What changed in this filing

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Item 1. Business

2026-02-26 compared with 2025-02-27 · 626 added, 494 removed, 910 unchanged (55% of the section changed)

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.

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

In 2025, we generated total global revenue of approximately $5.3 billion, increasing revenue by approximately 40.2% from the prior year, while achieving net income of $286.9 million, net cash provided by operating activities of $1.1 billion and positive free cash flow of $941.7 million.

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

We are the only company with potentially best-in-class assets across three foundational chronic lymphocytic leukemia (“CLL”) mechanisms of action (“MoAs”).

This includes BRUKINSA ® , a proven best-in-class Bruton’s tyrosine kinase (“BTK”) inhibitor, sonrotoclax, a next-generation and potentially best-in-class B-cell lymphoma 2 (“BCL2”) inhibitor that received its first global regulatory approval in December 2025, and our potentially first-in-class and best-in-class BTK chimeric degradation activation compound (“BTK-CDAC”).

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 is the only BTK inhibitor to prove superior efficacy to ibrutinib, especially over the long term.

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.

Despite being the third entrant to the market, BRUKINSA became the global market leader across B-cell malignancies in 2025.

BRUKINSA generated $3.9 billion in sales in 2025, is approved in over 75 markets and has launched in many key markets, including Europe, Japan, Korea and Brazil.

Our Phase 3 MANGROVE trial is evaluating BRUKINSA plus rituximab compared with bendamustine plus rituximab in previously untreated MCL.

Pending approval, this would be the first chemo-free regimen available for patients as a first line (“1L”) treatment for MCL.

Sonrotoclax is a potentially best-in-class BCL2 inhibitor designed to have greater potency and selectivity, and potential for better tolerability than venetoclax.

In late 2025, we received the first approval for sonrotoclax for adult patients with R/R MCL and CLL/small lymphocytic lymphoma (“SLL”) patients who have received prior systemic therapy, including a BTK inhibitor.

The approval, granted in China, is supported by data demonstrating deep and durable responses and manageable tolerability, underscoring sonrotoclax’s emerging role as a foundational medicine across B-cell malignancies.

Presented at the American Society of Hematology (“ASH”) meeting in 2025, monotherapy data from the Phase 1/2 study of patients with R/R MCL treated with sonrotoclax demonstrated a favorable safety and efficacy profile.

Sonrotoclax is under Priority Review by the U.S.

Food and Drug Administration (“FDA”) for potential accelerated approval in the first half of 2026.

Pending approval, sonrotoclax would be the first and only BCL2 inhibitor approved for monotherapy use in R/R MCL.

In the fixed dose BRUKINSA plus sonrotoclax combination, we presented unmatched levels and time to achieve undetectable minimal residual disease (“uMRD”), demonstrating a clear advantage over other fixed duration regimens.

The Phase 3 CELESTIAL-TNCLL trial of BRUKINSA plus sonrotoclax in 1L CLL has completed enrollment, and we have initiated a Phase 3 study in the first half of 2026, comparing BRUKINSA plus sonrotoclax against acalabrutinib plus venetoclax in 1L CLL.

Our BTK-CDAC, BGB-16673, 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 best-in-class potential and is the most advanced BTK degrader in development.

Data presented at ASH 2025 showed significant efficacy signals and safety data in a heavily pretreated population.

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

An accelerated approval filing submission based on the Phase 2 trial in R/R CLL could be made to the FDA in 2026 if data supports such submission.

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

We have a deep and innovative solid tumor pipeline.

In 2025, we advanced five differentiated new molecular entities (“NMEs”) into the clinic, each of which has the potential to be first-in-class or best-in-class.

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

Five solid tumor programs achieved proof of concept in 2025, including our next-generation cyclin-dependent kinase 4 (“CDK4”) inhibitor (BGB-43395) and potentially first-in-class B7-H4 antibody-drug conjugate (“ADC”) (BG-C9074), our differentiated MoA and first-in-class Glypican-3 (“GPC3”)-dependent 4-1BB targeting bispecific T-cell engager (BGB-B2033), our synergistic and potentially best-in-class protein arginine methyltransferase 5 (“PRMT5”) (BGB-58067), as well as our carcinoembryonic antigen (“CEA”) ADC (BG-C477).

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

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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.

Most importantly, our nearly 6,000 colleagues across clinical development and manufacturing across the globe allow 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 the highest quality.

Our global development “superhighway” is unique to BeOne and critical to generating superior returns on R&D investment.

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.

Since our inception in 2010, we have become a fully integrated global organization with nearly 12,000 employees worldwide.

Our Holding Company Structure

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.

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

In the second quarter of 2025, we redomiciled from the Cayman Islands to Switzerland.

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 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.

Our global development “superhighway” was uniquely built to address an increasingly challenged industry and improve R&D returns.

We have built a substantial global clinical team of approximately 3,800 people on six continents, allowing us to run clinical trials largely 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.

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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 .

We have built a highly productive and cost-effective oncology research team with 1,200+ 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 design each research program with a differentiated biological hypothesis, 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 small molecules, 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.

We have more than 20 CDAC and degrader-antibody conjugate programs progressing through our discovery, investigational new drug (“IND”) and clinical development stages.

Our research and innovation capabilities are optimized 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

Expanding our Foundational Hematology Franchise

Our hematology franchise is led by BRUKINSA, which is supported by a broad clinical program with over 7,900 patients enrolled in more than 30 countries and regions across more than 45 trials.

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

We continue to broaden our leadership in hematology, utilizing BRUKINSA as our foundational 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

BRUKINSA has allowed us to build a strong franchise in hematology-oncology and we plan to expand 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 are the only company offering potentially best-in-class, foundational medicines across the three key mechanisms of action in CLL, with BRUKINSA, sonrotoclax and our BTK-CDAC.

These assets show promise to offer best-in-disease combinations, and we have comprehensive registrational programs to address patient need in both the treatment naïve and relapsed settings, and with continuous use or fixed duration regimens.

Expanding Access to our PD-1 Inhibitor for Patients Worldwide and Building Global Commercial Capabilities to Support our 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.

We intend to expand TEVIMBRA’s global footprint through ongoing submissions and approvals, including submissions based on the HERIZON-GEA-01 trial.

We are also developing a hyaluronidase-free, 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.

We have established commercial capabilities in key large commercial markets of the U.S., EU and China, and continue our rapid expansion of capabilities into the 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 business model is sustainable and results in a strong global financial profile.

We believe we are financially well-positioned with cash and cash equivalents of $4.5 billion and debt of $1.0 billion as of December 31, 2025.

Our product revenue has grown 39.8% since 2024 from our current portfolio and cornerstone assets, which we expect to grow significantly in 2026 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 achieved GAAP net income and non-GAAP net income for the first time in fiscal year 2025.

We generated net cash provided by operating activities of $1.1 billion and positive free cash flow in 2025.

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.

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The following table summarizes the status of our commercial products as of February 26, 2026:

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

PRODUCT MECHANISM OF ACTION REGULATORY STATUS BEONE COMMERCIAL RIGHTS PARTNER

BRUKINSA ® (zanubrutinib)

BTK inhibitor Approved in 77 markets, incl.

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

TEVIMBRA ® (tislelizumab)

Anti-PD-1 antibody Approved in 51 markets, incl.

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

PARTRUVIX ® (pamiparib)

PARP inhibitor Approved in China Global N/A

Sonrotoclax BCL2 inhibitor Approved in China Global N/A

IMDELLTRA ® (tarlatamab) 1

Anti-DLL3 x anti-CD3 bispecific T-cell engager (BiTE) Approved in U.S.

Mainland China Amgen

XGEVA ® (denosumab)

Anti-RANK ligand antibody Approved in China Mainland China Amgen

BLINCYTO ® (blinatumomab)

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

KYPROLIS ® (carfilzomib)

Proteasome inhibitor Approved in China Mainland China Amgen

ZIIHERA ® (zanidatamab)

Anti-HER-2 bispecific antibody Approved in U.S., EU, China and Canada Asia (excluding Japan & India), Australia, New Zealand Jazz

SYLVANT ® (siltuximab)

IL-6 antagonist Approved in China Greater China Recordati

QARZIBA ® (dinutuximab)

Anti-GD2 antibody Approved in China Mainland China Recordati

POBEVCY ® (Avastin biosimilar)

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ALK inhibitor Approved in China China Broad Markets 2

A significant portion of our rights to receive certain tiered mid-single digit royalty payments based on annual net revenue from sales outside of China of IMDELLTRA were sold to Royalty Pharma in the third quarter of 2025.

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

Abbreviations:

DLL3 = delta-like ligand 3;

CD = cluster of differentiation;

ALK = anaplastic lymphoma kinase;

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

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

In 2025, global revenues for BTK inhibitors were approximately $12 billion according to company reported financials.

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

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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.

A tablet formulation was FDA approved in June 2025, providing patients with more convenience and flexibility.

BRUKINSA has approvals in five indications, including CLL/SLL, WM, R/R MCL, R/R MZL and R/R FL, and is approved in 77 markets and reimbursed in 58 markets.

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

BRUKINSA is the only BTK inhibitor 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 June 2025, BRUKINSA received approval of its tablet formulation.

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.

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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”).

In August 2025, BRUKINSA received approval from the EC of a film-coated tablet formulation for all approved indications.

In China, BRUKINSA has received approvals from the China National Medical Products Administration (“NMPA”) for the treatment of adult patients with CLL/SLL and WM, and conditional approvals for adult patients with R/R MCL and 3L FL.

Currently, all approved indications for BRUKINSA are included in the 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.

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Market Opportunity

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

Globally, the top four PD-1/PD-L1 antibody medicines had revenues of over $50 billion in 2025 based on public reports.

The 2025 China PD-1/L1 market (net revenue) was approximately $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.

Global revenues are projected to 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 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;

We have received regulatory approvals for TEVIMBRA marketing applications in multiple geographies, including the EU/European Medicines Agency (“EMA”) (comprising 27 countries plus Iceland and Norway) and 23 countries across North America, Europe, Asia Pacific and other markets.

TEVIMBRA was included in the NRDL in 2021 for second-line locally advanced or metastatic UC with high PD-L1 expression, in 2022 for first-line locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (“NSCLC”), first-line locally advanced unresectable or metastatic squamous NSCLC and second-line metastatic hepatocellular carcinoma (“HCC”), in 2023 for second-line locally advanced or metastatic NSCLC with driver gene negative/unknown, second-line metastatic MSI-H solid tumors, second-line locally advanced or metastatic esophageal squamous cell carcinoma (“ESCC”), and first-line recurrent or metastatic nasopharyngeal cancer (“NPC”), in 2024 for first-line locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma (“G/GEJA”) with high PD-L1 expression and first-line unresectable locally advanced, recurrent or metastatic ESCC, and in 2025 for first-line metastatic G/GEJA irrespective of PD-L1 expression status, first-line extensive stage small cell lung cancer (“ES-SCLC”) and first-line unresectable or metastatic HCC, and in 2026 for peri-operative treatment for resectable stage II and IIIA NSCLC.

