PD-1 or PD-L1 antibody agents are in late-stage clinical development in addition to tislelizumab.

In China, as of December 25, 2023, there are nine other approved PD-1 antibodies:

OPDIVO ® (nivolumab) and KEYTRUDA ® (pembrolizumab), Junshi’s TUOYI ® (toripalimab), Innovent’s TYVYT ® (sintilimab), Hengrui’s AIRUIKA ® (camrelizumab), Akeso’s ANNIKE ® (penpulimab), Gloria’s YUTUO ® (zimberelimab), Henlius’s HANSIZHUANG ® (serplulimab) and Lepu’s PUYOUHENG ® (pucotenlimab).

There are five approved PD-L1 antibody agents:

AstraZeneca’s IMFINZI ® (durvalumab), Roche’s TECENTRIQ ® (atezolizomab), CStone’s ZEJIEMEI ® (sugemalimab), Alphamab’s ENWEIDA ® (envafolimab), and Hengrui’s AIRUILI ® (adebrelimab).

Akeso’s PD-1xCTLA-4 bispecific antibody, KAITANNI ® (cadonilimab) was approved in China.

There are approximately 40 more PD-1 and PD-L1 agents in clinical development in China.

PARTRUVIX – We are competing with multiple PARP inhibitors in China.

AstraZeneca received approval for olaparib in August 2018.

Zai Labs obtained development and commercial rights for niraparib in China, and its NDA was approved by the NMPA in December 2019.

Fluzoparib from Hengrui/Hansoh was approved in December 2020.

Ociperlimab – We are aware of several pharmaceutical companies developing TIGIT antibodies, including Agenus, Arcus, BMS, Compugen, Roche/Genentech, Innovent, iTeos Therapeutics, Merck KGaA, Mereo BioPharma, Seagen, Junshi, Bio-Thera and Akeso.

To our knowledge, there are currently no approved anti-TIGIT antibodies and the most advanced agent is in Phase 3 development.

Sonrotoclax – We are aware of several pharmaceutical companies developing BCL2 inhibitors, including AbbVie, Roche, Ascentage Pharma, Fochon Pharma, Chia Tai Tianqing Pharmaceutical, AstraZeneca, Lupeng Pharmaceutical, TargetRx, Novartis, Servier, Zentalis Pharmaceuticals and InnoCare Pharma.

To our knowledge, venetoclax was approved by the FDA in April 2016, the EMA in December 2016 and by the NMPA in December 2020.

Many of the larger companies we compete with are well-capitalized and dedicate a significant number of financial resources to support their research and development, while using business development to supplement their internal pipelines.

We operate in a highly competitive global landscape, with our marketed products facing strong competition in regulated markets worldwide.

Our primary competitors include a diverse array of entities, from leading global research-based biopharmaceutical companies to agile regional and local firms.

These competitors are actively engaged in the development, production, and marketing of therapeutic products aimed at treating diseases similar to those in our current portfolio or pipeline.

This global competition underscores the breadth and depth of our industry, requiring us to maintain a robust and agile approach to R&D and excel in the commercialization of our innovative medicines across international markets.

The following table lists our key competitors for our principal products by competitor, product and territory, though it is not exhaustive.

Product Competitor Competitor-marketed product Territory

BRUKINSA AbbVie & Janssen IMBRUVICA U.S., Europe, Asia Pacific & China

AstraZeneca CALQUENCE U.S., Europe, Asia Pacific & China

Eli Lilly JAYPIRCA U.S., China & Japan

Innocare YINUOKAI China

TEVIMBRA Merck KEYTRUDA U.S., Europe, Asia Pacific & China

Bristol Meyers Squibb OPDIVO U.S., Europe, Asia Pacific & China

AstraZeneca IMFINZI U.S., Europe, Asia Pacific & China

Roche TECENTRIQ U.S., Europe, Asia Pacific & China

Merck KGaA BAVENCIO U.S., Europe, Asia Pacific & China

Regeneron & Sanofi LIBTAYO U.S., Europe, Asia Pacific & China

GSK JEMPERLI U.S., Europe, Asia Pacific & China

Junshi LOQTORZI U.S., Europe & China

Henlius HANSIZHUANG U.S., China & South Asia

Various Chinese companies 10+ products including PD-1/L1, PD-1xCTLA-4 China

In addition, we have several promising candidates in the pivotal development stage, including sonrotoclax, a BCL-2 inhibitor, and BGB-16673, a BTK-targeted degrader compound (“CDAC”).

These products are in various stages of clinical trials conducted globally and show potential in addressing unmet medical needs.

The following table lists our key competitors for our late-stage pipeline products by competitor, asset, latest development stage, and clinical trial territory, although it is not exhaustive.

Asset Competitor Competitor-asset Latest development stage Territory

Sonrotoclax AbbVie & Roche VENCLEXTA Approved Global

Ascentage Pharma Lisaftoclax Phase 3 Global

BGB-16673 Eli Lilly (Loxo Oncology) JAYPIRCA Approved Global

Nurix Therapeutics NX-5948 Phase 1 U.S.

AbbVie ABBV-101 Phase 1 Global

Furthermore, we are advancing several promising candidates through pivotal programs, including novel antibody-drug conjugates (“ADCs”), multispecific antibodies, and targeted therapies for lung, breast, and gastrointestinal cancers.

To our knowledge, Roche, AstraZeneca, Pfizer, and Merck are also developing new therapeutic options with similar mechanisms.

Our candidates are well-positioned in the market to offer first-in-class and/or best-in-class profiles, particularly in addressing the limitations of existing treatments and offering new alternatives to patients.

As a result, we must continuously invest and gain experience in the development, acquisition, and marketing of innovative and branded medicines and drug candidates to compete effectively in both current and future markets.

This requires us to devote substantial funds and resources to R&D to prevent or slow the erosion of the sales of our existing products and potential sales of products in development.

Please see the section of this Annual Report titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” for R&D expenses incurred in 2022 and 2023.

This requires us to devote substantial funds and resources to develop and generate evidence that prevents the erosion of existing products and delivers revenue from the next waves of innovation.

The main forms of competition include efficacy, safety, and cost.

The long-term success of our products depends on our ability to effectively demonstrate the value that each one of them offers to physicians, patients, and third-party payers.

This requires a much greater use of a direct sales force to realize significant revenues.

The long-term success of our products depends on our ability to effectively demonstrate the value to physicians, patients, and third-party payers.

This requires a much greater use of a direct sales force and promotion to realize significant revenues.

We also have, and will continue to enter into, co-promotion, contract sales force or other such arrangements with third parties, for example, where our own direct sales force is not large enough or sufficiently well-aligned to achieve maximum market penetration.

Furthermore, robust compliance system, science-based promotion model, and integrated management will also be competitive advantage in the industry in the long run, which we invest significant effort to establish.

Furthermore, robust compliance approaches, science-based promotion model, and integrated management will also be competitive advantages in the industry in the long run, in which we invest significant effort to establish and grow.

Government Regulation

Government authorities in the U.S., China, Europe and other jurisdictions extensively regulate the research and clinical development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing, and export and import of drugs like those we are developing and commercializing.

Government authorities in the U.S., Europe, China and other jurisdictions extensively regulate the research and clinical development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing, and export and import of drugs like those we are developing and commercializing.

Some jurisdictions also regulate drug pricing.

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In the U.S., the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act (“FDCA”), and its implementing regulations, and biologics under the FDCA, its implementing regulations, and the Public Health Service Act (“PHSA”), and its implementing regulations.

Drug Development Process

Drug and Biologics Product Development

The process required by the FDA before a drug or biologic may be marketed in the U.S.

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The conduct of the preclinical tests must comply with federal regulations and requirements, including GLP.

An IND sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data and any available clinical data or literature, to the FDA as part of the IND.

The sponsor must also include a protocol detailing, among other things, the objectives of the initial first-in-human clinical trial, dosing procedures, subject selection and exclusion criteria, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated if the initial clinical trial lends itself to an efficacy evaluation.

Some preclinical testing may continue even after the IND is submitted.

The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns or questions related to the proposed clinical trial and places the trial on a full clinical hold within that 30-day time period.

In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin.

The FDA also can impose partial clinical holds, for example, prohibiting the initiation of clinical trials of a certain duration or for a certain dose.

The results of preclinical testing, along with other information, including information about product chemistry, manufacturing and controls and a proposed clinical trial protocol are reviewed by the FDA as part of an IND.

The FDA may also impose full or partial clinical holds at any time before or during clinical trials due to safety concerns or noncompliance and may be imposed on all products within a certain class of products.

All clinical trials must be conducted under the supervision of one or more qualified investigators in accordance with GCP regulations.

These regulations require that all research subjects provide informed consent in writing before their participation in any clinical trial.

Further, an institutional review board (“IRB”) must review and approve the plan for any clinical trial before it commences at any institution, and the IRB must conduct continuing review and reapprove the study at least annually.

An IRB considers, among other things, whether the risks to individuals participating in the clinical trial are minimized and are reasonable in relation to anticipated benefits.

The IRB also approves the information regarding the clinical trial and the consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed.

Some trials are overseen by an independent group of qualified experts organized by the trial sponsor, known as a data safety monitoring board or committee.

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Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and safety reports must be submitted to the FDA and the investigators for serious and unexpected suspected AEs, any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator’s brochure, or any findings from other studies or animal or in vitro testing that suggest a significant risk in humans exposed to the product.

The sponsor must submit an IND safety report within 15 calendar days after the sponsor determines that the information qualifies for reporting.

The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within seven calendar days after the sponsor’s initial receipt of the information.

The FDA or the sponsor may suspend or terminate, or a data safety monitoring board may recommend the suspension or termination of, a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk.

Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the product has been associated with unexpected serious harm to subjects.

Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the product and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.

The manufacturing process must be capable of consistently producing quality batches of the product and, among other things, the manufacturer must develop methods for testing the identity, strength, quality and purity of the final product.

Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product does not undergo unacceptable deterioration over its shelf life.

The FDA, IRB, or the sponsor may suspend or terminate, or a data safety monitoring board may recommend the suspension or termination of, a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk.

Expanded Access

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However, if a company decides to make one of its investigational products available for expanded access, the FDA reviews each request for expanded access and determines if treatment may proceed.

We make available on our website the BeiGene contact information for requesting access to our investigational drugs and expected timeline for us to acknowledge receiving such requests.

We make available on our website our contact information for requesting access to our investigational drugs and expected timeline for us to acknowledge receiving such requests.

Review and Approval Processes

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The FDA will issue a complete response letter if the agency decides not to approve the NDA or BLA in its present form.

The complete response letter usually describes the specific deficiencies identified in the NDA or BLA that must be satisfactorily addressed before it can be approved.

The complete response letter describes the specific deficiencies identified in the NDA or BLA that must be satisfactorily addressed before it can be approved.

The deficiencies identified may be minor, for example, requiring labeling changes, or major, for example, requiring additional clinical trials.

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Expedited Programs

Fast Track Designation

The FDA has a fast track program that is intended to expedite or facilitate the process for reviewing new drugs, including biologics that meet certain criteria.

Specifically, new drugs are eligible for fast track designation if they are intended to treat a serious or life-threatening disease or condition for which there is no effective treatment and demonstrate the potential to address unmet medical needs for the disease or condition.

Fast track designation applies to the combination of the product and the specific indication for which it is being studied.

The sponsor of a new drug or biologic product candidate may request the FDA to designate the product candidate as a fast track product concurrently with, or at any time after, submission of an IND, and the FDA must determine if the product candidate qualifies for fast track designation within 60 days of receipt of the sponsor’s request.

In addition to other benefits, such as the ability to engage in more frequent interactions with the FDA, the FDA may initiate review of sections of a fast track product’s NDA or BLA before the application is complete.

This rolling review is available if the applicant provides, and the FDA approves, a schedule for the submission of each portion of the NDA or BLA and the applicant pays the applicable user fee.

However, the FDA’s time period goal for reviewing an application does not begin until the last section of the NDA or BLA is submitted.

Additionally, the fast track designation may be withdrawn by the FDA if the FDA believes that the designation is no longer supported by data emerging in the clinical trial process.

BRUKINSA was granted fast track designation by the FDA for the treatment of WM, MZL and R/R FL.

Tislelizumab was granted fast track designation by the FDA for the treatment of 1L HCC.

Accelerated Approval

Under FDA’s accelerated approval regulations, the FDA may approve a drug, including a biologic, intended to treat a serious or life-threatening disease or condition that generally provides meaningful therapeutic benefit to patients over available treatments and demonstrates an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.

In clinical trials, a surrogate endpoint is a marker, such as a laboratory measurement or clinical signs of a disease or condition that is thought to predict clinical benefit but is not itself a measure of clinical benefit.

Surrogate endpoints can often be measured more easily or more rapidly than clinical endpoints.

A product candidate approved on this basis is subject to rigorous post-marketing compliance requirements, including the completion of post-approval clinical trials to confirm the effect on irreversible morbidity or mortality or other clinical benefit.

Under the Food and Drug Omnibus Reform Act of 2022, the FDA can require, as appropriate, that post-approval confirmatory trials be underway prior to approval or within a specific time period after accelerated approval is granted.

Failure to conduct required post-approval studies with due diligence, or to confirm a clinical benefit during post-marketing studies, will allow the FDA to withdraw the drug from the market.

In general, all promotional materials for drug candidates approved under accelerated regulations are subject to prior review by the FDA unless otherwise informed by the agency.

BRUKINSA was granted accelerated approval by FDA for the treatment of adult patients with MCL who have received at least one prior therapy and for the treatment of adult patients with R/R MZL who have received at least one anti-CD20-based regimen.

Breakthrough Designation

Breakthrough therapy designation is intended to expedite the development and review of a drug or biologic if it is intended to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug or biologic, alone or in combination with one or more other drugs or biologics, may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

A sponsor may request that a product candidate be designated as a breakthrough therapy concurrently with, or at any time after, the submission of an IND, and the FDA must determine if the candidate qualifies for breakthrough therapy designation within 60 days of receipt of the sponsor’s request.

If so designated, the FDA shall expedite the development and review of the product candidate’s marketing application.

The designation may be rescinded if the product candidate does not continue to meet the criteria for breakthrough therapy designation.

BRUKINSA was granted breakthrough therapy designation by the FDA for the treatment of adult patients with MCL who have received at least one prior therapy.

Priority Review

The FDA may grant an NDA or BLA a priority review designation, which sets the target date for FDA action on the application at six months after the FDA accepts the application for filing.

Priority review is granted where there is evidence that the proposed product would be a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious condition.

If criteria are not met for priority review, the application is subject to the standard FDA review period of ten months after FDA accepts the application for filing.

Priority review designation does not change the scientific/medical standard for approval or the quality of evidence necessary to support approval.

The NDA for BRUKINSA was granted priority review by the FDA for the treatment of adult patients with MCL who have received at least one prior therapy.

The FDA may employ one of several tools to expedite the development and review of a medicine, including fast track designation, breakthrough therapy designation, priority review designation and accelerated approval.

Fast track designation is designed to facilitate the development and review of a medicine that treats a serious or life-threatening disease or condition and fills an unmet medical need.

Breakthrough therapy designation is intended to expedite the development and review of a medicine that treats a serious or life-threatening disease or condition and preliminary clinical evidence indicates substantial improvement over existing therapies.

Priority review designation means the FDA’s goal is to take action on an application within six months of filing.

The FDA may grant priority review designation to a medicine that would provide significant improvement in the safety or effectiveness of a treatment, diagnosis or prevention of a serious condition.

A product may also be eligible for accelerated approval if it treats a serious or life-threatening condition and generally provides a meaningful therapeutic benefit over available therapies.

In addition, such product must demonstrate an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality (“IMM”) that is reasonably likely to predict an effect on IMM or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.

If the FDA concludes that a drug or biologic shown to be effective can be safely used only if distribution or use is restricted, it will require such post-marketing restrictions, as it deems necessary to assure safe use of the product.

Under the Food and Drug Omnibus Reform Act of 2022 (“FDORA”), the FDA is now permitted to require, as appropriate, that such trials be underway prior to approval or within a specific time period after the date of approval for a product granted accelerated approval.

Additionally, under FDORA, the FDA has increased authority for expedited procedures to withdraw its accelerated approval for such drug or biologic if, for example, the confirmatory trial fails to verify the predicted clinical benefit of the product.

Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or that the time period for FDA review or approval may not be shortened.

Furthermore, fast track designation, priority review, accelerated approval, and breakthrough therapy designation do not change the standards for approval.

Pediatric Information

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Patent Term Restoration and Regulatory Exclusivity

Depending upon the timing, duration and specifics of FDA approval of the use of our drug candidates, some of our U.S.

In certain circumstances, some of our U.S.

patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Act.

The Hatch-Waxman Act permits a patent restoration term of up to five years as compensation for patent term lost during product development and the FDA regulatory review process.

The Hatch-Waxman Act permits a patent restoration term of up to five years as compensation for patent term lost during product development and FDA regulatory review process.

However, patent term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the product’s approval date.

The patent term restoration period is generally one-half the time between the effective date of an IND and the submission date of an NDA or BLA plus the time between the submission date of an NDA or BLA and the approval of that application, except that this review period is reduced by any time during which the applicant failed to exercise due diligence.

The patent term restoration period is generally one-half the time between the effective date of an IND and the submission date of an NDA or BLA, plus the time between the submission date of an NDA or BLA and the approval of that application.

Only one patent applicable to an approved product is eligible for the extension and the application for the extension must be submitted prior to the expiration of the patent.

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to the first applicant to gain approval of an NDA for a new chemical entity.

A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule or ion responsible for the action of the drug substance.

During the exclusivity period, the FDA may not accept for review an abbreviated NDA, or ANDA, or a 505(b)(2) NDA submitted by another company for another version of such drug where the applicant does not own or have a legal right of reference to all the data required for approval.

During the exclusivity period, the FDA may not accept for review an abbreviated NDA (“ANDA”) or a 505(b)(2) NDA submitted by another company for another version of such drug where the applicant does not own or have a legal right of reference to all the data required for approval.

However, such an application may be submitted after four years if it contains a certification of patent invalidity or non-infringement.