Market Approval

China 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 NSCLC

in combination with etoposide and platinum chemotherapy as the first-line treatment for patients with extensive-stage small cell lung cancer

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 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 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

• for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma (“ESCC”) who have disease progression following or are intolerant to first-line standard chemotherapy;

for the treatment of patients with locally advanced or metastatic ESCC who have disease progression following or are intolerant to first-line standard chemotherapy

for first-line treatment of patients with locally advanced or metastatic ESCC in combination with chemotherapy

• for first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer (“NPC”);

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

• 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;

for first-line treatment of patients with recurrent or metastatic NPC

for first-line treatment of patients with unresectable or metastatic HCC

for the treatment of patients with advanced HCC who have received Sorafenib, Lenvatinib or systemic chemotherapy containing Oxaliplatin

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 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;

Market Approval

Europe 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

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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

in combination with etoposide and platinum chemotherapy, is indicated for the first-line treatment of adult patients with extensive-stage SCLC

in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of adult patients with recurrent, not amenable to curative surgery or radiotherapy, or metastatic NPC

in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of adult patients with resectable NSCLC at high risk of recurrence

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.

alternative dosing regimen of 400mg administered once every 6 weeks (Q6W) for all approved indications

Japan in combination with fluorouracil and cisplatin, is indicated for the first-line treatment of patients with unresectable locally advanced, recurrent or metastatic esophageal carcinoma (“EC”)

is indicated for patients with unresectable locally advanced, recurrent or metastatic EC that have progressed after cancer chemotherapy

in combination with platinum-containing chemotherapy for the first-line treatment of adults with unresectable or metastatic ESCC whose tumors express PD-L1 (≥1)

in adults with unresectable or metastatic ESCC after prior systemic chemotherapy that did not include a PD-L1 inhibitor

in combination with platinum and fluoropyrimidine based chemotherapy, for the first-line treatment of adults with unresectable or metastatic HER2 negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (≥ 1)

alternative dosing regimen of TEVIMBRA (tislelizumab) of 150mg administered once every 2 weeks (Q2W) of 300mg administered once every 4 weeks (Q4W) of 400mg administered once every 6 weeks (Q6W) in 1L /2L ESCC and GC

In-Licensed Products from Amgen

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KYPROLIS was included on the NRDL beginning in March 2023 for its approved indication in China.

In-Licensed Products from BMS

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

In-Licensed Products from Bristol-Myers Squibb Company (“BMS”)

As part of our settlement agreement with BMS, our commercialization of the following cancer medicines licensed from BMS terminated in 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.

and 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:

We commercialize the following medicines in China under an exclusive license from EUSA Pharma, a Recordati company:

SYLVANT (siltuximab), an interleukin-6 (“IL-6”) antagonist, was approved as a treatment for patients with idiopathic multicentric Castleman disease (“iMCD”) who are human immunodeficiency virus (“HIV”) negative and human herpesvirus-8 (“HHV-8”) negative.

SYLVANT was approved in China in December 2021 for the treatment of adult patients with multicentric Castleman disease (“MCD”) who are HIV negative and HHV-8 negative, also known as iMCD.

SYLVANT was approved in China in December 2021 for the treatment of adult patients with MCD who are HIV negative and HHV-8 negative, also known as iMCD.

Beginning in January 2024, Sylvant was included in the NRDL.

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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 and included in the NRDL in 2024.

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 (“BC”) in premenopausal and perimenopausal women that can be treated with hormones and included in the NRDL in 2024.

Reimbursement and Market Access

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We offer patient assistance programs in the U.S.

under our myBeiGene program.

under our myBeOne Support 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.

Oncology Nurse Advocates at myBeOne Support provide education and information about BRUKINSA and TEVIMBRA and their approved indications, and connect patients to advocacy organizations such as cancer 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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The NRDL is composed of three lists.

The ‘A’ and ‘B’ list are commonly referred to as the ‘regular’ lists.

The ‘A’ and ‘B’ lists are commonly referred to as the ‘regular’ lists.

The A list generally includes older, off-patent medicines, while the B list generally includes newer medicines, some with remaining patent protection, which are reimbursed at a lower rate compared to the A list.

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The NRDL price for a medicine is its prevailing price in China, but the actual reimbursement rate that is used can be modified at the provincial level.

Innovatively, in the 2022 NRDL, a price bidding process for non-exclusive drugs was undertaken on the C list to set the national reimbursement price benchmark.

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.

Several of our medicines are listed on the NRDL.

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 the 2022 NRDL, a price bidding process for non-exclusive drugs was undertaken on the C list to set the national reimbursement price benchmark.

Several of our medicines are listed in the NRDL.

The latest NRDL list was announced in December 2025.

The following medicines and indications have been included in the NRDL, effective January 1, 2026:

• TEVIMBRA in its eligible approved indications:

– In combination with platinum-based chemotherapy for neoadjuvant treatment, followed by continuation of this product as monotherapy for adjuvant treatment after surgery, for patients with resectable stage II or IIIA NSCLC (approved in October 2024 and included in the NRDL in 2025);

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

– In combination with etoposide and platinum chemotherapy as the first-line treatment for patients with ES-SCLC (approved in June 2024 and included in the NRDL in 2024);

– 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);

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 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:

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– 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);

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);

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– For the treatment of patients with locally advanced or metastatic 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 (conditionally approved in April 2020 and included in the NRDL in 2020).

– 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 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);

• BRUKINSA successfully renewed its approved indications:

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

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

2 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.

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

– 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).

• 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);

• BAITUOWEI successfully renewed its approved indications:

– For the treatment of patients with BC in premenopausal and perimenopausal women that can be treated with hormone therapy (approved in September 2023 and included in the NRDL in 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).

• KYPROLIS successfully renewed its approved indication in October 2024:

– 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).

• PARTRUVIX successfully renewed its eligible approved indications:

– For the 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 (approved in April 2021 and included in the NRDL in 2021).

• SYLVANT successfully renewed its approved indications:

– For the treatment of adult patients with multicentric Castleman disease (“MCD”) who are human immunodeficiency virus (“HIV”) negative and human herpesvirus-8 (“HHV-8”) negative (approved in December 2021 and included in the NRDL at the end of 2023).

In 2025, NHSA promulgated the first edition of the Commercial Health Insurance Innovative Drug List (“CHIIDL”).

It primarily includes innovative drugs with high innovation, significant clinical value, and substantial patient benefits that have not yet been included in the NRDL or for which NRDL coverage remains limited.

The CHIIDL is recommended for reference by multi-tiered medical security systems, including commercial health insurance and medical mutual aid.

The discount for drugs listed in the CHIIDL are determined through negotiations, with strict price confidentiality mechanisms.

The first edition of the CHIIDL was announced in December 2025.

The following medicines and indications have been listed:

• ZIIHERA in its approved indications:

– For the treatment of patients with unresectable locally advanced or metastatic biliary tract cancer who have previously received systemic therapy and are HER2-high (IHC 3+) (approved in May 2025 and included in the CHIIDL in 2025).

• QARZIBA in its approved indications:

– For the treatment of patients ≥12 months of age with high-risk neuroblastoma who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplant;

also for the treatment of relapsed or refractory neuroblastoma with or without residual disease.

Prior to treatment of relapsed neuroblastoma, appropriate measures should be taken to stabilize active progressive disease(approved in August 2021 and included in the CHIIDL in 2025).

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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The system is still evolving and, as such, the exact terms of how many bidders win and what amount of volume is won and at what price are also evolving.

1 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.

It is common in China for pharmaceutical companies to employ patient assistance programs to help patients afford their innovative medicines.

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

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

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Amgen Tarlatamab ^

SCLC Phase 3 China

Xaluritamig Prostate cancer Phase 1 China

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

SCLC Phase 3 Mainland China

Xaluritamig Prostate cancer Phase 1 Mainland China

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

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

SpringWorks BGB-3245 1

Solid tumors Phase 1 Ex-Asia plus Japan

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

Ensem CDK2i BC and other solid tumors Phase 1 Global

CSPC MAT2Ai Solid tumors Phase 1 Global

Half-life extended BiTE ® ;

1 By MapKure, a JV with SpringWorks

* Excluding Japan and India

Abbreviations:

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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, bone marrow and lymph node compartments in patients.

Zanubrutinib has demonstrated sustained 24-hour BTK occupancy in 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.

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BRUKINSA is approved in more than 75 markets, and more than 265,000 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;

Long‑term results from the SEQUOIA study demonstrate sustained clinical benefit with BRUKINSA® (zanubrutinib), reinforcing its differentiated profile in frontline CLL, both as monotherapy and in combination with venetoclax.

These data were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

Additional SEQUOIA results presented at the 2025 American Society of Hematology (ASH) Annual Meeting further confirm the durability of efficacy, showing sustained disease control in treatment‑naïve CLL/SLL patients and continued favorable survival outcomes in the non‑randomized del(17p) cohort at 6 years of follow‑up.

Final analysis of the randomized Phase 2 ROSEWOOD study of zanubrutinib plus obinutuzumab (“ZO”) vs obinutuzumab monotherapy in patients with R/R FL confirmed the favorable risk-benefit profile of ZO.

The objective response rate (“ORR”) and complete response (“CR”) rate with ZO improved over time, responses remained durable, and the PFS benefit over O was sustained.

ZO had a manageable safety profile with no new safety signals observed;

detailed data were presented at the annual ASH 2025 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.

Results from the ALPINE trial in patients with CLL/SLL showed reduced risk of symptom deterioration associated with earlier disease progression in comparison with ibrutinib;

detailed data were presented at the annual ASH 2025 conference.

Based on the clinical data to date, we believe that BRUKINSA has a best-in-class profile and 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).

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

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

A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma (MAHOGANY).

A Global Phase 3 study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL, including participants without del(17p) [Cohort 1] and participants with del(17p) [Cohort 2 and Cohort 3].

Participants in Cohort 1 are randomized 1:1 to zanubrutinib (Arm A) or bendamustine plus rituximab (Arm B).

Randomization will be stratified by age, Binet stage, immunoglobulin variable region heavy chain (IGHV) mutational status, and geographic region.

Participants in Cohort 2 will receive treatment with zanubrutinib.

Participants in Cohort 3 will receive treatment with zanubrutinib and venetoclax (NCT03336333).

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.

We continue to pursue regulatory approvals for BRUKINSA globally.

Sonrotoclax (BGB-11417), a Small Molecule BCL2 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.

We believe that efficacy signals and safety data from more than 2,500 patients enrolled through February 2026 in different indications and in different combinations continue to support the pre-clinical best-in-class promise.

This year marked a series of significant milestones for the sonrotoclax program.

Sonrotoclax was granted approval in China for adult patients with R/R MCL and CLL/SLL patients who have received at least one systemic therapy, including a BTK inhibitor.

The approval is supported by data demonstrating deep and durable responses and manageable tolerability based on parallel submissions of data from two studies.

In the Phase 1/2 single-arm study of patients with R/R MCL treated with 320 mg of sonrotoclax (n=103), overall response rate (ORR) as assessed by independent review committee (IRC) was 52.4% (95% CI, 42.4-62.4).

In the Phase 2 open-label study of patients with R/R CLL/SLL treated with sonrotoclax (n=100), ORR as assessed by IRC was 77%.

We announced positive topline results for the Phase 2 sonrotoclax study in R/R MCL (NCT05471843) in August 2025.

The study met its primary endpoint of ORR, and the study also showed promising results across several secondary efficacy endpoints, including CR rate, duration of response (“DOR”) and PFS.

The safety profile was generally well-tolerated, and the toxicities were manageable.

Based on these results, sonrotoclax was granted Breakthrough Therapy Designation for the treatment of adult patients with R/R MCL by the FDA in October 2025.

Our new drug application of sonrotoclax for the treatment of adult patients with R/R MCL, following treatment with a BTK inhibitor, was granted Priority Review by the FDA in November 2025.

In R/R CLL, our China-only pivotal Phase 2 trial (NCT05479994) had a positive readout based on 12-month follow-up.

The 6-month follow up data formed the basis of our initial submission in China in April 2025, and a rolling submission of our 12-month follow-up data into the China NDA has been completed.

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.

A Phase 2 study of sonrotoclax as monotherapy and in combinations with zanubrutinib in patients with R/R WM (NCT05952037) and a Phase 3 study of sonrotoclax plus zanubrutinib compared with venetoclax plus obinutuzumab in patients with TN CLL/SLL (NCT06073821) have completed enrollment.

Our Phase 2 study of sonrotoclax plus zanubrutinib compared with zanubrutinib monotherapy, which is a regulatory requirement of our TN CLL filing package, also completed enrollment.