The FDCA also provides three years of data exclusivity for an NDA, 505(b)(2) NDA or supplement to an existing NDA if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example, for new indications, dosages or strengths of an existing drug.

The FDCA also provides three years of data exclusivity for an NDA, 505(b)(2) NDA or supplement to an existing NDA if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed to be essential to the approval of the application, for example, for new indications, dosages or strengths of an existing drug.

This three-year exclusivity covers only the conditions of use associated with the new clinical investigations and does not prohibit the FDA from approving ANDAs for drugs containing the original active agent.

Five-year and three-year exclusivity will not delay the submission or approval of a full NDA.

However, an applicant submitting a full NDA would be required to conduct or obtain a right of reference to all of the preclinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness.

Regulatory exclusivity in the U.S.

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Pediatric exclusivity, if granted, provides an additional six months of exclusivity for all formulations, dosage forms, and indications of the active moiety and, for drugs, patent terms.

This exclusivity, which runs from the end of other regulatory exclusivity and, for drugs, patent terms, may be granted based on the voluntary completion of a pediatric trial in accordance with an FDA-issued “Written Request” for such a trial, provided that at the time pediatric exclusivity is granted there is not less than nine months of term remaining.

This exclusivity may be granted based on the voluntary completion of a pediatric trial, provided that at the time pediatric exclusivity is granted there is not less than nine months of term remaining.

Orphan drug exclusivity is described below under “Orphan Drugs.”

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Interchangeability requires that a product is biosimilar to the reference product and the product must demonstrate that it can be expected to produce the same clinical results as the reference product and, for products administered multiple times, the biologic and the reference biologic may be switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic.

A reference biologic is granted 12 years of exclusivity from the time of first licensure of the reference product.

The first biologic product submitted under the abbreviated approval pathway that is determined to be interchangeable with the reference product is eligible for a period of exclusivity against other biologics submitted under the abbreviated approval pathway during which time the FDA may not determine that another product is interchangeable with the same reference product for any condition of use.

A reference biologic is granted 12 years of exclusivity from the time of first licensure of the product.

The FDA may approve multiple “first” interchangeable products so long as they are all approved on the same first day of marketing.

This exclusivity period, which may be shared amongst multiple first interchangeable products, lasts for the lesser of (i) one year after the first commercial marketing, (ii) 18 months after approval if there is no legal challenge, (iii) 18 months after the resolution in the applicant’s favor of a lawsuit challenging the biologic’s patents if an application has been submitted, or (iv) 42 months after the application has been approved if a lawsuit is ongoing within the 42-month period.

Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs, including biologics, intended to treat a rare disease or condition, generally one that affects fewer than 200,000 individuals in the U.S.

Orphan drugs are defined by the FDA as products intended to treat a rare disease or condition that affects less than 200,000 persons in the U.S.

or that affects more than 200,000 individuals in the U.S.

and for which there is no reasonable expectation that costs of research and development of the product for the indication can be recovered by sales of the product in the U.S.

Orphan drug designation must be requested before submitting an NDA or BLA.

After the FDA grants orphan drug designation, the generic identity of the drug or biologic and its potential orphan use are disclosed publicly by the FDA.

Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.

The first NDA or BLA applicant to receive FDA approval for a particular active ingredient to treat a particular disease or condition with FDA orphan drug designation is entitled to a seven-year exclusive marketing period in the U.S.

for that product, for that indication.

Among the other benefits of orphan drug designation are tax credits for certain research and a waiver of the NDA or BLA application user fee.

During the exclusivity period, the FDA may not approve any other applications to market the same drug for the same disease or condition, except in limited circumstances, such as if the second applicant demonstrates the clinical superiority of its product to the product with orphan drug exclusivity through a demonstration of superior safety, superior efficacy, or a major contribution to patient care.

“Same drug” means a drug that contains the same active moiety if it is a drug composed of small molecules, or the same principal molecular structural features if it is composed of macromolecules and is intended for the same use as a previously approved drug, except that if the subsequent drug can be shown to be clinically superior to the first drug, it will not be considered to be the same drug.

Orphan drug exclusivity does not prevent the FDA from approving a different drug for the same disease or condition, or the same drug for a different disease or condition.

BRUKINSA was granted orphan drug designation status by the FDA for the treatment of WM, CLL, FL, MCL and MZL (3 subtypes).

Tislelizumab was granted orphan drug designation status by the FDA for the treatment of ESCC, HCC and GC.

Sonrotoclax was granted orphan drug designation status by the FDA for the treatment of AML, MM, WM and MCL.

A company must request orphan drug designation prior to filing and, if granted, the FDA will not approve another sponsor’s marketing application for the same drug for the same indication for seven years.

Orphan drug exclusivity will not bar approval of another medicine for the same indication if it is shown to be clinically superior.

Disclosure of Clinical Trial Information

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Healthcare Reform

government and state legislatures have shown significant interest in implementing cost containment programs to limit the growth of government-paid health care costs, including price controls, restrictions on reimbursement and requirements for substitution of generic products for branded prescription drugs.

government and state legislatures have implemented cost containment programs to limit the growth of government-paid health care costs, including price controls, restrictions on reimbursement and requirements for substitution of generic products for branded prescription drugs.

Such adoption of government controls and tightening of restrictive policies could limit payments for pharmaceuticals.

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Further, the American Taxpayer Relief Act reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

Due to the Statutory Pay-As-You-Go Act of 2010, estimated budget deficit increases resulting from the American Rescue Plan Act of 2021, and subsequent legislation, Medicare payments to providers will be further reduced starting in 2025 absent further legislation.

In 2022, the Inflation Reduction Act of 2022 (“IRA”) was enacted containing provisions that reduce the out-of-pocket spending cap for Medicare Part D beneficiaries from $7,050 to $2,000 starting in 2025, thereby effectively eliminating the coverage gap;

The American Rescue Plan Act of 2021 eliminated the statutory Medicaid drug rebate cap, set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, beginning January 1, 2024.

These laws and regulations may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any of our product candidates for which we may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used.

The Inflation Reduction Act of 2022 (“IRA”) was enacted containing provisions that reduce the out-of-pocket spending cap for Medicare Part D beneficiaries from $7,050 to $2,000 starting in 2025, thereby effectively eliminating the coverage gap;

impose new manufacturer financial liability on certain drugs under Medicare Part D;

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The effects of the IRA on our business and the healthcare industry in general is not yet known.

In addition, President Biden has issued multiple executive orders seeking to reduce prescription drug costs.

In February 2023, HHS issued a proposal in response to an executive order from President Biden that includes a proposed prescription drug pricing model that will test whether targeted Medicare payment adjustments will sufficiently incentivize manufacturers to complete confirmatory trials for drugs approved through the FDA’s accelerated approval pathway.

Although a number of these proposed measures may require additional legislation to become effective, both the Biden administration and Congress have indicated that they will continue to seek new legislative measures to control drug costs.

Legislative and regulatory proposals have also been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products.

In addition, former President Biden issued multiple executive orders seeking to reduce prescription drug costs.

President Trump reversed some of President Biden’s executive orders including rescinding Executive Order 14087 entitled “Lowering Prescription Drug Costs for Americans.” President Trump may issue new executive orders designed to impact drug pricing.

Congress and the Trump administration have indicated that they will continue to seek new legislative measures to control drug costs.

The Centers for Medicare and Medicaid Services (“CMS”) published a final rule that gives states greater flexibility in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential health benefits required under the ACA for plans sold through such marketplaces.

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There has also been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed bills designed to bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for pharmaceutical products.

The HHS implemented a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through PBMs, unless the price reduction is required by law.

The HHS implemented a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers ("PBMs"), unless the price reduction is required by law.

The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a safe harbor for certain fixed fee arrangements between PBMs and manufacturers.

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These laws may impact, among other things, our sales, marketing and education programs.

In addition, we may be subject to patient privacy regulation by both the federal government and the states in which we conduct our business prior to and after receiving regulatory approval of our product candidates.

In addition, we may be subject to patient privacy, cybersecurity, trade, and national security regulation by both the federal government and the states in which we conduct our business prior to and after receiving regulatory approval of our product candidates.

Some of the laws that may affect our ability to operate are detailed below:

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A person or entity can be found guilty of violating the AKS without actual knowledge of the statute or specific intent to violate it.

In addition, the government may assert that a claim including items or services resulting from a violation of the AKS constitutes a false or fraudulent claim for purposes of the federal False Claims Act (“FCA”) or federal civil money penalties statute.

Violations of the AKS carry potentially significant civil fines and criminal penalties, including imprisonment, fines, administrative federal civil monetary penalties, and exclusion from participation in federal healthcare programs.

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We continue to evaluate what effect, if any, these rules will have on our business.

• The federal civil and criminal false claims and civil monetary penalty laws, such as the FCA, which impose criminal and civil penalties and authorize civil whistleblower or qui tam actions, against individuals or entities for, among other things:

• The federal civil and criminal false claims and civil monetary penalty laws, such as the federal False Claims Act (“FCA”), which impose criminal and civil penalties and authorize civil whistleblower or qui tam actions, against individuals or entities for, among other things:

knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false, fictitious or fraudulent;

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Similar to the federal AKS, a person or entity can be found guilty of violating HIPAA without actual knowledge of the statute or specific intent to violate it.