Initial results from an ongoing Phase 1/1b study (NCT04277637) were presented at ASH 2025.

Sonrotoclax plus obinutuzumab was generally well-tolerated in patients with TN CLL/SLL, with no sonrotoclax discontinuations or deaths due to TEAEs.

No laboratory or clinical TLS events occurred during sonrotoclax ramp-up.

Encouraging antitumor activity was observed with sonrotoclax 320 mg.

High rates of blood uMRD4 occurred early and deepened over time.

All patients with an available C15 MRD assessment by NGS or FC achieved uMRD4 and remain in remission.

Initial results from an ongoing Phase 1b/2 study with sonrotoclax (NCT04973605) as monotherapy and in various combinations with carfilzomib and dexamethasone in patients with t(11;14)-positive R/R MM were also presented at ASH 2025.

The sonrotoclax combination therapy demonstrated a tolerable safety profile and encouraging antimyeloma activity, with an 84% ORR and a 32% CR/sCR rate in heavily pretreated patients with t(11;14)-positive R/R MM.

With these encouraging results, our sonrotoclax program is steadily progressing with its first global approval, its first FDA and EMA new drug applications under review, and ongoing pivotal stage global development.

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.

BGB‑16673 is an orally available, brain-penetrating BTK targeting 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 1,000 patients treated to date across the global CaDAnCe clinical development program.

The FDA granted Fast Track Designation to BGB-16673 in 2024 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 a BTK inhibitor and a BCL2 inhibitor, and adult patients with R/R MCL.

In July 2025, we achieved PRIME designation from the EMA for BGB-16673 for the treatment of patients with WM previously treated with a BTK.

Updated efficacy and safety results from the ongoing Phase 1 CaDAnCe-101 study in patients with R/R CLL/SLL were presented at ASH 2025.

Data demonstrate that BGB-16673 has a tolerable safety profile and shows robust and deepening responses in heavily pretreated patients.

A Phase 2 expansion cohort of this study is enrolling in R/R CLL after BCL2 inhibitor and BTK inhibitor directed therapy (NCT05006716), and enrollment is ongoing in three Phase 3 studies (NCT06846671, NCT06970743, NCT06973187) designed to support filings in later lines of CLL, including a potential accelerated approval filing in R/R CLL in 2026 if data support such submission.

In October 2025, we achieved first subject enrolled in CaDAnCe-304, our head-to-head study versus pirtobrutinib in R/R CLL.

We are also enrolling in a platform study (NCT06634589) to generate combination data of strategic importance across multiple B-cell malignancies.

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

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.

Tislelizumab is a humanized monoclonal antibody against the immune checkpoint receptor PD-1 that has been evaluated in pivotal clinical trials globally.

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 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).

We have completed more than 15 registration-enabling clinical trials in lung, liver, urothelial carcinoma, and nasopharyngeal cancer globally, including 11 Phase 3 randomized trials and four Phase 2 trials supporting regulatory submissions globally.

We have four active studies in HER2+ gastroesophageal adenocarcinoma (“GEA”), urothelial carcinoma, gastric cancer, and solid tumors:

• The Phase 3 HERIZON-GEA-01 trial evaluates ZIIHERA ® (zanidatamab), a HER2-targeted bispecific antibody, in combination with chemotherapy, with and without TEVIMBRA, as a first-line treatment for HER2-positive locally advanced or metastatic GEA.

• A Phase 3 confirmatory trial in China to investigate tislelizumab plus either cisplatin or carboplatin plus gemcitabine in patients with locally advanced or metastatic urothelial carcinoma (NCT03967977).

• A global Phase 3 trial to investigate tislelizumab administered as subcutaneous injection versus intravenous infusion plus chemotherapy in patients with unresectable or metastatic gastric or gastroesophageal junction (“GEJ”) adenocarcinoma (NCT07043400).

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

Notably, the data from the first interim analysis of the HERIZON-GEA-01 trial were announced in January 2026 during the ASCO Gastrointestinal Cancers Symposium (“ASCO GI”).

The addition of TEVIMBRA to ZIIHERA and chemotherapy demonstrated statistically significant and clinically meaningful improvements in both PFS and overall survival (“OS”) compared to the control arm, regardless of PD-L1 expression level.

Results showed a 37% reduction in the risk of disease progression and a greater than 4-month improvement in mPFS as well as a 28% reduction in the risk of death and a greater than 7-month improvement in mOS.

There is a high GEA burden in Asia, where we hold ZIIHERA rights, excluding Japan and India, along with TEVIMBRA.

We intend to submit supplemental BLAs to the FDA for TEVIMBRA and to the Center for Drug Evaluation (“CDE”) of the NMPA for TEVIMBRA and ZIIHERA, based on these data.

We also intend to work with regulatory authorities in our licensed territories to expedite regulatory submissions in these markets.

As of December 2025, we had enrolled over 15,800 subjects in clinical trials of tislelizumab monotherapy or in combination in more than 33 countries, including 5,000+ subjects outside of China.

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

These studies include nine 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 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.

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-EGFR x MET x MET trispecific antibody

BG-T187 is an investigational anti-EGFR x MET x MET 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.

BG-C0902, an EGFR x MET x MET trispecific ADC

BG-C0902 is an investigational EGFR x MET x MET trispecific ADC being evaluated in a Phase 1 clinical trial (NCT07181681) as monotherapy or in combination with other therapeutic agents in patients with advanced solid tumors.

BG-60366, an EGFR-targeted CDAC

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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.

BG-89894 (SYH2039) is an investigational MAT2A inhibitor being evaluated in multiple Phase 1 clinical trials as mono and combo therapy 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

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 patients with advanced 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.

BGB-C354, an anti-B7-H3 ADC (development discontinued)

BGB-C354 is an investigational ADC targeting B7-H3 that was being evaluated in a Phase 1 clinical trial (NCT06422520) as monotherapy or in combination with tislelizumab in patients with advanced solid tumors.

The trial is in closeout.

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.

ZIIHERA ® (zanidatamab), a novel investigational bispecific antibody targeting HER2, is approved in the U.S., China, Canada and other markets for adults with previously treated, unresectable or metastatic HER2 positive (IHC 3+) biliary tract cancer (“BTC”).

Zanidatamab is currently in late-stage clinical development with Zymeworks Inc./Jazz Pharmaceuticals plc (“Jazz”).

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

In November 2025, Jazz announced positive top-line results from the HERIZON-GEA-01 trial, and full data were disclosed at ASCO GI 2026.

A BLA for the HER2-amplified BTC indication in which zanidatamab is being used as monotherapy was approved by China NMPA in May 2025.

In June 2025, Jazz announced that the Marketing Authorization Application for zanidatamab in 2L BTC was granted conditional marketing authorization by the EMA.

BeOne intends to submit supplemental BLAs to the FDA for TEVIMBRA and to the CDE of the NMPA for TEVIMBRA and ZIIHERA, based on results from the HERIZON-GEA-01 trial.

We also intend to work with regulatory authorities in our licensed territories to expedite regulatory submissions in these markets.

We continue to participate with Jazz in a confirmatory study (NCT06282575) as first line treatment for subjects with HER2 + BTC.

In January 2026, the New Drug Submission (“NDS”) for ZIIHERA was approved by Health Canada for the treatment of adults with previously treated, unresectable locally advanced or metastatic HER2-positive (IHC 3+) BTC, as monotherapy.

The approval was granted under Health Canada’s Notice of Compliance with Conditions pathway.

BGB-B2033, an anti-GPC3 x 4-1BB bispecific antibody

BGB-B2033 is an investigational anti-GPC3 x 4-1BB bispecific antibody being evaluated in a Phase 1 clinical trial (NCT06427941) as monotherapy or in combination with tislelizumab and bevacizumab in patients with selected advanced or metastatic solid tumors.

In December 2025, the FDA granted Fast Track Designation to BGB-B2033 for the treatment of adult patients with HCC with disease progression on or after prior systemic treatment.

BG-C477, an anti-CEA ADC

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

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.

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

BGB-26808, an HPK-1 Inhibitor

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.

BGB-B3227, an anti-MUC1 x CD16A bispecific antibody (development discontinued)

BGB-B3227 is an investigational anti-MUC1 x CD16A bispecific antibody that was being evaluated in a Phase 1 clinical trial (NCT06540066) as monotherapy or in combination with tislelizumab in patients with advanced or metastatic solid tumors.

The trial is in closeout.

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 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-B7-H4 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 an investigational ADC targeting B7-H4 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.

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 in patients with HR+ and HER2- BC and other advanced solid tumors.

BG-68501 is licensed from Ensem Therapeutics, Inc.

BG-75098, a CDK2 CDAC

BG-75098 is an investigational CDK2 CDAC being evaluated in a Phase 1 clinical trial (NCT07226349) alone and in combination with BGB-43395 and fulvestrant in participants with advanced solid tumors.

BGB-75202, a KAT6A/B Inhibitor

BG-75202 is an investigational lysine acetyltransferase (“KAT6A/B”) inhibitor being evaluated in a Phase 1 clinical trial (NCT07222267) alone and in combination with other therapies in participants with breast cancer and other advanced solid tumors.

BGB-21447, a BCL2 Inhibitor

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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-B445, an anti-Claudin 6 x CD3 bispecific antibody

BGB-B445 is an investigational anti-claudin 6 x CD3 bispecific antibody being evaluated in a Phase 1 clinical trial (NCT06803680) as a monotherapy in advanced or metastatic solid tumors.

Immunology & Inflammation

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.

BGB-45035 is an investigational interleukin-1 receptor-associated kinase 4 (“IRAK4”) targeting CDAC being evaluated in a Phase 1 clinical trial (NCT06342713) as monotherapy in healthy participants and patients with atopic dermatitis or prurigo nodularis and in a Phase 2 clinical trial (NCT07100938) in adults with moderate to severe active rheumatoid arthritis.

BGB-16673, a BTK targeted CDAC

BGB-16673 is being evaluated in a Phase 1 clinical trial (NCT07005713) in adults with chronic spontaneous urticaria.

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 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.

We have core technology platforms for the development of small molecule and antibody medicines and the manufacturing of our own and potentially other medicines.

We have deep expertise in designing small molecule inhibitors and biologics, and are emerging leaders in protein degradation, bi- and tri-specific antibodies, and ADCs.

In the last decade, our preclinical research and development platform has generated more than 35 clinical stage assets, including four internally-developed molecules that have been commercially approved.

In 2024 and 2025, we advanced 18 NMEs into the clinic.

Our discovery engine 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.

Currently, we have over 70 preclinical programs and we believe the majority have best-in-class or first-in-class potential.

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/clinical candidates to target multiple points in the cancer immunity cycle.

We believe that we have the opportunity to combine assets within our pipeline.

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 CMOs.

We manufacture our medicines and drug candidates internally and in some cases with the help of contract manufacturing organizations (“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 (“cGMP”) regulations 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”) conditions.

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

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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.

manufacturing 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 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.

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.

This site is now fully online with the successful technology transfer and qualification of our TEVIMBRA process, marking our first U.S.-based expected commercial manufacturing.

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 approximately 600 million tablets and capsules.

The facility meets or exceeds design criteria of the U.S., EU, and China regulatory requirements, and has been in operation for clinical product supply since the beginning of 2024, with commercial supply in operation since May 2025.

The biologics manufacturing business at the former site in Suzhou concluded in January 2025, with some quality control testing expected to continue until the second quarter of 2026.

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

Phases 1 and 2 (completed in September 2019 and December 2020, respectively) provide 24,000 liters of single-use bioreactor capacity and are approved for end-to-end commercial manufacturing of TEVIMBRA for the China market.

In 2024, we qualified Phase 3 capacity consisting of eight 5,000-liter bioreactors, increasing total capacity to 64,000 liters.

Additionally, in April 2024, we commissioned a new campus that includes an ADC manufacturing facility and 1,000 liters of biologics clinical production capacity.

The campus also includes reserved land for future expansion to support pipeline development.

Following this expansion, total biologics manufacturing capacity at the Guangzhou facility will be approximately 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 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.

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

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.

An ex-China active pharmaceutical ingredients (“API”) source was approved by both FDA and EMA in 2025.

For our commercial and clinical stage products in-licensed from Amgen 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.

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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 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.

Raw materials and starting materials used at our facilities include APIs custom-made by our third-party CMOs 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.

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Collaboration Agreement

On October 31, 2019, our wholly-owned subsidiary, BeiGene Switzerland GmbH (“BeiGene Switzerland”), entered into a Collaboration Agreement with Amgen, which became effective on January 2, 2020 (as amended, the “Amgen Collaboration Agreement”).

Pursuant to the terms of the Amgen Collaboration Agreement, we are responsible for commercializing Amgen’s oncology products XGEVA, BLINCYTO and KYPROLIS in China (excluding Hong Kong, Macao and Taiwan) for a period of five or seven years following each product’s regulatory approval in China, as specified in the Amgen Collaboration Agreement, with the commercialization period for XGEVA commencing following the transition of operational responsibilities for the product.

In addition, as specified in the agreement, we have the option to retain one of the three products to commercialize for as long as the product is sold in China.

The parties have agreed to equally share profits and losses for the products in China during each product’s commercialization period.

After expiration of the commercialization period for each product, the products not retained will be transitioned back to Amgen and we will be eligible to receive tiered mid-single to low-double digit royalties on net sales in China of each product for an additional five years.

On October 31, 2019, our wholly-owned subsidiary, BeOne Medicines I GmbH, entered into a Collaboration Agreement with Amgen, which became effective on January 2, 2020 (as amended, the “Amgen Collaboration Agreement”).

Pursuant to the terms of the Amgen Collaboration Agreement, we are responsible for commercializing Amgen’s oncology products XGEVA ® , BLINCYTO ® and KYPROLIS ® in China (excluding Hong Kong, Macao and Taiwan) (“Collaboration Territory”), with the commercialization period for XGEVA ® commencing following the transition of operational responsibilities for the product.

The parties have agreed to equally share profits and losses for the products in the Collaboration Territory during each product’s commercialization period.

We entered into an amendment to the Amgen Collaboration Agreement in November 2025 to extend our commercialization rights to these products in the Collaboration Territory for so long as each product is sold in the Collaboration Territory following each product’s regulatory approval in the Collaboration Territory.

Additionally, pursuant to the terms of the Amgen Collaboration Agreement, we and Amgen have agreed to collaborate on the global clinical development and commercialization of a portfolio of Amgen clinical- and late-preclinical-stage oncology pipeline products.

Starting from the commencement of the Amgen Collaboration Agreement, we and Amgen will co-fund global development costs, with BeiGene contributing up to $1.25 billion worth of development services and cash over the term of the collaboration.

We will be eligible to receive tiered mid-single digit royalties on net sales of each product globally outside of China on a product-by-product and country-by-country basis, until the latest of the expiration of the last valid patent claim, the expiration of regulatory exclusivity, or the earlier of eight years after the first commercial sale of such product in the country of sale and 20 years from the date of first commercial sale of such product anywhere in the world.

For each pipeline product that is approved in China, we will have the right to commercialize the product for seven years, with the parties sharing profits and losses for the product in China equally.

In addition, we will have the right to retain approximately one of every three approved products, up to a total of six, other than AMG 510, to commercialize for as long as each such product is sold in China.

After the expiration of the seven-year commercialization period, each product will be transitioned back to Amgen and we will be eligible to received tiered mid-single to low-double digit royalties on net sales in China for an additional five years.

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

Starting from the commencement of the Amgen Collaboration Agreement, we and Amgen will co-fund global development costs, with BeOne contributing up to $1.25 billion worth of development services and cash over the term of the collaboration.

We will be eligible to receive tiered mid-single digit royalties on net sales of each product globally outside of the Collaboration Territory on a product-by-product and country-by-country basis, until the latest of the expiration of the last valid patent claim, the expiration of regulatory exclusivity, or the earlier of eight years after the first commercial sale of such product in the country of sale and 20 years from the date of first commercial sale of such product anywhere in the world.

For each pipeline product that is approved in the Collaboration Territory, we will have the right to commercialize the product for seven years, with the parties sharing profits and losses for the product in the Collaboration Territory equally.

After the expiration of the seven-year commercialization period, each product will be transitioned back to Amgen and we will be eligible to receive tiered mid-single to low-double digit royalties on net sales in the Collaboration Territory for an additional five years.

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

For more information regarding our rights to royalties from sales of IMDELLTRA ® , please see “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Recent Business Developments—Royalty Purchase Agreement.”

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 us.

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and (ii) cooperate in good faith to prepare a transition plan with the termination of AMG 510 from the Amgen Collaboration Agreement.

BeiGene, Ltd.

has guaranteed certain obligations of BeiGene Switzerland under the Amgen Collaboration Agreement pursuant to the terms of a separate Guarantee Agreement.

BeOne Medicines Ltd.

has guaranteed certain obligations of BeOne Medicines I GmbH under the Amgen Collaboration Agreement pursuant to the terms of a separate Guarantee Agreement.

The Amgen Collaboration Agreement contains customary representations, warranties and covenants by the parties.

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The agreement may be terminated by mutual written consent of the parties, or by either party upon the other party’s uncured material breach, insolvency, failure to comply with specified compliance provisions, or subject to a specified negotiation mechanism, certain adverse economic impacts or the failure to meet commercial objectives.

In addition, Amgen may terminate the agreement with respect to a pipeline product in the event it suspends development of such pipeline product on specified terms, subject to the parties determining whether to continue development of the pipeline product in China.

Share Purchase Agreement

In connection with the Amgen Collaboration Agreement, pursuant to a share purchase agreement dated October 31, 2019, as amended, by and between BeiGene, Ltd.

In connection with the Amgen Collaboration Agreement, pursuant to a share purchase agreement dated October 31, 2019, as amended, by and between BeOne Medicines Ltd.

and Amgen (as amended, the “Share Purchase Agreement”), we issued to Amgen 206,635,013 ordinary shares in the form of 15,895,001 ADSs of the Company on January 2, 2020, representing approximately 20.5% of our then outstanding shares, for an aggregate purchase price of $2.78 billion, or $13.45 per ordinary share, or $174.85 per ADS.

Pursuant to the Share Purchase Agreement, Amgen agreed to (i) a lock-up on sales of its shares until the earliest of (a) the fourth anniversary of the closing, (b) the expiration or termination of the Collaboration Agreement and (c) a change of control of BeiGene, Ltd., (ii) a standstill until the date on which it holds less than 5% of our then outstanding shares, and (iii) a voting agreement to vote its shares on certain matters presented for shareholder approval until the later of (a) the fifth anniversary of the closing and (b) the expiration of the standstill period, all under specified circumstances and as set forth in the agreement.

Pursuant to the Share Purchase Agreement, Amgen agreed to (i) a lock-up on sales of its shares until the earliest of (a) the fourth anniversary of the closing, (b) the expiration or termination of the Collaboration Agreement and (c) a change of control of BeOne Medicines Ltd., (ii) a standstill until the date on which it holds less than 5% of our then outstanding shares, and (iii) a voting agreement to vote its shares on certain matters presented for shareholder approval until the later of (a) the fifth anniversary of the closing and (b) the expiration of the standstill period, all under specified circumstances and as set forth in the agreement.

Following the later of (i) the expiration of the lock-up period and (ii) the expiration of the standstill period, Amgen has agreed not to sell shares representing more than 5% of our then outstanding shares in any rolling 12-month period.

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Additionally, we have agreed to use reasonable best efforts to provide Amgen with an opportunity to participate in subsequent new securities offerings upon the same terms and conditions as other purchasers in the offering in an amount needed to allow Amgen to hold up to 20.6% of our shares, subject to applicable law and HKEx rules and other specified conditions.

On March 17, 2020, BeiGene, Ltd.

On March 17, 2020, BeOne Medicines Ltd.

and Amgen entered into an Amendment No.

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The exercise period of the Direct Purchase Option commenced on December 1, 2020 and terminated on December 1, 2023.

On January 30, 2023, BeiGene, Ltd.

On January 30, 2023, BeOne Medicines Ltd.

and Amgen entered into an Amendment No.

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Hooper, who was Amgen’s director designee on the Company’s board of directors until Amgen relinquished its right to appoint a designated director.

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

Hooper was most recently re-elected by shareholders in 2025.

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 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.

and other countries and regions, such as Europe, Japan 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.

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Composition of matter 2034

Pharmaceutical composition 2034

Method of treatment 2034

Crystalline forms 2037

Method of treatment 2037

Combination use 2039

Method of treatment 2043

Formulation 2040

Europe Composition of matter 2034 2

Europe Combination use 2037 3

Europe Crystalline form 2037

Japan Composition of matter 2034 4

Japan Crystalline forms 2037 4

Japan Crystalline forms 2037

China Composition of matter 2034 5

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Composition of matter 2033 6

Composition of matter 2033

Polynucleotide 2033

Method of treatment 2039

Europe Composition of matter for antibodies 2033 5

Europe Composition of matter 2033 7

Japan Composition of matter 2033

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China Composition of matter 2031

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.

Composition of matter 2038

Japan Composition of matter 2038

China Composition of matter 2038

Sonrotoclax U.S.

Composition of matter 2039

Europe Composition of matter 2039

Japan Composition of matter 2039

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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.

SPCs have been filed in various European countries and have been granted at least in France, Germany, Italy, Spain and the UK, 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).

Three PTE applications have been filed in Japan.

An application for PTE has been filed in China.

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.

Multiple PTE applications have been filed in China.

Under our license and collaboration agreement with Zymeworks Inc.

(“Zymeworks”), we have the right to develop and commercialize ZIIHERA ® in certain Asian pacific countries.

The key patents for it in China as of February 13, 2026 are summarized below:

Product Territory General Subject Matter Expiration

China Composition of matter 2031

China Composition of matter 2032

China Composition of matter 2034

China Method of use 2039

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

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BLINCYTO ® (blinatumomab)

China Use for the treatment of pediatric acute lymphoblastic leukemia 2029

KYPROLIS ® (carfilzomib)

China Compound and Composition 2025

China Method of use 2029

China Combination use 2031

We have one in-licensed medicine in China from Shandong Luye Pharmaceutical Co., Ltd (“Luye”).

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China Formulation 2034

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 we retain the responsibility, but is not obligated, to defend and enforce the patents for the corresponding in-licensed product.

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

Under our license agreement with Amgen, Amgen retains the responsibility, but is 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 we retain the responsibility, but are 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.

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

Eli Lilly JAYPIRCA U.S., China & Japan

Innocare YINUOKAI China

Eli Lilly JAYPIRCA U.S., Europe, China & Japan

Innocare YINUOKAI China, Singapore

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

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

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

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

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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”).

Junshi LOQTORZI U.S., Europe, China & Middle Eastern

Henlius HANSIZHUANG U.S., Europe, India, Peru & China

Various Chinese companies 20+ products including PD-1/L1, IO BsAb China

Sonrotoclax AbbVie & Roche VENCLEXTA China

Ascentage Pharma Lisaftoclax China

In addition, we have several promising candidates in the pivotal development stage, including BGB-16673, a BTK-targeted CDAC.

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

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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.

Sonrotoclax Ascentage Pharma Lisaftoclax Phase 3 Global

Innocare Mesutoclax Pivotal Phase 2/3 China

BGB-16673 Nurix Therapeutics NX-5948 Pivotal Phase 2 Global

Furthermore, we are advancing several promising candidates through pivotal programs, including ADCs, multispecific antibodies, and targeted therapies for lung, breast, and gastrointestinal cancers.

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.