• As further amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”), HIPPA and their respective implementing regulations impose requirements on certain covered healthcare providers, health plans and healthcare clearinghouses as well as their respective business associates who perform services for them that involve the creation, maintenance, receipt, use, or disclosure of, individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information.

• As further amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”), HIPAA and their respective implementing regulations impose requirements on certain covered healthcare providers, health plans and healthcare clearinghouses as well as their respective business associates who perform services for them that involve the creation, maintenance, receipt, use, or disclosure of, individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information.

HITECH also created new tiers of civil monetary penalties, made civil and criminal penalties directly applicable to business associates, and gave state attorneys authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA laws and seek attorneys’ fees and costs.

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laws which govern the privacy and security of health and other personal information and which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

• The federal transparency requirements under the ACA, including the provision commonly referred to as the Physician Payments Sunshine Act, which require manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to Centers for Medicare & Medicaid Services information related to payments or other transfers of value made to physicians, certain other licensed health care practitioners and teaching hospitals.

• The federal transparency requirements under the ACA, including the provision commonly referred to as the Physician Payments Sunshine Act requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to Centers for Medicare & Medicaid Services information related to payments or other transfers of value made to physicians, certain other licensed health care practitioners and teaching hospitals.

Manufacturers are also required to disclose ownership and investment interest held by physicians and their immediate family members.

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officials for the purpose of obtaining or retaining business or otherwise seeking favorable treatment.

Similarly, foreign and state privacy laws may be broader and require greater protections than HIPAA.

• Executive Order 14117 on Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern prohibits transactions involving certain sensitive personal data categories, including health data, genetic data, and biospecimens, to countries of concern, including China.

The regulations also restrict investment agreements, employment agreements and vendor agreements involving such data and countries of concern.

Actual or alleged violations of these regulations may be punishable by criminal and/or civil sanctions, and may result in exclusion from participation in federal and state programs.

Similarly, state privacy laws may be broader and require greater protections than HIPAA.

These data privacy and security laws may differ from each other and often are not pre-empted by HIPAA, which may complicate compliance efforts.

For example, the State of California enacted the California Consumer Privacy Act of 2018 (“CCPA”), which gives California residents expanded rights to access and delete their personal information, opt out of certain personal information sharing, and receive detailed information about how their personal information is used.

CCPA provides for civil penalties for violations, as well as a private right of action for data breaches.

Further, the California Privacy Rights Act (“CPRA”) creates additional obligations with respect to processing and storing personal information.

We will continue to monitor developments related to the CPRA and anticipate additional costs and expenses associated with CPRA compliance.

states have also passed or are considering omnibus privacy legislation and industry organizations regularly adopt and advocate for new standards in these areas.

While the legislation and proposed regulations including the CCPA and CPRA contain an exception for certain activities that involve protected health information subject to HIPAA, we cannot yet determine the impact the CCPA, CPRA or other such future laws, regulations and standards may have on our business.

Additionally, we are subject to state equivalents of each of the healthcare laws described above, among others, some of which may be broader in scope and may apply to healthcare services reimbursed by any third-party payor, not just governmental payors, but also private insurers.

For example, certain states have passed privacy laws that grant consumers rights to access and delete their personal information, opt out of certain personal information sharing, and receive detailed information about how their personal information is used.

Several states have passed laws specifically regulating consumer health data, which impose detailed consent requirements for uses and disclosures of such data.

These laws provide for civil penalties for violations, and key concepts in such laws have not yet been tested, leading to significant uncertainty concerning the application of such laws to our practices.

In addition, several of these laws allow for private claims, which could lead to litigation risks even where we believe we are in compliance.

Additionally, we are subject to state equivalents of each of the healthcare laws described above, some of which may be broader in scope and may apply to healthcare services reimbursed by any third-party payor, not just governmental payors, but also private insurers.

These laws are enforced by various state agencies and through private actions.

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Several states and local laws also impose other marketing restrictions or require pharmaceutical companies to make marketing or price disclosures to the state, require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers, and require the registration of pharmaceutical sales representatives.

State and foreign laws, including the European Union General Data Protection Regulation, also govern the privacy and security of health information in some circumstances, many of which differ from other laws, thus complicating compliance efforts.

There are ambiguities as to what is required to comply with these state requirements and if we fail to comply with such requirements we could be subject to penalties.

In the U.S., to help patients afford our approved product, we may utilize programs to assist them, including patient assistance programs and co-pay coupon programs for eligible patients.

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In the EU, the General Data Protection Regulation (“GDPR”) governs the processing of personal data.

The GDPR imposes a broad range of strict requirements on companies subject to the GDPR, such as including requirements relating to having legal basis for processing personal data relating to identifiable individuals and transferring such information outside the European Economic Area (“EEA”), including to the U.S., providing details to those individuals regarding the processing of their personal data, implementing safeguards to keep personal data secure, having data processing agreements with third parties who process personal data in countries not deemed adequate by the EU and UK, responding to individuals’ requests to exercise their rights in respect of their personal data, obtaining consent of the individuals to whom the personal data relates if there is no legal basis for processing, reporting security and privacy breaches involving personal data to the competent national data protection authority and affected individuals, appointing data protection officers, conducting data protection impact assessments, and record-keeping.

The GDPR imposes a broad range of strict requirements on companies subject to the GDPR, such as including requirements relating to having legal basis for processing personal data relating to identifiable individuals and transferring such information outside the European Economic Area (“EEA”), including to the U.S., providing details to those individuals regarding the processing of their personal data, implementing safeguards to keep personal data secure, having data processing agreements with third parties who process personal data in countries not deemed adequate by the EU and the UK, responding to individuals’ requests to exercise their rights in respect of their personal data, obtaining consent of the individuals to whom the personal data relates if there is no legal basis for processing, reporting security and privacy breaches involving personal data to the competent national data protection authority and affected individuals, appointing data protection officers, conducting data protection impact assessments, and record-keeping.

The GDPR substantially increases the penalties to which we could be subject in the event of any non-compliance, including fines of up to €20,000,000 or 4% of total annual global revenue, whichever is greater.

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The UK government has confirmed that personal data transfers from the UK to the EEA remain free flowing.

We will be required to implement certain safeguards detailed in these regulations when conducting restricted data transfers under the EU and UK GDPR and doing so will require significant effort and cost.

We are required to implement certain safeguards detailed in these regulations when conducting restricted data transfers under the EU and UK GDPR and regulators retain authority to further restrict or prohibit transfers to certain countries where applicable laws would undermine the privacy safeguards provided by the GDPR.

PRC Regulation

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A foreign MAH is required to engage a local agent to fulfill the MAH’s obligations and the foreign MAH is subject to joint and several liability in the event of any wrongdoing.

On November 13, 2024, the NMPA issued the Interim Provisions for the Management of Domestic Responsible Persons Designated by Foreign Drug Marketing Authorization Holders (the “Interim Provisions”), which will come into effect on July 1, 2025.

The Interim Provisions explicitly require foreign MAHs to designate local delegates and authorize them to undertake important post-marketing responsibilities together with the drug MAHs, including post-marketing change management, pharmacovigilance, and product quality complaint handling.

As of July 1, 2025, the name, address and contact information of the domestic responsible person shall be listed in the package insert and detailed requirements of implementation shall be subject to further practical guidance and interpretation rules from the relevant government authorities.

The DAL requires drug manufacturers and drug distributors to comply with current GMP and GSP requirements.

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Category 1 (innovative drugs) refers to drugs that have a new chemical entity that has not been marketed anywhere in the world, Category 2 (improved new drugs) refers to drugs with a new indication, dosage form, route of administration, combination, or certain formulation changes not approved in the world, Categories 3 and 4 are for generics that reference an innovator drug (or certain well-known generic drugs) marketed either abroad or in China, respectively, and Category 5 refers to innovative or generic drugs that have already been marketed abroad but are not yet approved in China (i.e., imported drugs).

Therapeutic biologics follow a similar categorization, with Category 1 being new to the world.

Biosimilars are under Category 3.

Each of zanubrutinib, tislelizumab, pamiparib and lifirafenib is classified as Category 1 based on the defined registration Category by the NMPA.

Zanubrutinib, pamiparib and tislelizumab have been approved by the NMPA as Category 1 drugs.

Amgen’s BLINCYTO, XGEVA, and KYPROLIS, as well as EUSA’s QARZIBA and SYLVANT have all been approved by the NMPA as Category 1 drugs.

Expedited Programs

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Following approval, the MAH is required to take risk mitigation measures and complete a post-market study as required by the NMPA within a prescribed timeline.

BRUKINSA received conditional approval for the treatment of MCL in adult patients who have received at least one prior therapy, CLL or SLL in adult patients who have received at least one prior therapy (converted to regular approval), and for adult patients with WM who have received at least one prior therapy (converted to regular approval).

Tislelizumab received conditional approval as a treatment for patients with cHL who have received at least two prior therapies and as a treatment for patients with locally advanced or metastatic UC, a form of bladder cancer, with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, and for the treatment of patients with HCC who have been previously treated with at least one systemic therapy (converted to regular approval).