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• payment of user fees for FDA review of the NDA or BLA (unless a fee waiver applies);

• FDA audits of some clinical trial sites to ensure compliance with GCPs;

• FDA review and approval of the NDA or licensing of the BLA.

• FDA inspection of some clinical trial sites to ensure compliance with GCPs;

• FDA Sponsor/Monitor inspections;

• FDA review and approval of the NDA or licensing of the BLA and labeling;

• Alignment on post-marketing requirements/commitments (if applicable).

Preclinical Studies and Clinical Trials

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This group provides authorization as to whether or not a trial may move forward at designated check points based on access that only the group maintains to available data from the trial and may recommend halting the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds, such as no demonstration of efficacy.

Each new clinical protocol and any amendments to the protocol must be filed with the FDA as an IND amendment and submitted to the IRBs for approval.

Each new clinical protocol and amendments that significantly affect the safety of subjects, the scope of the investigation, or the scientific quality of the protocol must be filed with the FDA as an IND protocol amendment and submitted to the IRBs for approval.

A sponsor who wishes to conduct a clinical trial outside of the U.S.

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Post-approval trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval.

These trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication and are commonly intended to generate additional safety data regarding use of the product in a clinical setting.

These trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication and are commonly intended to generate additional data regarding use of the product in a clinical setting.

In certain instances, the FDA may mandate the performance of Phase 4 clinical trials as a condition of approval of an NDA or BLA.

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.

Progress reports detailing the results of the clinical trials must be submitted annually (or possibly twice 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 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

Expanded access, sometimes called “compassionate use,” is the use of investigational products outside of clinical trials to treat patients with serious or immediately life-threatening diseases or conditions when there are no comparable or satisfactory alternative treatment options.

There is no requirement for a company to provide expanded access to its investigational products.

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 our contact information for requesting access to our investigational drugs and expected timeline for us to acknowledge receiving such requests.

Review and Approval Processes

The results of product development, preclinical studies and clinical trials, along with descriptions of the CMC, analytical tests conducted on the product, proposed labeling and other relevant information, are submitted to the FDA as part of an NDA for a new small molecule drug or a BLA for a biologic, requesting approval to market the product.

The submission of an NDA or BLA is subject to the payment of a substantial user fee, although a waiver of such fee may be obtained under certain limited circumstances.

The sponsor of an approved NDA or BLA is also subject to an annual prescription drug product program fee.

The FDA may request additional information rather than accept an NDA or BLA for filing.

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Before approving an NDA or BLA, the FDA typically will inspect the facility or facilities where the product is or will be manufactured.

The FDA will not approve an application unless it determines that the manufacturing processes and facilities comply with cGMP requirements and adequate to assure consistent production of the product within required specifications.

Additionally, before approving an NDA or BLA, the FDA may inspect one or more clinical trial sites to assure compliance with GCP and other requirements and the integrity of the clinical data submitted to the FDA.

The approval process can be lengthy and difficult, and the FDA may refuse to approve an NDA or BLA if the applicable regulatory criteria are not satisfied or may require additional data and information.

The FDA will not approve an application unless it determines that the manufacturing processes and facilities comply with cGMP requirements and adequate to ensure consistent production of the product within required specifications.

Even if such data and information are submitted, the FDA may ultimately decide that the NDA or BLA does not satisfy the criteria for approval.

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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 IMM or other clinical benefit.

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.

Under FDORA, the FDA is empowered to take action, such as issuing fines, against companies that fail to conduct any post-approval confirmatory study with due diligence or to submit timely reports to the agency on their progress.

It is important to note that per the FDA requirements, unless otherwise informed by the FDA, all promotional materials to be used need to be submitted 120 days prior to approval.

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.

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Under the Pediatric Research Equity Act of 2003, all marketing applications for new active ingredients, indications, dosage forms, dosing regimens or routes of administration must contain an assessment of the safety and effectiveness of the product for the claimed indication in pediatric patients unless this requirement is waived, deferred or inapplicable.

For oncology products, PREA requirements are further modified by the Research to Accelerate Cures and Equity (“RACE”) for Children Act of 2017, enacted as part of the FDA Reauthorization Act (“FDARA”), which removed the exemption for orphan-designated oncology indications.

Under RACE, unless waived or deferred, pediatric assessments are required if the molecular target of the product is substantially relevant to the growth or progression of a pediatric cancer, regardless of whether the adult indication has orphan designation or does not occur in the pediatric population.

These requirements apply to applicable original NDAs and BLAs submitted on or after August 18, 2020.

Under the Best Pharmaceuticals for Children Act, a product may be eligible for pediatric exclusivity, which adds six months to existing exclusivity periods and patent terms.

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Further, manufacturers must continue to comply with cGMP requirements, which are extensive and require considerable time, resources and ongoing investment to ensure compliance.

In addition, changes to the manufacturing process generally require prior FDA approval before being implemented and other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further FDA review and approval.

In addition, certain types of changes to the manufacturing process generally require prior FDA approval before being implemented and other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further FDA review and approval.

Manufacturers and other entities involved in the manufacturing and distribution of approved products are required to register their establishments with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws.

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Information related to the product, patient population, phase of investigation, study sites and investigators, and other aspects of the clinical trial is then made public as part of the registration.

Sponsors are also obligated to disclose the results of their clinical trials after completion.

Disclosure of the results of these trials can be delayed until the new product or new indication being studied has been approved.

Although sponsors are obligated to disclose the results of their clinical trials after completion, disclosure of the results can be delayed in some cases for up to two years after the date of completion of the trial.

Failure to timely register a covered clinical study or to submit study results as provided for in the law can give rise to public notification of noncompliance, civil monetary penalties and also prevent the non-compliant party from receiving future grant funds from the federal government.

Competitors may use this publicly available information to gain knowledge regarding the progress of development programs.

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Department of Health and Human Services (“HHS”) rebate rule that would have limited the fees that pharmacy benefit managers can charge.

Further, under the IRA, orphan drugs are exempted from the Medicare drug price negotiation program, but only if they have one orphan designation and for which the only approved indication is for that disease or condition.

Under the IRA, an orphan drug is exempt from the Medicare drug price negotiation program only if it has a single orphan designation and its sole approved indication is for that disease or condition.

The One Big Beautiful Bill Act of 2025 (“OBBBA”) removes this limitation.

Beginning with the 2028 initial price applicability year, all orphan drugs—regardless of the number of orphan designations or approved indications—are exempt from the Medicare drug price negotiation program.

However, an orphan drug loses this exemption once it receives approval for any non-orphan indication, at which point it becomes eligible for selection for Medicare drug price negotiation.

The implementation of the IRA is currently subject to ongoing litigation challenging the constitutionality of the IRA’s Medicare drug price negotiation program.

The effects of the IRA on our business and the healthcare industry in general is not yet known.

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.

Although certain provisions of the IRA remain subject of ongoing litigation, the Centers for Medicare and Medicaid Services (“CMS”) has started implementing key components of the law, including inflation-based rebates and the Medicare drug price negotiation program, and these provisions are expected to have an impact on our business and the healthcare industry in general.

On November 6, 2025, CMS announced a new drug payment model designed to make Most Favored Nation (“MFN”)-level prices available to state Medicaid programs via manufacturer rebates.

Referred to as the “GENErating cost Reductions fOr U.S.

Medicaid Model” (“GENEROUS”), the initiative is designed to run from 2026 through 2030 and is voluntary for both manufacturers and state Medicaid programs.

Under the model, participating states will be able to access MFN-level prices for participating manufacturers’ drugs through CMS-negotiated supplemental rebates tied to an MFN net price benchmark.

On December 19, 2025, CMS proposed a mandatory Center for Medicare and Medicaid Innovation (“CMMI”) drug payment model to test whether alternative methods for calculating Medicare rebates, based on international pricing metrics rather than inflation-based metrics, reduce costs for Medicare fee-for-service (“FFS”) beneficiaries and the Medicare program while preserving quality of care.

The Guarding U.S.

Medicare Against Rising Drug Costs (“GUARD”) Model, would test an alternative approach to calculating rebates for certain Medicare Part D products using international pricing benchmarks.

The GUARD Model would begin on January 1, 2027, and run through December 31, 2033.

Further, on December 19, 2025, CMS proposed the Global Benchmark for Efficient Drug Pricing Model (“GLOBE”) for Medicare Part B, would require manufacturers of specified single source drugs and sole source biologics to pay incremental rebates based on international benchmark prices, with participation triggered for products meeting CMS’s spending and eligibility criteria.

As proposed, GLOBE would begin a five-year performance period on October 1, 2026.

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.

CMS also published a final rule to allow Medicare Advantage Plans the option of using step therapy for Part B drugs.

Further, CMS issued the CY 2026 Medicare Physician Fee Schedule final rule, effective January 1, 2026, which, among other things, restricts whether certain fees should be considered bona fide service fees, increases bona fide service fee documentation requirements, defines “bundled arrangement,” requires “unbundling” of both contingent and non-contingent discounts and includes sales of Part B units at the Maximum Fair Price in average sales price calculations.

These changes may reduce reimbursement for Medicare Part B utilization and require manufacturers to comply with new, complex and potentially uncertain reporting obligations and drug pricing documentation practices.

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 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.

Pursuant to court order, the removal and addition of the aforementioned safe harbors were delayed and recent legislation imposed a moratorium on implementation until January 1, 2032.

Implementation of this change and new safe harbors for point-of-sale reductions in price for prescription pharmaceutical products and PBM service fees are currently under review by the Biden administration and may be amended or repealed.

In addition, there have been several changes to the 340B drug pricing program, which imposes ceilings on prices that drug manufacturers can charge for medications sold to certain health care facilities.

In 2023, the U.S.

In November 2023, the U.S.

District Court of South Carolina issued an opinion in Genesis Healthcare Inc.

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that may lead to an expansion of the scope of patients eligible to access prescriptions at 340B pricing.

The outcome of this judicial proceeding is currently uncertain.

In December 2025, the U.S.

District Court of Maine issued a preliminary injunction blocking HHS from implementing the 340B rebate model pilot program, and HHS subsequently agreed to vacate the existing program so it could consider whether to proceed with a new administrative process for such a program.

At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

While much of the focus of state pricing policies is limited to Medicaid, we cannot assess the impact that these and other measures such as state transparency policies will have on our business.

Additionally, certain states are also pursuing cost containment efforts through Prescription Drug Affordability Boards (“PDABs”) and similar entities.

While many PDABs have been granted authority to promote drug price transparency and reporting, some states have granted PDABs more expansive authority, including to set Upper Payment Limits (UPLs) on select, high price drugs.

The adoption and implementation of UPLs may put downward pressure on drug prices and impact our company’s future revenues.

Healthcare Laws and Compliance Requirements

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or knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay money to the federal government.

In addition, the government may assert that a claim including items and services resulting from a violation of the federal AKS constitutes a false of fraudulent claim for purposes of the FCA.

In addition, the government may assert that a claim including items and services resulting from a violation of the federal AKS constitutes a false or fraudulent claim for purposes of the FCA.

The government may deem manufacturers to have “caused” the submission of false or fraudulent claims by, for example, providing inaccurate billing or coding information to customers or promoting a product off-label.

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It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations.

EU Regulation

EU Product Approval

The EMA is a decentralized scientific agency of the EU which coordinates the scientific evaluation and monitoring of centrally authorized medicinal products and is responsible for the scientific evaluation of applications for EU marketing authorizations, as well as the development of technical guidance and the provision of scientific advice to sponsors.

The EMA decentralizes its scientific assessment of medicines by working through a network of experts throughout the EU, nominated by the EU Member States.

The EC is responsible for formally granting centralized marketing authorizations in the EU, following the scientific opinion from the EMA.