PARTRUVIX received conditional approval for the treatment of patients with gBRCA mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy.

XGEVA received conditional approval for the treatment of adults and skeletally mature adolescents with GCTB that is unresectable or where surgical resection is likely to result in severe morbidity (converted to regular approval) and for the prevention of SREs in patients with bone metastases from solid tumors and in patients with MM.

BLINCYTO received conditional approvals for the treatment of both adult and pediatric patients with R/R CD19-positive B-cell precursor acute lymphoblastic leukemia (adult indication converted to regular approval).

KYPROLIS received conditional approval for the treatment of adult patients with R/R multiple myeloma.

QARZIBA received conditional approval for high-risk neuroblastoma.

Breakthrough Therapy Designation

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Applicants of drugs designated as breakthrough therapies will be entitled to direct communications with CDE at key states during the clinical trials and may seek CDE’s opinion on study progress.

BRUKINSA as a treatment for adult patients with CLL/SLL was granted BTD in China.

ZW25 (zanidatamab) as a treatment for R/R HER2-expressing biliary tract cancer was granted BTD.

Policies on Expediting Approval of Imported Oncology Drugs

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Distributors and user entities (e.g., hospitals) are also required to report, in their respective roles, adverse reactions of the products they sell or use, and assist the MAH with any product recalls.

An MAH for a drug that is currently under the new drug monitoring period has to report all adverse drug reactions (as opposed to just serious adverse reactions) for that period.

A MAH for a drug that is currently under the new drug monitoring period has to report all adverse drug reactions (as opposed to just serious adverse reactions) for that period.

Advertising and Promotion of Pharmaceutical Products

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Regulatory Intellectual Property Protections

The amendments to the PRC Patent Law (the “Amended PRC Patent Law”) provides a cause of action to allow a patent holder to initiate a declarative action during the regulatory review process of a drug to determine whether the drug falls within the patent scope, which may be comparable to the patent linkage system in the U.S.

The system requires that the NMPA continue to review the potentially infringing follow-on application during any lawsuit by the innovator.

However, the NMPA may not approve the follow-on application pending resolution of the patent litigation in favor of the follow-on application or for a specified period of time, whichever is shorter.

The Amended PRC Patent Law also provides patent term extension, similar to the U.S., for the patent term lost during the regulatory review process of a new drug upon the patent holder’s request.

The extended term shall not exceed five years, and the total patent term after market entry of the new drug shall not exceed 14 years.

However, the provisions for patent term extension are unclear and/or remain subject to the approval of implementing regulations that are still in draft form, leading to uncertainty about the scope of implementation.

Additionally, the Innovation Opinion provided a foundation to improve and implement a system for regulatory data protection to protect innovative drugs.

This protection is available for undisclosed clinical trial data of drugs falling into the following categories:

innovative drugs, innovative therapeutic biologics, drugs that treat orphan diseases, pediatric drugs, and drugs for which there has been a successful patent challenge.

The NMPA has published draft regulations for public comment that would set regulatory data protection for innovative small molecule drugs at six years and for innovative therapeutic biologics at 12 years;

pediatric and orphan drugs would receive six years to run concurrently from their approval dates.

Full terms of protection would require reliance on local trials or sites of multi-center trials in China and simultaneous submissions of marketing applications in China and other countries.

Submissions in China that are up to six years later than those abroad would result in the term being reduced to 1-5 years.

Submissions over six years later in China may not receive protection.

The proposed regulations also call for a reduction in exclusivity if the marketing application is filed in China based solely on overseas clinical data with no Chinese subjects (75% reduction) or based on supplemental “China clinical trial data” (50% reduction).

Information about the exclusivity term will be included in a Marketed Drug List (similar to the Orange Book in the U.S.) at the time of approval.

Some mechanics of these proposed rules are not yet clear, and it is not certain when the proposed rules will be finalized.

The amendments to the PRC Patent Law (the “Amended PRC Patent Law”) provides a cause of action to allow a patent holder to initiate a declarative action during the regulatory review process of a generic drug application to determine whether the drug falls within the patent scope, which may be comparable to the patent linkage system in the U.S.

The system requires that the NMPA continue to review the potentially infringing generic application during any lawsuit by the innovator.

However, the NMPA may not approve the generic application pending resolution of the patent litigation in favor of the generic filer or for a specified period of time, whichever is shorter.

The Amended PRC Patent Law also provides patent term extension (“PTE”) for the patent term lost during the regulatory review process of a new drug upon the patent holder’s request.

The extended term shall not exceed five years, and the total patent term after approval of the drug shall not exceed 14 years.

On December 21, 2023, the final versions of Rules for Implementation of the Patent Law was published, and the China National Intellectual Property Administration (“CNIPA”) published new version of Patent Examination Guidelines accordingly.

The Implementation Rules and Patent Examination Guidelines introduced detailed rules and examination guidelines on PTE, and took effect on January 20, 2024.

Reimbursement and Pricing

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KYPROLIS has been included in the NRDL since 2022.

SYLVANT and BAITUOWEI were included in the NRDL in December 2023, which took effect on January 1, 2024.

SYLVANT and BAITUOWEI have been included in the NRDL since 2024.

Centralized Procurement and Tenders

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Clinical effects, adverse reactions, and batch stability of the drugs will be considered, and their consistency will be the main criteria for evaluation, while production capacity and stability of the supplier will also be considered.

In recent years, China has gradually improved its mechanism for centralized medicine procurement.

On November 18, 2024, the NHSA together with the NHC jointly issued Notice on Improving Working Mechanism of Centralized Drug Procurement and Implementation.

The new notice sets forth ten improvements to strengthen the management of the whole process of centralized drug procurement based upon existing policies.

Other PRC National and Provincial Laws and Regulations

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Pursuant to the 2022 Encouraged Industry Catalogue, the research, development and manufacture of innovative oncology drugs, cell therapies, and certain other types of pharmaceutical products belongs to the encouraged industries for foreign investment.

In September 2024, the Ministry of Commerce, the National Health Commission and the National Medical Products Administration jointly issued the Notice on Carrying out a Pilot Program for Expanding Opening-up in the Medical-related Field, which further allows foreign invested enterprises to engage in the technology development and application of human stem cell, gene diagnosis and treatment in four designated pilot free trade zones of China for the registration, marketing and production of products, and allow the establishment of wholly foreign-owned hospitals in selected cities and regions, which will further optimize foreign investment environment and attract foreign investment to propel the high-quality development of healthcare sector in China.

PRC Antitrust Regulation

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The SAMR is the chief regulator of anti-trust law in China, and the pharmaceutical sector has been one of its focused enforcement area for years.

For example, in 2021, a local drug company was found to have engaged in resale price maintenance (“RPM”) practices and fined up to RMB 764 million, and in 2023, another local drug company was also fined RMB 12.64 million for RPM.

For example, in 2021, a local drug company was found to have engaged in resale price maintenance (“RPM”) practices and fined up to RMB 764 million, and in 2023, SAMR announced seven administrative penalty decisions on monopoly agreement reached and/or abuse of market dominance in pharmaceutical industry, among which, a local drug company was fined RMB 12.64 million for RPM.

Regulations Relating to Product Liability

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directly or indirectly for payment beyond the business scope of the enterprises or the payment prohibited by relevant laws and regulations;

directly or indirectly for investment in securities, unless otherwise provided by relevant laws and regulations;

extending loans to non-related parties, unless permitted by the scope of business;

or paying expenses related to the purchase of real estate that is not for self-use, except for real estate enterprises.

directly or indirectly for investment in securities or certain other financial products, unless otherwise provided by relevant laws and regulations;

extending loans to non-related parties, unless permitted by the scope of business and located in the designated area;

or paying expenses related to the purchase of residential real estate that is not for self-use, except for real estate enterprises.

Regulations have relaxed the restrictions on foreign exchange inflow to further enhance trade and investment facilitation and enhance genuineness and compliance verification of cross-border transactions and cross-border capital flows.

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For other countries outside of the U.S.

and the PRC, the requirements governing the conduct of clinical trials, drug licensing, pricing and reimbursement, and other matters impacting our business vary from country to country.

and the PRC, the requirements governing the conduct of preclinical studies, clinical trials, drug licensing, manufacturing, pricing and reimbursement, and other matters impacting our business vary from country to country.

In all cases, clinical trials must be conducted in accordance with GCP requirements, applicable regulatory requirements, and the ethical principles having their origin in the Declaration of Helsinki.

Status under Holding Foreign Companies Accountable Act

In December 2021, the SEC adopted rules (the “Final Rules”) to implement the Holding Foreign Companies Accountable Act (the “HFCAA”).

The HFCAA includes requirements for the SEC to identify issuers who file annual reports with audit reports issued by independent registered public accounting firms located in foreign jurisdictions that the Public Company Accounting Oversight Board (“PCAOB”) is unable to inspect or investigate completely because of a position taken by a non-U.S.

The Holding Foreign Companies Accountable Act (as amended, the “HFCAA”) includes requirements for the SEC to identify issuers who file annual reports with audit reports issued by independent registered public accounting firms located in foreign jurisdictions that the Public Company Accounting Oversight Board (“PCAOB”) is unable to inspect or investigate completely because of a position taken by a non-U.S.

authority in the accounting firm’s jurisdiction (“Commission-Identified Issuers”).