The process regarding approval of medicinal products in the EU is similar to the process in the U.S.

and generally involves completing each of the following:

• preclinical laboratory tests, animal studies and formulation studies performed in accordance with the applicable EU GLP regulations;

• submission of a clinical trial authorization application (“CTA”) for each trial in humans through the EU Clinical Trials Information System (“CTIS”) to the competent authorities of the EU Member States concerned, which must be approved before the trial may begin in each EU Member State where patient enrollment is planned;

• performance of adequate and well-controlled clinical trials to establish the safety and efficacy of the product for each proposed indication;

• submission to the relevant competent authorities of a Marketing Authorization Application (“MAA”), which includes the data supporting safety and efficacy as well as detailed information on the manufacture and composition of the product in clinical development and proposed labeling;

• satisfactory completion of an inspection by the relevant national authorities of the manufacturing facility or facilities, including those of third parties, at which the product is produced to assess compliance with strictly enforced cGMP;

• potential audits of the non-clinical and clinical trial sites that generated the data in support of the MAA;

• review and approval by the relevant competent authority of the MAA before any commercial marketing, sale or shipment of the product.

Preclinical Studies and Clinical Trials

The conduct of preclinical tests and formulation of compounds for testing in the EU must comply with the relevant international, EU and national legislation, regulations and guidelines.

The results of the preclinical tests, together with relevant manufacturing information and analytical data, are submitted as part of the CTA.

Clinical trials of medicinal products conducted in the EU must comply with the harmonized regulatory framework provided by Regulation (EU) No 536/2014 (“Clinical Trials Regulation”), and the International Conference on Harmonization (“ICH”) guidelines on GCP.

A clinical trial to be conducted in an EU Member State must be authorized by the competent authority of the EU Member State concerned and given a positive opinion by an independent ethics committee in accordance with the Clinical Trials Regulation and applicable national laws.

The CTA must include, among other things, a copy of the trial protocol and an investigational medicinal product dossier containing information about the manufacture and quality of the medicinal product under investigation, and data derived from non-clinical studies and from its clinical use (if any).

The Clinical Trials Regulation, which became applicable in January 2022, establishes the procedure to enable sponsors to submit one CTA for it to be approved in a more streamlined and coordinated manner by two or more countries in the EU or European Economic Area (“EEA”) where the clinical trial is to be performed.

Sponsors are required to submit an application through an online platform known as the Clinical Trials Information System for approval.

To make it more efficient to carry out such multinational trials, one EU Member State assumes the role as the reporting Member State to lead the scientific review of the assessment, for agreement by the EU Member States concerned within the timeframe stipulated by the Clinical Trials Regulation.

Each concerned Member State is responsible for assessing country-specific issues concerning the clinical trial, including those related to adequacy of the trial sites, facilities and recruitment details.

One of the key objectives of the Clinical Trial Regulation is to strengthen the transparency of clinical trial related information.

Clinical trial data and information submitted to the CTIS are subject to public disclosure in accordance with the Clinical Trials Regulation, subject to defined exceptions, including for the protection of personal data, commercially confidential information, and confidential communications between Member States during the assessment process.

Manufacturers are afforded the opportunity to seek scientific advice from regulatory authorities to guide their research and development programs.

A request for scientific advice can be made nationally by engaging the national competent authorities or centrally, which is coordinated by the EMA at different stages of product development in relation to questions concerning an assessment of the product quality, non-clinical testing and clinical development.

Scientific advice is not binding with regard to any future MAA of the product concerned, but departure from the advice should be justified in the MAA.

Marketing Authorizations

After completion of the required clinical testing, we must obtain a marketing authorization before we can place a medicinal product on the market in the EU.

There are various marketing authorization procedures available, depending on the type of product involved.

All procedures require an application to be presented in the internationally harmonized Common Technical Document format, which includes the submission of detailed information about the manufacturing and quality of the product, and nonclinical testing and clinical trials, to inform the benefit-risk assessment.

The centralized procedure results in marketing authorizations that are valid throughout the EU and, by extension (after national implementing decisions), in Norway, Iceland and Liechtenstein, which, together with the EU Member States, comprise the EEA.

Applicants submit MAAs to the EMA, where they are reviewed by relevant scientific committees, including the Committee for Medicinal Products for Human Use (“CHMP”).

The EMA forwards the CHMP opinion to the EC, which adopts a decision granting or refusing a marketing authorization.

The centralized procedure is compulsory for medicinal products that (1) are developed by biotechnology processes, (2) are an advanced therapy medicinal product (i.e., gene therapy, somatic cell therapy or tissue-engineered medicines), (3) contain a new active substance indicated for the treatment of certain diseases, such as HIV/AIDS, cancer, diabetes, neurodegenerative disorders, viral diseases or autoimmune diseases and other immune dysfunctions or (4) are orphan medicinal products.

For medicines that do not fall within these categories, an applicant may voluntarily submit an application for a centralized marketing authorization to the EMA, provided that the medicine concerned contains a new active substance and the CHMP agrees that (i) the medicine is a significant therapeutic, scientific, or technical innovation, or (ii) the authorization of the medicine under the centralized procedure would be in the interest of public health at the EU level.

For those medicinal products for which the centralized procedure is not available, the applicant must submit MAAs to the national competent authorities of the EU Member States through one of three procedures:

(1) a national procedure, which results in a marketing authorization in a single EU Member State;

(2) the decentralized procedure, in which applications are submitted simultaneously in two or more EU Member States and a reference Member State is appointed to lead the scientific assessment;

or (3) the mutual recognition procedure, which is used when the product has already been nationally authorized in at least one EU Member State (the reference Member State), and the marketing authorization holder seeks recognition of that authorization for the same product in at least one other EU Member State (concerned Member States).

A concerned Member State may refuse to recognize the assessment of the reference Member State in the decentralized procedure or the mutual recognition procedure on grounds of potential serious risk to public health.

Under the centralized procedure in the EU, the maximum timeframe for the evaluation of an MAA is 210 days.

However, this timeline excludes clock stops, when additional written or oral information is to be provided by the applicant in response to questions asked by the CHMP, so the overall process typically may take a year or more.

Accelerated assessment may be granted by the CHMP in exceptional cases, when a medicinal product is expected to be of major interest for public health and therapeutic innovation.

In this circumstance, the EMA ensures that the opinion of the CHMP is given within 150 days, excluding clock stops.

Data Exclusivity

MAAs for generic medicinal products do not need to include the results of preclinical studies and clinical trials but instead can refer to such data included in the marketing authorization of a reference product for which regulatory data exclusivity has expired.

Where a marketing authorization is granted for a medicinal product containing a new active substance, that product benefits from eight years of data exclusivity, during which generic MAAs referring to the data of that product will not be accepted by the regulatory authorities, and a further two years of marketing protection, during which such generic products, even if approved, may not be placed on the market until the full 10-year protection period has expired.

The 10-year protection period may be extended to 11 years if, during the first eight years of the product’s authorization, one or more new therapeutic indications with significant clinical benefit over existing therapies are approved.

There is a special regime for biosimilars, or biological medicinal products that are similar to a reference medicinal product but that do not meet the definition of a generic medicinal product, for example, because of differences in raw materials or manufacturing processes.

For such products, the results of appropriate preclinical studies or clinical trials must be provided, and guidelines from the EMA detail the type of supplementary data to be provided for different types of biological product.

Orphan Designation

In the EU, an orphan medicinal product designation may be granted, following recommendation by the EMA’s Committee for Orphan Medicinal Products (“COMP”), for products that are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions affecting not more than five in 10,000 persons in the EU.

Additionally, designation may be granted for products intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition when, without incentives, it is unlikely that sales of the product in the EU would be sufficient to justify the necessary investment in developing the medicinal product.

The COMP may only recommend orphan designation when the product in question offers a significant clinical benefit over existing approved products for the relevant indication or where no satisfactory method of diagnosis, prevention or treatment of such condition exists.

Following a positive opinion by the COMP, the EC adopts a decision granting orphan status.

The COMP will reassess orphan status in parallel with EMA review of an MAA, and orphan status may be withdrawn at that stage if the product no longer fulfills the orphan criteria.

Orphan designation entitles a party to financial incentives such as reduction of fees or fee waivers, and 10 years of market exclusivity is granted following marketing authorization.

During this period, the EU competent authorities may not accept or approve a marketing authorization application for a similar medicinal product, meaning a medicinal product containing a similar active substance or substances as contained in an authorized orphan medicinal product and which is intended for the same approved therapeutic indication, unless:

(i) the second medicinal product is safer, more effective or otherwise clinically superior to the authorized orphan product;

(ii) the marketing authorization holder for the authorized product consents to a second application;

or (iii) the marketing authorization holder for the authorized product cannot supply enough orphan product.

This period may be reduced to six years if the orphan designation criteria are no longer met, including where it is shown that the product is sufficiently profitable not to justify maintenance of orphan designation.

PRIME Designation

The PRIority MEdicines (“PRIME”), scheme is intended to encourage product development in areas of unmet medical need and provides accelerated assessment of products representing substantial innovation reviewed under the centralized procedure.

Eligible products must target conditions for which there is an unmet medical need (there is no satisfactory method of diagnosis, prevention or treatment in the EU or, if there is, the new medicine will bring a major therapeutic advantage) and they must demonstrate the potential to address the unmet medical need by introducing new methods of therapy or improving existing ones.

Products from small- and medium-sized enterprises may qualify for earlier entry into the PRIME scheme than larger companies.

Many benefits accrue to sponsors of therapeutic candidates with PRIME designation, including but not limited to early and proactive regulatory dialogue with the EMA, frequent discussions on clinical trial designs and other development program elements, and potentially accelerated MAA assessment once a dossier has been submitted.

Importantly, a dedicated EMA contact and rapporteur from the CHMP are appointed early in the PRIME scheme facilitating increased understanding of the product at the EMA’s Committee level.

A kick-off meeting initiates these relationships and includes a team of multidisciplinary experts at the EMA to provide guidance on the overall development and regulatory strategies.

Where, during the course of development, a medicine no longer meets the eligibility criteria, support under the PRIME scheme may be withdrawn.

Post-Approval Controls

The holder of a marketing authorization must establish and maintain a pharmacovigilance system and appoint an individual qualified person for pharmacovigilance who is responsible for oversight of that system.

Key obligations include expedited reporting of suspected serious adverse reactions and submission of periodic safety update reports (“PSURs”).

All new MAAs must include a risk management plan describing the risk management system that the company will put in place and documenting measures that will be taken to prevent or minimize the risks associated with the product.

The regulatory authorities may also impose specific obligations as a condition of the marketing authorization.

Such risk-minimization measures or post-authorization obligations may include additional safety monitoring, more frequent submission of PSURs, or the conduct of additional clinical trials or post-authorization safety studies.

All advertising and promotional activities for the product must be consistent with the approved summary of product characteristics, and therefore all off-label promotion is prohibited in the EU.

Direct-to-consumer advertising of prescription medicines is also prohibited in the EU.

Although general requirements for advertising and promotion of medicinal products are established under EU directives, the details are governed by national law in each Member State and may differ between Member States.

Manufacturing

Medicinal products may only be manufactured in the EU, or imported into the EU from another country, by the holder of a manufacturing authorization from the competent national authority.

The manufacturer or importer must have a qualified person who is responsible for certifying that each batch of product has been manufactured in accordance with EU standards of cGMP before releasing the product for commercial distribution in the EU or for use in a clinical trial.

Manufacturing facilities are subject to periodic inspections by the competent authorities for compliance with cGMP.

Testing and certification on importation is exempted where there exists a Mutual Recognition Agreement between the exporting country and the EU.

Pricing and Reimbursement

Governments influence the price of medicinal products in the EU through their pricing and reimbursement rules and control of national healthcare systems that fund a large part of the cost of those products to consumers.

Some EU Member States operate positive or negative list systems under which reimbursed products may only be placed on the market once a reimbursement price has been agreed.

To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost-effectiveness of a particular product candidate to currently available therapies.

Other EU Member States allow companies to fix their own prices for medicines but monitor and control company profits.

The downward pressure on healthcare costs in general, particularly prescription medicines, has become intense.

In addition to an assessment of cost-effectiveness, the national health systems may consider whether market access is affordable.

As a result, increasingly high barriers are being erected to the entry of new products.

Reform of the Regulatory Framework in the EU

The EC introduced legislative proposals in April 2023 that, if implemented, will replace the current regulatory framework in the EU for all medicines (including those for rare diseases and for children).

In April 2024, the European Parliament adopted its position on the legislative proposals, and in June 2025, the Council of the European Union adopted its position.

A common position on the text was agreed upon in December 2025, in the context of subsequent inter-institutional trilogue negotiations.

The proposed revisions remain to be adopted and are not expected to become applicable before 2028.

The aforementioned EU rules are generally applicable in the EEA.

Brexit and the Regulatory Framework in the UK

Following the end of the Brexit transition period on January 1, 2021 and the implementation of the Windsor Framework on January 1, 2025, the UK is not generally subject to EU laws in respect of medicines.

EU laws that were transposed into UK law through secondary legislation continue to apply in the UK as retained EU law (as amended), but new EU legislation, such as the Clinical Trials Regulation, does not apply in the UK.

Since January 1, 2021, the Medicines and Healthcare products Regulatory Agency (“MHRA”) has been the UK’s standalone medicines and medical devices regulator .

Under the Medicines and Medical Devices Act 2021, the Secretary of State or an “appropriate authority” has delegated powers to amend or supplement existing regulations in the area of medicinal products and medical devices.

This allows new rules to be introduced in the future by way of secondary legislation, which aims to allow flexibility in addressing regulatory gaps and future changes in the fields of human medicines, clinical trials and medical devices.

The UK regulatory framework in relation to clinical trials is governed by the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended, which is derived from the EU Clinical Trial Directive, as implemented into UK national law through secondary legislation.

In April 2025, the UK introduced the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025.

These changes, which will take full effect from April 2026, aim to create a streamlined, risk-proportionate system that accelerates approvals while maintaining robust safety standards.

Marketing authorizations in the UK are governed by the Human Medicines Regulations (SI 2012/1916), as amended.

All existing EU marketing authorizations for centrally authorized products were automatically converted or grandfathered into UK marketing authorizations, effective in Great Britain only, on January 1, 2021, unless the marketing authorization holder chose to opt-out.

Under the terms of the Windsor Framework, these licenses became valid for the whole of the UK from January 1, 2025.

In order to use the centralized procedure to obtain a marketing authorization that will be valid throughout the EEA, companies must be established in the EEA.

Therefore, after Brexit, companies established in the UK can no longer use the EU centralized procedure and instead an EEA entity must hold any centralized marketing authorizations.

In order to obtain a UK marketing authorization to commercialize products in the UK, an applicant must be established in the UK and must follow one of the UK national authorization procedures or one of the remaining post-Brexit international cooperation procedures.

In the UK, the initial duration of a marketing authorization is five years and, following renewal, it will be valid for an unlimited period unless the MHRA decides on justified grounds relating to pharmacovigilance to proceed with only one additional five-year renewal.

Any authorization which is not followed by the actual placing of the medicine on the market in the UK within three years shall cease to be in force.

EU and UK Data Protection Laws

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 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.

The GDPR imposes a broad range of strict requirements on companies subject to the GDPR, including requirements to have legal basis for processing certain 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 where there is no other 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 includes substantial penalties to which we could become 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.

In addition, the UK’s European Union (Withdrawal) Act 2018 incorporated the GDPR (subject to certain UK specific amendments) into UK law, referred to as the UK GDPR.

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PRC Regulation

In the PRC, we operate in an increasingly complex legal and regulatory environment.

Our China operations are conducted by our Chinese subsidiaries owned by BeOne Medicines (Hong Kong) Co., Limited, one of our wholly owned subsidiaries.

We are subject to a variety of PRC laws, rules and regulations affecting many aspects of our business.

As a result of our operations in China, the Chinese regulatory authorities have significant influence over our conduct of business and may influence our operations as they deem appropriate to further economic, regulatory, political and societal goals.

This section summarizes the principal PRC laws, rules and regulations that we believe are relevant to our business and operations.

For a detailed description of risks related to our doing business in China, please refer to “Risk Factors—Risks Related to Our Doing Business in the PRC”.

PRC Drug Regulation

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The legal framework for the administration of pharmaceutical products in China was established by the Drug Administration Law of the PRC (the “DAL”).

The DAL provides a framework for regulating pharmaceutical manufacturers, pharmaceutical trading companies, medical institutions, and the research, development, manufacturing, distribution, packaging, pricing, and advertisement activities related to pharmaceutical products.

The Implementing Measures of the Drug Administration Law provides detailed implementation regulations for the DAL.

The DAL embodies a regulatory trend to strengthen the life-cycle management of drugs, to balance the development of innovative drugs and generic drugs, and to enhance drug review and enforcement.

It established the Marketing Authorization Holder (the “MAH”) system, and subject to approval by the NMPA, MAHs will be allowed to transfer their marketing authorizations.

The DAL established the Marketing Authorization Holder (the “MAH”) system, and subject to approval by the NMPA, MAHs will be allowed to transfer their marketing authorizations.

However, to date, it remains uncertain whether the transferability of MAH will offer more flexibility in structuring cross-border transactions.

In addition, the implementation of the MAH system was accompanied by a range of new requirements for the MAHs.

For example, a MAH must establish a quality assurance system and be responsible for the whole process and all aspects of preclinical research, clinical trials, manufacturing and distribution, post-marketing research, adverse drug reaction monitoring and reporting.

In addition, the implementation of the MAH system was accompanied by a range of new requirements for the MAHs, including establishing a quality assurance system and being responsible for all aspects of preclinical research, clinical trials, manufacturing and distribution, post-marketing research, adverse drug reaction monitoring and reporting.

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.

The DAL requires drug manufacturers and drug distributors to comply with current GMP and good supply practice (“GSP”) requirements.

Pursuant to the DAL, NMPA and its local counterparts are directed to strengthen their surveillance of drug manufacturers and distributors, including through regular site inspections and unannounced checks, to ensure their compliance.

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The DAL also requires MAHs, manufacturers, distributors, and medical institutions to establish and implement drug track and trace systems.

The Measures for the Quality Supervision of Drug Commercialization and Use established the requirements and standards for the drug track and trace system.

A drug pharmacovigilance system will also be established to monitor, identify, evaluate and control adverse drug reactions and other possible drug-related problems.

The Good Pharmacovigilance Practices provides detailed requirements on MAH’s pharmacovigilance obligations.

The DAL creates an expanded access pathway for investigational drugs under which a company sponsor of a clinical trial in China can apply to establish an expanded access treatment program for patients with life-threatening disease who otherwise do not satisfy the inclusion criteria of a clinical trial.

To quality for expanded access:

(1) the drug must be used for life-threatening diseases that lack effective treatment;

(2) the drug must have demonstrated its potential efficacy based on medical observations;

(3) such use is in line with ethical principles;

(4) such expanded use has been reviewed and approved (although the approval pathway not clear), and has obtained patients’ informed consent;

and (5) the drug must be used within the clinical trial institution and used on patients with similar conditions.

The DAL provides heavy penalties for violations.

Depending on various types of violations, the DAL imposes different penalties, including warnings, confiscation of illegal gains, fines of up to RMB5 million (about $725,000) or up to 30 times of illegal gains, revocation of required business and operating licenses, certificates or approval documents for drugs, suspension of business, temporary (10 years) or permanent debarment of companies, institutions and responsible persons, and criminal liabilities in the case of serious violations.

The interpretation and implementation of the DAL have been evolving overtime.

Depending on various types of violations, the DAL imposes different penalties, including warnings, confiscation of illegal gains, fines, revocation of required business and operating licenses, certificates or approval documents for drugs, suspension of business, temporary or permanent debarment of companies, institutions and responsible persons, and criminal liabilities in the case of serious violations.

The interpretation and implementation of the DAL have been evolving over time.

We plan to closely monitor the implementation of the DAL and its impact on our operations in China.

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In China, the NMPA is the primary regulator for pharmaceutical products and businesses.

It is a sub-agency of the State Administration for Market Regulation (the “SAMR”), which is responsible for, in addition to drug regulation, consumer protection, advertising, anticorruption, antitrust, fair competition and intellectual property.

The NMPA regulates almost all of the key stages of the life cycle of pharmaceutical products, including nonclinical studies, clinical trials, marketing approvals, manufacturing, advertising and promotion, distribution, and pharmacovigilance (i.e., post-marketing safety reporting obligations).

It is a sub-agency of the State Administration for Market Regulation (the “SAMR”), which is responsible for drug regulation, consumer protection, advertising, anticorruption, antitrust, fair competition and intellectual property.

The NMPA regulates almost all key stages of the life cycle of pharmaceutical products, including nonclinical studies, clinical trials, marketing approvals, manufacturing, advertising and promotion, distribution, and pharmacovigilance (i.e., post-marketing safety reporting obligations).

The CDE, which remains under the NMPA, conducts the technical evaluation of each drug and biologic application for safety and efficacy.

The NHC is China’s chief healthcare regulator.

It is primarily responsible for overseeing the operation of medical institutions (including clinical trial sites) and regulating the licensure of hospitals and other medical personnel.

The NHC is China’s chief healthcare regulator, primarily responsible for overseeing the operation of medical institutions (including clinical trial sites) and regulating the licensure of hospitals and other medical personnel.

The NHSA is the primary regulator overseeing national medical insurance and related drug reimbursement schemes, including, among others, the National Drug Reimbursement Price Negotiations, which have significant impact on innovative drugs’ prices in China.

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The DAL requires the NMPA to accredit GLP labs, and that nonclinical studies of chemical drug substances and preparations and biologics that are not yet marketed in China be conducted in GLP-certified labs.

There are no approvals required from the NMPA to conduct preclinical studies.

A Certificate for Use of Laboratory Animals is required for performing experimentation on animals under the Regulations for the Administration of Affairs Concerning Experimental Animals, the Administrative Measures on Good Practice of Experimental Animals, and the Administrative Measures on the Certificate for Experimental Animals (Trial).

Applicants for this certificate must satisfy a number of conditions, including (1) the environment and facilities for lab animals’ living and propagating must satisfy national requirements;

(2) lab animals must be qualified and sourced from institutions with Certificates for Production of Lab Animals;

and (3) the animals’ feeding and experimentation must be conducted by professionals, specialized and skilled workers, or other trained personnel.

Registration Categories

Prior to engaging with the NMPA on research and development and approval, an applicant will need to determine the registration category for its drug candidate (which will ultimately need to be confirmed with the NMPA), which will determine the requirements for its clinical trial and marketing application.

There are five categories for small molecule drugs:

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).

A Certificate for Use of Laboratory Animals is required for performing experimentation on animals under various regulations.

Applicants for this certificate must satisfy a number of conditions relating to facilities, sourcing, feeding and experimentation for lab animals.

Expedited Programs

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NMPA also permits conditional approval of certain medicines based on early phase data.

The agency has done this for medicines that meet unmet medical needs for life-threatening illnesses and also for medicines that treat orphan indications.

The agency has done this for medicines that meet unmet medical needs for life-threatening illnesses and for medicines that treat orphan indications.

Under the DRR, drugs that meet one of the three criteria might be eligible for conditional approval:

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or (3) vaccines that are urgently needed for major public health emergencies or otherwise deemed by the NHC to be urgently needed, and it is concluded upon evaluation that their benefits outweigh their risks.

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.

Following approval, the MAH is required to take risk mitigation measures and complete a post-marketing study as required by the NMPA within a prescribed timeline.