The HFCAA also requires that, to the extent that the PCAOB has been unable to inspect an issuer’s independent registered public accounting firm for three consecutive years since 2021, the SEC shall prohibit the issuer’s securities registered in the U.S.

The HFCAA also requires that, to the extent that the PCAOB has been unable to inspect an issuer’s independent registered public accounting firm for two consecutive years since 2021, the SEC shall prohibit the issuer’s securities registered in the U.S.

from being traded on any national securities exchange or over-the-counter markets in the U.S.

In December 2022, the Accelerating Holding Foreign Companies Accountable Act amended the HFCAA to shorten the three-year period to two years.

Under the Final Rules, the SEC adopted submission and disclosure requirements by amending Form 10-K and other annual reporting forms and established procedures to identify issuers and prohibit the trading of the securities of certain registrants as required by the HFCAA.

Specifically, the Final Rules require each Commission-Identified Issuer to submit documentation to the SEC annually on or before its annual report due date that establishes that it is not owned or controlled by a government entity in its public accounting firm’s foreign jurisdiction and require additional specified disclosures by “foreign issuers” as defined in Rule 3b-4 promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

The SEC identifies an issuer as a Commission-Identified Issuer after the issuer files its annual report and on a rolling basis, and will impose an initial trading prohibition on an issuer as soon as practicable after it has been conclusively identified as a Commission-Identified Issuer for two consecutive years.

To make that certification, the Commission-Identified Issuer must file financial statements that include an audit report signed by such a registered public accounting firm.

On March 30, 2022, as expected following its adoption of the Final Rules, the SEC added BeiGene, Ltd.

to its conclusive list of issuers identified under the HFCAA, after being provisionally named as a Commission-Identified Issuer on March 8, 2022, following the filing of its annual report on Form 10-K with the SEC on February 28, 2022.

Under the HFCAA, each Commission-Identified Issuer is required to submit documentation to the SEC annually on or before its annual report due date that establishes that it is not owned or controlled by a government entity in its public accounting firm’s foreign jurisdiction and require additional specified disclosures by “foreign issuers” as defined in Rule 3b-4 promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

The SEC identifies an issuer as a Commission-Identified Issuer after the issuer files its annual report and on a rolling basis.

To end an initial or subsequent trading prohibition, a Commission-Identified Issuer must certify that it has retained a registered public accounting firm that the PCAOB has determined it is able to inspect or investigate by filing financial statements that include an audit report signed by such a registered public accounting firm.

On March 30, 2022, the SEC added BeiGene, Ltd.

to its conclusive list of issuers identified under the HFCAA.

Ernst & Young Hua Ming LLP, located in the PRC, served as our independent registered public accounting firm from 2014 to 2021, including for our annual report on Form 10-K for the year ended December 31, 2021.

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On the same day, our audit committee approved the engagement of Ernst & Young LLP (U.S.) as the Company’s independent registered public accounting firm for the audits of our financial statements and internal control over financial reporting for the fiscal year ending December 31, 2022.

Ernst & Young LLP (U.S.) has continued to serve as our independent registered public accounting firm for the fiscal year ending December 31, 2023.

No changes were made to the accounting firms who audit our financial statements filed with the Shanghai Stock Exchange and the Hong Kong Stock Exchange, which will remain Ernst & Young Hua Ming LLP, located in Beijing, PRC, and Ernst & Young, located in Hong Kong, PRC, respectively.

In August 2022, the PCAOB signed a Statement of Protocol with the CSRC and the Ministry of Finance of the People’s Republic of China, taking the first step toward opening access for the PCAOB to inspect and investigate registered public accounting firms headquartered in mainland China and Hong Kong.

PCAOB staff members conducted on-site inspections and investigations from September to November 2022, and in December 2022, the PCAOB announced that it has secured complete access to inspect and investigate registered public accounting firms headquartered in mainland China and Hong Kong and confirmed that until such time as the PCAOB issues any new determination, there are no Commission-Identified Issuers at risk of having their securities subject to a trading prohibition under the HFCAA.

Given that Ernst & Young LLP (U.S.) has served as the principal accountant to audit our consolidated financial statements to be filed with the SEC since 2022, we believe we are compliant with the HFCAA, which should preclude a further finding by the SEC that we are a Commission-Identified Issuer and therefore the delisting of our American Depositary Shares from NASDAQ.

Ernst & Young LLP (U.S.) has continued to serve as our independent registered public accounting firm for the fiscal year ending December 31, 2023 and those thereafter.

No changes were made to the accounting firms who audit our financial statements filed with the Shanghai Stock Exchange and the Hong Kong Stock Exchange, which remain Ernst & Young Hua Ming LLP, located in Beijing, PRC, and Ernst & Young, located in Hong Kong, PRC, respectively.

In December 2022, the PCAOB announced that it has secured complete access to inspect and investigate registered public accounting firms headquartered in mainland China and Hong Kong and confirmed that until such time as the PCAOB issues any new determination, there are no Commission-Identified Issuers at risk of having their securities subject to a trading prohibition under the HFCAA.

Given that Ernst & Young LLP (U.S.) has served as the principal accountant to audit our consolidated financial statements to be filed with the SEC since 2022, we believe this should preclude the delisting of our American Depositary Shares from Nasdaq under HFCAA.

For a detailed description of risks related to our doing business in China and status under the HFCAA, see “Item 1A.

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For example, in July 2021, the relevant PRC government authorities made public the Opinions on Intensifying Crack-Down on Illegal Securities Activities (the “Securities Opinions”) which emphasized the need to strengthen the administration over illegal securities activities and the supervision on overseas listings by China-based companies and proposed to take measures, such as promoting the construction of relevant regulatory systems to deal with the risks and incidents faced by China-based overseas-listed companies.

In November 2021, the Cyberspace Administration of China (the “CAC”) released the draft Administrative Regulations on Cyber Data Security for public comments, which requires, among others, that a prior cybersecurity review should be required for listing abroad of data processors which process over one million users’ personal information, and the listing of data processors in Hong Kong which affects or may affect national security.

In September 2024, the State Council released the Administrative Regulations on Cyber Data Security, which require, among others, a prior cybersecurity review for cyber data processing activities which affect or may affect national security.

In March 2023, the Overseas Listing Trial Measures, and five relevant guidelines issued by the CSRC took effect, requiring the Chinese domestic companies’ overseas offerings and listings of equity securities be filed with the CSRC.

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Risk Factors—Risks Related to Our Doing Business in the PRC.”

Flow of Funds with our PRC Operations

We are a holding company incorporated in the Cayman Islands with operations primarily conducted through direct and indirect subsidiaries in the U.S., China, United Kingdom, Switzerland and Australia.

Flow of Funds with our Operations including the PRC

We are a holding company incorporated in the Cayman Islands with operations primarily conducted through direct and indirect subsidiaries in the U.S., China, the UK, Switzerland and Australia.

The intercompany flow of funds within the organization is effected through capital contributions, intercompany loans, intercompany transfers of products and intellectual property, and cost reimbursements.

Since our formation in 2010, BeiGene, Ltd.

has raised over $10.0 billion in various public and private stock offerings as of December 31, 2023.

Of this amount, $1.9 billion and RMB 17.1 billion have been transferred as capital contributions to its operating subsidiaries.

As of December 31, 2023, BeiGene Ltd.

had intercompany loans outstanding of $1.6 billion and RMB 340 million to its operating subsidiaries.

BeiGene, Ltd., by itself or through its affiliates, is also the holder or licensee and developer of biopharmaceutical patents.

Certain of these patents have been transferred to operating subsidiaries for further development and commercialization.

Since formation in 2010, BeiGene, Ltd.

has raised over $10.8 billion in various public and private stock offerings and from various borrowings.

Of this amount, (1) $2.1 billion and RMB18.9 billion have been transferred as capital contributions to its operating subsidiaries and (2) $1.5 billion and RMB1.9 billion are outstanding intercompany loans due from its operating subsidiaries as of December 31, 2024.

All biopharmaceutical patents previously owned by BeiGene, Ltd.

have been transferred to operating subsidiaries for further development and commercialization.

As of December 31, 2024, BeiGene, Ltd.

held $3.2 billion in cash, cash equivalents and short-term investments which are available for future investment in its programs and in our operating subsidiaries.

To date, BeiGene, Ltd.

held $400 million in cash and cash equivalents which are available for future investment in its programs and operating subsidiaries, of which $216 million is to be used in China pursuant to the obligations under the Company’s offering on the STAR Market.

The Company’s subsidiaries outside of China have cash and cash equivalents of $1.1 billion that may be permanently transferred to BeiGene, Ltd.

in the form of dividends and distributions or temporarily in the form of intercompany loans or advances without consent of a third-party;

however, to date, BeiGene, Ltd.

has not received any dividends or distributions from its operating subsidiaries.

As of December 31, 2024, the Company has established a deferred tax liability of $24 million associated with potential withholding taxes in the U.S.

and Canada on unremitted earnings that are no longer indefinitely reinvested.

The amount of actual cash taxes associated with potential future distributions will depend on the timing of cash outflows at the parent and availability and use of cash in other jurisdictions that are not subject to withholding taxes.

Please see the section of this Annual Report titled “Liquidity and Capital Resources” for further discussion.

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In addition, PRC regulations currently permit payment of dividends of a PRC company only out of accumulated distributable after-tax profits, as determined in accordance with our articles of association and the accounting standards and regulations in the PRC.

We may rely on dividends and other distributions on equity paid by our PRC subsidiaries for our cash and financing requirements, including the funds necessary to pay dividends and other cash distributions to our shareholders or to service any debt we may incur.

If any of our PRC subsidiaries incur debt on their own behalf in the future, the instruments governing the debt may restrict their ability to pay dividends or make other distributions to us.

We may rely on dividends and other distributions on equity paid by our PRC subsidiaries or as noted above on dividends and distributions from our U.S, Canadian and other subsidiaries for our cash and financing requirements, including the funds necessary to pay dividends and other cash distributions to our shareholders or to service any debt we may incur.

If any of our PRC subsidiaries incur debt on their own behalf in the future, the instruments governing the debt may restrict their ability to pay dividends or make other distributions to us from those subsidiaries in the PRC but not from our subsidiaries in the U.S., Canada and others.

Under PRC laws and regulations, our PRC subsidiaries may pay dividends only out of their respective accumulated profits as determined in accordance with PRC accounting standards and regulations.

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As a result, any restriction on currency exchange may limit the ability of our PRC subsidiaries to use their RMB revenues to pay dividends to us.

However, conversion of RMB to other currencies are permitted for the purpose of dividends according to the PRC’s regulations on foreign exchange administration.

Notwithstanding the foregoing, any limitation on the ability of our PRC subsidiaries to pay dividends or make other kinds of payments to us could materially and adversely limit our ability to grow, make investments or acquisitions that could be beneficial to our business, pay dividends, or otherwise fund and conduct our business.

However, conversion of RMB to other currencies are permitted for the purpose of dividends according to the PRC’s regulations on foreign exchange control.

The PRC government may, in accordance with applicable laws and regulations, impose limitations on access to foreign currencies for current account transactions and if this occurs in the future, we may not be able to pay dividends in foreign currencies to our shareholders.

Any limitation on the ability of our PRC subsidiaries to pay dividends or make other kinds of payments to us could materially and adversely limit our ability to grow, make investments or acquisitions that could be beneficial to our business, pay dividends, or otherwise fund and conduct our business.

As a result, and principally due to the restriction in China, our subsidiaries’ restricted net assets (as defined in Rule 5-04 of Regulation S-X) exceeds 25% of our consolidated net assets and thus we have provided the stand-alone financial statements of BeiGene, Ltd.

in Item 15 as Schedule 1.

The PRC Enterprise Income Tax Law and its implementation rules provide that China-sourced income of foreign enterprises, such as dividends paid by a PRC subsidiary to its equity holders that are non-PRC resident enterprises, will normally be subject to PRC withholding tax at a rate of 10%, unless any such foreign investor’s jurisdiction of incorporation has a tax treaty with China that provides for a reduced withholding rate arrangement and such non-PRC resident enterprises constitute the beneficiary of such income.

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BeiGene HK currently does not hold a Hong Kong tax resident certificate from the Inland Revenue Department of Hong Kong, and there is no assurance that the reduced withholding tax rate will be available.

Permissions Required from the PRC Authorities for Our Operations

Permissions Required from the PRC Authorities for Our Operations and Securities Offerings

We conduct our business in the PRC through our PRC subsidiaries.

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As of the date of this Annual Report, we do not operate our businesses in China or elsewhere through variable interest entities, or VIEs, and therefore are not subject to risks associated with contractual arrangements with VIEs.

As of the date of this annual report, we have not received any inquiry, notice, warning, or sanctions regarding our business operations and corporate structure from the CSRC, CAC or any other PRC governmental agency that would have a material impact on our business, results of operations or financial condition.

As of the date of this annual report, we have not received any inquiry, notice, warning, or sanctions regarding our business operations and corporate structure from the CSRC, the Cyberspace Administration of China (the “CAC”), or any other PRC governmental agency that would have a material impact on our business, results of operations or financial condition.

However, given the uncertainties of interpretation and implementation of relevant laws and regulations and the enforcement practice by government authorities, we cannot assure you that we have obtained all permits or licenses required for conducting our business in the PRC.

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In connection with our previous issuance of securities to foreign investors in stock markets outside the PRC, under current PRC laws, regulations and regulatory rules, as of the date of this Annual Report, we and our PRC subsidiaries, (i) are not required to obtain permissions from the CSRC, (ii) are not required to go through cybersecurity review by the Cyberspace Administration of China, or the CAC, and (iii) have not received or were denied such requisite permissions by any PRC authority.

On February 17, 2023, the CSRC released the Overseas Listing Trial Measures and five relevant guidelines, which took effect March 31, 2023.

In 2023, the CSRC released the Overseas Listing Trial Measures and five relevant guidelines.

The Overseas Listing Trial Measures require the Chinese domestic companies’ overseas offerings and listings of equity shares, depositary receipts, convertible bonds, preferred shares or other equity securities be filed with the CSRC.

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As of the date of this Annual Report, we have not received any inquiry, notice, warning or sanction regarding obtaining approval, completing filing or other procedures in connection with offering our equity securities in overseas stock markets from the CSRC or any other PRC governmental or regulatory authorities that have jurisdiction over our operations.

However, there remains significant uncertainty as to the interpretation and implementation of regulatory requirements related to overseas securities offerings and other capital markets activities, including the Overseas Listing Trial Measures.

Although we intend to fully comply with the then effective relevant laws and regulations applicable to any securities offerings we may conduct, there are uncertainties with respect to whether we will be able to fully comply with requirements to obtain any permissions and approvals from, or complete any reporting or filing procedures with, PRC authorities that may be in effect in the future.

If we, for any reason, are unable to complete, or experience significant delays in completing the requisite filing or other procedure(s), we may face sanctions by the CSRC or other Chinese regulatory authorities as applicable.

These regulatory authorities may impose fines and penalties on our operations in the PRC, limit our ability to pay dividends outside of China, limit our operations in the PRC, delay or restrict the repatriation of funds into the PRC or take other actions that could have a material adverse effect on our business, financial condition, results of operations and prospects, as well as the trading price of our ADSs, ordinary shares and RMB Shares.

Cash Management Policies and Procedures

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and its subsidiaries hold cash in demand deposits, time deposits and money market funds for the operating needs of each entity, including from intercompany transactions.

As needed, cash to fund both short-term operating needs (such as investments in inventory or sales marketing capabilities) and long-term investment needs (such as for property, plant and equipment) can be transferred from BeiGene Ltd.

As needed, cash to fund both short-term operating needs (such as investments in inventory or sales and marketing capabilities) and long-term investment needs (such as for property, plant and equipment) can be transferred from BeiGene, Ltd.

or between subsidiaries to supply additional liquidity using capital contributions, intercompany advances or loans, as follows:

• Cash may be transferred between BeiGene HK and its operating subsidiaries in mainland China through intercompany loans and capital contributions.

Cash generated from BeiGene HK is used to fund operations of its subsidiaries, and no funds were transferred from BeiGene HK’s subsidiaries in mainland China to fund operations of other BeiGene subsidiaries outside of mainland China for the year ended on December 31, 2022 and December 31, 2023.

For the year ended December 31, 2022 and December 31, 2023, the amount of cash transferred between BeiGene HK and its subsidiaries in mainland China was $351 million and $295 million, respectively.

For the years ended December 31, 2024 and 2023, the amount of cash transferred between BeiGene HK and its subsidiaries in mainland China was $106 million and $295 million, respectively.

• Cash may be transferred between BeiGene UK, Ltd.

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There are currently no restrictions on transferring funds between BeiGene UK or BeiGene Switzerland and their respective operating subsidiaries.

Cash generated from BeiGene UK and BeiGene Switzerland may be used to fund operations of their respective subsidiaries, and no funds were transferred from BeiGene UK’s subsidiaries or from BeiGene Switzerland’s subsidiaries to fund operations of other BeiGene subsidiaries (such as BeiGene HK and its subsidiaries in mainland China) for the year ended December 31, 2022 and December 31, 2023.

For the year ended December 31, 2022 and December 31, 2023, the amount of cash transferred between BeiGene UK to its respective subsidiaries was $4 million and $270 million, respectively.

For the years ended December 31, 2022 and December 31, 2023, the amount of cash transferred between BeiGene Switzerland to its respective subsidiaries was $65 million and nil, respectively.

For the years ended December 31, 2024 and 2023, the amount of cash transferred between BeiGene UK to its respective subsidiaries was $142 million and $270 million, respectively.

For the years ended December 31, 2024 and 2023, the amount of cash transferred between BeiGene Switzerland to its respective subsidiaries was nil.

Human Capital Resources

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In addition to base salaries, these programs include potential annual discretionary bonuses, equity awards, a 401(k) plan in the U.S.

and pension plans in other jurisdictions, healthcare and insurance benefits, health savings and flexible spending accounts, paid time off, family leave, and flexible work schedules, among others.

and pension plans in other jurisdictions, healthcare and insurance benefits, health savings, life and disability insurances, and flexible spending accounts, paid time off, family leave, and flexible work schedules, among others.

In addition to our broad-based equity award programs, we have used equity-based grants with vesting conditions to facilitate retention of key personnel.

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Our management team routinely makes themselves available to all employees, including in regular town hall events that encourage open dialogue.

Fostering a culture of accountability and compliance is also important, and all of our employees complete trainings on applicable corporate policies including our Global Code of Conduct;

Fostering a culture of accountability and compliance is also important, and all of our employees complete trainings on applicable corporate policies including our Global Code of Conduct which covers conflicts of interest;

Harassment, Discrimination, and Retaliation Policy;

Conflicts of Interest Policy;

Insider Trading Policy;

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Bold Ingenuity, Collaborative Spirit, Driving Excellence, and most importantly, Patients First.

As a global entity with many remote workers, we have been able to build a diverse team of talented professionals, regardless of their location.

As a global organization, we are comprised of employees at various life stages, of multiple backgrounds, and from diverse cultures, where everyone can share their ideas and perspectives.

We celebrate our differences and value diversity and inclusion in the workplace.

We believe that diversity of backgrounds and ideas inspire creativity and help us create the innovative medicines patients need.

We are proud to be an equal opportunity employer.

BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by applicable law.

As a global entity with many remote workers, we have been able to build a team of talented professionals with a wide range of experiences, regardless of their location.

We are an equal opportunity employer.

We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, physical or mental disability, national origin, veteran status or any other basis covered by applicable law.

All employment is decided on the basis of qualifications, merit, and business need.

Further, we have policies in place that prohibit harassment of all kinds.

We maintain an inclusive culture where all voices are welcomed, heard, and respected.

As of February 14, 2024, we had approximately 10,600 full-time employees worldwide, across five continents, with approximately 1,600 employees in the U.S.

Further, we have policies in place that prohibit harassment and retaliation and a 24/7 ethics hotline where concerns can be raised on an anonymous basis.

We maintain a culture where all voices are welcomed, heard, and respected.

As of February 14, 2025, we had over 11,000 full-time employees worldwide, across six continents, with approximately 1,700 employees in the U.S.

and the balance outside of the U.S.

We have also engaged and may continue to engage independent contractors to assist us with our operations.

None of our employees are represented by a labor union or covered by a collective bargaining agreement, except as required by local laws such as in some European countries.

We have never experienced any employment-related work stoppages, we also track voluntary and involuntary turnover rates and we consider our relations with our employees to be good.

Responsible Business & Sustainability Strategy

In 2022, we announced our global strategy, Change Is the Cure , which guides our efforts across five focus areas:

advancing global health, empowering our people, innovating sustainably, supporting communities, and operating responsibly.

Within each focus area, we have identified key strategic priorities against which we have set concrete targets.

We report our progress against our targets in late April of each year.

While we are at the start of our journey, we are proud of the progress we have made to date.

We joined the United Nations Global Compact in 2022 and have aligned our efforts with UN Sustainable Development Goals.

We know that access to oncology treatments lags in many parts of the world, particularly in low-income countries.

To help close this health equity gap, BeiGene became a founding member of the Union for International Cancer Control’s Access to Oncology Medicines Coalition which focuses on improving access to innovative medicines in lower-income countries and supporting them in developing the capacity to provide proper treatment for patients.

In 2023, we also announced a collaboration with the Max Foundation, a global nonprofit organization dedicated to accelerating health equity by delivering medication, technology, and supportive services to patients worldwide, BeiGene, and the BeiGene Foundation, a nonprofit charitable foundation, to provide access to BRUKINSA for the treatment of adult patients with CLL in 29 low- and middle-income countries over the next three years.

This collaboration advances each organization’s focus on patient access by combining the Max Foundation’s expertise and infrastructure with a donated product from BeiGene, and a grant from the BeiGene Foundation.

We believe that our people are critical to our success and, as a global company, we know that sharing diverse ideas and perspectives spurs greater innovation and enhances our ability to deliver results.

Our culture celebrates and encourages the voices of all our employees and promotes a respectful, collaborative environment.

Our Diversity, Equity, Inclusion & Belonging strategy, Belong@BeiGene, is centered on bringing diverse voices to the forefront of our work and embedding inclusion in all aspects of BeiGene’s operations.

Our strategy encompasses three areas:

Workforce (our people), Workplace (our culture) and Marketplace (our communities).

In 2020, we formed the Inclusion, Diversity, Equity, and Awareness (“IDEA”) Council to provide a forum for U.S.

employees to explore issues of diversity, equity, inclusion, and belonging.

Introduced first in the U.S., the IDEA Council is now global, with members in geographies including Canada, Europe, China, and Australia.

In 2022, we completed a three-year diversity, equity, inclusion and belonging strategy, and in 2023, an Executive Director, Diversity and Global Health Equity was brought on board to lead our effort in this area.

In addition to directly supporting patients through the delivery of cutting-edge therapies, we strive to support the communities in which we live and work.

In 2023, the BeiGene Foundation was established as an independent 501(c)(3) organization to provide grants to charitable organizations aligned with the Foundation’s mission.

Related to volunteerism, we expanded our employee volunteer paid time-off policy to colleagues worldwide and in July 2023, Be the Change, a global employee volunteer platform, was officially launched.

This platform enables colleagues to learn about local and national community partnerships, create or register for volunteer opportunities, and record volunteer hours.

More details about our Responsible Business & Sustainability strategy, goals and progress to date will be available in our 2023 Responsible Business & Sustainability Report, which will be published in late April 2024.

Our previous progress reports can be found on our corporate website at www.beigene.com.

We have also engaged and may continue to engage contingent workers to assist us with our operations.

None of our employees are represented by a labor union or covered by a collective bargaining agreement, except as required by local laws such as in some European countries and Brazil.

We also track voluntary and involuntary turnover rates and we consider our relations with our employees to be good.

Responsible Business & Sustainability

As a global organization focused on providing innovative medicines to more patients around the world, our Responsible Business & Sustainability (“RB&S”) efforts are aligned with our corporate strategy.

broad patient access and sustainable profitability are achievable through cost and speed efficiencies in drug discovery and development;

the discovery of novel solutions is enabled by engaged colleagues with varied experiences and perspectives and an inclusive culture;

and operational resilience is supported by our efforts to identify and mitigate risk in our operations and in our value chain.

As such, our RB&S strategy is focused on the following key areas:

Advancing Global Health - We are focused on developing impactful medicines that will be accessible to far more patients around the world.

Empowering Our Colleagues - We are committed to fostering a culture of innovation and building a global workforce that enables our colleagues to thrive.

Innovating Sustainably - We aim to assess and mitigate our impact on the environment and ensure business continuity.

Operating Responsibly - We operate with integrity, transparency, and discipline to ensure we are meeting the expectations of our stakeholders.

Within each focus area, we have identified key strategic priorities against which we have set targets.

Our targets are aspirational and may change;

statements regarding these priorities and targets are not guarantees or promises that they will be met.

We report our progress in late April of each year, and our reports can be found on our corporate website.

Financial Information

The financial information required under this Item 1 is incorporated herein by reference to the section of this Annual Report titled “Part II-Item 8-Financial Statements and Supplementary Data.” For financial information regarding our business, please see the section of this Annual Report titled “Part II-Item 7-Management’s Discussion and Analysis of Financial Condition and Results of Operations” of this Annual Report and our consolidated audited financial statements and related notes included elsewhere in this Annual Report.

The financial information required under this Item 1 is incorporated herein by reference from the section of this Annual Report titled “Part II-Item 8-Financial Statements and Supplementary Data.” For financial information regarding our business, please see the section of this Annual Report titled “Part II-Item 7-Management’s Discussion and Analysis of Financial Condition and Results of Operations” of this Annual Report and our consolidated audited financial statements and related notes included elsewhere in this Annual Report.

Corporate Information

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Available Information

We make available on or through our website certain reports and amendments to those reports that we file with or furnish to the SEC, in accordance with the Exchange Act.

We make available on or through the Investor section of our website certain reports and amendments to those reports that we file with or furnish to the SEC, in accordance with the Exchange Act.

These include our annual reports on Form 10-K, our quarterly reports on Form 10-Q, and our current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act.

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We make this information available on or through our website free of charge as soon as reasonably practicable after we electronically file the information with, or furnish it to, the SEC, the HKEx, and the SSE.

We use our website as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD.

From time to time, we may use the Investors section of our website at www.beigene.com , our X (formerly known as Twitter) account at x.com/BeiGeneGlobal , our LinkedIn account at linkedin.com/company/BeiGene, our Facebook account at facebook.com/BeiGeneGlobal, and our Instagram account at instagram.com/BeiGeneGlobal to disclose material information and to comply with our disclosure obligations under Regulation FD.

Investors are encouraged to review the Investors section of our website because we may post material information on that site that is not otherwise disseminated by us.

Information that is contained in and can be accessed through our website, our X posts, our LinkedIn posts and our Instagram posts are not incorporated into, and does not form a part of, this Annual Report.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business