Breakthrough Therapy Designation

Breakthrough therapy designation (“BTD”) is a process designed to expedite the development and review of clinical stage, innovative or improved new drugs that meet the following criteria:

(1) they are intended to treat life threatening conditions or conditions that have serious negative impact on the quality of life, and (2) there are no effective treatment or preventive methods available, or there is preliminary clinical evidence indicating that they may demonstrate substantial improvement over available therapies.

(1) they are intended to treat life threatening conditions or conditions that have serious negative impacts on the quality of life, and (2) there are no effective treatment or preventive methods available, or there is preliminary clinical evidence indicating that they may demonstrate substantial improvement over available therapies.

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.

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Upon completion of preclinical studies and preliminary CMC studies, a sponsor typically needs to conduct clinical trials in China for registering a new drug.

The materials required for this application and the data requirements are determined by the registration category.

The data requirements and materials required for this application are determined by the registration category.

The NMPA has taken a number of steps to increase efficiency for approving clinical trial applications, and it has also significantly increased monitoring and enforcement of GCP to ensure data integrity.

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Domestically manufactured drugs are not subject to foreign approval requirements and the NMPA permits those drugs to conduct development via an IMCT as well.

The DAL has now also adopted an implied approval system for clinical trials of new drugs.

Trials can proceed if after 60 business days, the applicant has not received any objections from the CDE, as opposed to the lengthier previous clinical trial pre-approval process in which the applicant had to wait for affirmative approval.

The DAL also expands the number of trial sites by abolishing the GCP accreditation system and requiring trial sites to follow a more simplified notification procedure.

Clinical Trial Register

Clinical trials conducted in China must be registered and published through the Drug Clinical Trial Information Platform (http://www.chinadrugtrials.org.cn).

Applicants are required to pre-register the trial information within one month after obtaining the clinical trial approval to obtain the trial’s unique registration number and to complete registration of certain follow-up information before the first subject’s enrollment in the trial.

If the foregoing pre-registration and registration is not obtained within three years, the clinical trial approval automatically expires.

The DAL has adopted an implied approval system for clinical trials of new drugs.

Trials can proceed if after 60 business days, the applicant has not received any objections from the CDE.

In September 2025, the NMPA issued the Announcement on Optimizing the Review and Approval of Clinical Trial Applications for Innovative Drugs, which formally established an accelerated approval pathway for innovative drugs.

Under this regulation, the review timeline is compressed to 30 working days for certain innovative drugs that are designated as national priorities (including those for pediatric use or rare diseases) or are part of global simultaneous development programs.

This policy significantly expedites the regulatory timeline for eligible global innovative drug candidates.

Human Genetic Resources Regulation

The Regulation on the Administration of Human Genetic Resources (“HGR Regulation”) applies to all human genetic resources (“HGR”)-related activities for R&D purposes, including sampling, biobanking, use of HGR materials and associated data in China, and the provision or sharing of such materials or data with non-PRC parties.

As BeiGene, Ltd.

is a Cayman Islands company, we and our activities in China are subject to the HGR Regulation.

As we are a Swiss company, we and our activities in China are subject to the HGR Regulation.

Such non-PRC parties seeking access to China’s HGRs for scientific research, including clinical trials intended to support marketing approval of drugs and medical devices in China, must do so only through collaborations with Chinese parties, such as Chinese hospitals.

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As the joint ownership requirement is rather broad, it is unclear how this requirement will be implemented in practice.

The HGR Regulation also imposes severe penalties for various violations, including warnings, disgorgement of illegal gains, confiscation of illegal HGR, fines up to RMB10 million ($1,450,000) or 5-10 times of illegal gains in the event such illegal gains exceed RMB1 million ($145,000), and temporary (1-5 years) or permanent debarment of companies, institutions and responsible persons from future HGR projects regulated by the HGR Regulation.

The Implementing Rules for the HGR Regulation (the “HGR Implementing Rules”) provide several critical clarifications.

The HGR Regulation also imposes severe penalties for various violations, including warnings, disgorgement of illegal gains, confiscation of illegal HGR, fines, and temporary or permanent debarment of companies, institutions and responsible persons from future HGR projects regulated by the HGR Regulation.

The Implementing Rules for the HGR Regulation (the “HGR Implementing Rules”) provide several clarifications.

HGR data is narrowed down to cover only the data derived from HGR materials and gene-irrelevant clinical data, image data, protein data, and metabolic data are expressly excluded.

The use of the term non-PRC parties is also further clarified by elaborating that (1) “actual control” by non-PRC entities/individuals is interpreted to include not only being controlled through equity interests but also investment or contractual arrangements, which may cover variable interest entities (“VIEs”), and (2) companies incorporated in Hong Kong Special Administration Region (“SAR”) and Macau SAR but essentially controlled by Chinese domestic entities are not viewed as non-PRC parties.

The industry guidance provides more clarifications from practice perspective.

Notably, among others, (1) the non-PRC entity operating the electronic data capture system for an in-China trial is no longer regarded as a non-PRC party, (2) for gene-related scientific studies, if non-PRC entities do not substantively participate in such studies, nor obtain any study data, then such studies are no longer subject to the HGR regulation;

The industry guidance provides more clarifications from the practice perspective, including:

(1) the non-PRC entity operating the electronic data capture system for an in-China trial is no longer regarded as a non-PRC party;

(2) for gene-related scientific studies, if non-PRC entities do not substantively participate in such studies, nor obtain any study data, then such studies are no longer subject to the HGR regulation;

and (3) human urine, feces, blood plasma, and blood serum are expressly excluded from the scope of HGR materials.

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The NMPA has granted waivers for all or part of trials and stated that it will accept data generated abroad (even if not part of a global study), including early phase data, that meets its requirements.

The NMPA issued the Technical Guidance Principles on Accepting Foreign Drug Clinical Trial Data (the “Guidance Principles”), as one of the implementing rules for the Opinions on Deepening the Reform of the Evaluation and Approval Systems and Encouraging Innovation on Drugs and Medical Devices (the “Innovation Opinion”).

According to the Guidance Principles, data from foreign clinical trials must meet authenticity, completeness and accuracy requirements and such data must be obtained in compliance with the relevant requirements under the GCP of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.

Data from foreign clinical trials must meet authenticity, completeness and accuracy requirements.

Sponsors must be attentive to potentially meaningful ethnic differences in the subject population.

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Applicants for such conditional approvals will be required to establish a risk mitigation plan and may be required to complete trials in China after the drug is approved.

The CDE has developed a list of drugs that meet these criteria.

Clinical Trial Process and Good Clinical Practices

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Phase 3 (often the pivotal study) refers to clinical trials to further verify the drug candidate’s therapeutic efficacy and safety on patients with target indication(s) and ultimately provide sufficient evidence for the review of a drug registration application.

The NMPA requires that the different phases of clinical trials in China receive ethics committee approval (with exemptions for certain specific circumstances, such as studies utilizing public information or anonymized data) and comply with GCP.

The NMPA requires that the different phases of clinical trials in China receive ethics committee approval (with exemptions for certain specific circumstances and comply with GCP.

The NMPA conducts inspections on clinical trials conducted in China to assess GCP compliance and may refuse to approve the drug if it finds substantial issues in the trials.

In addition, upon granting the drug registration certificate, NMPA may, at its sole discretion, require a Phase 4 trial to be conducted by MAH within a specified period of time so as to further monitor and obtain safety and efficacy data of the drug.

Generic small molecule drugs are required to conduct a bioequivalence trial, in vitro studies or in some cases a clinical trial to demonstrate therapeutic equivalence to an innovator drug marketed either in China or abroad or an internationally accepted generic drug.

The NMPA has released catalogues of reference products, and it released first installment of a Marketed Drug List (China’s “Orange Book”) with information about drugs that may serve as reference products.

Pursuant to GCP, sponsors of clinical trials are responsible for proper packaging and labeling of drugs used for clinical trials, and in double-blinded clinical trials, the investigational drugs shall be consistent with the control drug or placebo in appearance, odor, packaging, labeling, and certain other features.

Pharmaceutical packaging must comply with national and professional standards.

If there is no national or professional standard available, companies may formulate and implement their own standards after obtaining the approval of the provincial administration for medical products or bureau of standards.

Changes in such approved packaging standards need to be re-approved.

Drugs of which the packaging standards are not approved shall not be released or marketed in China, except for those specifically supplied to the military.

In addition, upon granting the drug registration certificate, NMPA may, at its sole discretion, require a Phase 4 trial to be conducted by MAH within a specified period of time to further monitor and obtain safety and efficacy data of the drug.

New Drug Application (“NDA”) and Approval

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For domestically manufactured drugs, NDA sponsors must submit data derived from the submitted drugs in support of their approval.

Under the DAL, upon approval of the registration application, the NMPA will issue a drug registration certificate to the applicant which is in fact the marketing approval of the drug, and the applicant is no longer required to be equipped with relevant manufacturing capability.

Under the DAL, upon approval of the registration application, the NMPA will issue a drug registration certificate, or marketing approval of the drug, to the applicant, and the applicant is no longer required to be equipped with relevant manufacturing capability.

Manufacturing and Distribution

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This license must be renewed every five years, and the manufacturing facility is also required to comply with GMP.

MAHs holding a Type B DML are allowed to contract manufacturing and must undertake the quality management obligations.

NMPA has been increasing its regulatory oversight and control over contract manufacturing activities in China by way of imposing more specific and higher regulatory compliance requirements in terms of personnel, quality management system, and oversight of CMOs on MAHs.

For instance, NMPA released a Guidance on Onsite Inspection of Contract Manufacturing Activities by Drug MAHs in October 2023, in which over 60 inspection items are set for issuing and maintaining Type B DML.

Similarly, to conduct sales, importation, shipping and storage, a company must obtain a Drug Distribution License (“DDL”) from the local drug regulatory authority, subject to renewal every five years.

As with GMPs, companies are required to comply with GSP.

One exception is that the DAL and relevant implementation rules allow the MAH to conduct wholesales of its drugs directly without holding a separate DDL for wholesale, however, a retail DDL would still be required if the MHA intends to conduct direct retail to patients.

One exception is that the DAL and relevant implementation rules allow the MAH to conduct wholesales of its drugs directly without holding a separate DDL for wholesale.

China has developed a “Two-Invoice System” to control distribution of prescription drugs.

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Under the DAL, the MAH of a drug is ultimately responsible for pharmacovigilance, including quality assurance, adverse reaction reporting and monitoring, and product recalls.

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.

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.

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The definition of an advertisement is very broad and does not expressly exclude scientific exchange;

It can be any media that directly or indirectly introduces the product to end users.

There is no clear line between advertising and any other type of promotion.

an advertisement can be any media that directly or indirectly introduces the product to end users.

An enterprise seeking to advertise a prescription drug may do so only in medical journals jointly approved by NMPA and the NHC, and each advertisement requires approval from a local drug regulatory authority.

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Prescription drug advertisements are subject to strict content restrictions, which prohibit recommendations by doctors and hospitals and guarantees of effectiveness.

Advertising that includes content that is outside of the drug’s approval documentation (off-label content) is prohibited.

Advertising that includes content outside of the drug’s approval documentation (off-label content) is prohibited.

False advertising can result in civil suits from end users and administrative liability, including fines.

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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 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 amendments to the PRC Patent Law (the “Amended PRC Patent Law”) provide 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 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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National Reimbursement Drug List

China’s national medical insurance program currently consists of two fundamental sub-programs:

(1) the basic medical insurance program for urban employees, under which urban employers are required to enroll their employees in the program and the insurance premium is jointly contributed by the employers and employees;

and (2) the basic medical insurance program for urban and rural residents, which allows urban and rural residents who do not have employers to voluntarily participate in the basic medical insurance program and the insurance premium is jointly contributed by the participants and the government.

Participants of the national medical insurance program and their employers, if any, are required to contribute to the payment of insurance premiums on a monthly basis.

China’s national medical insurance program currently consists of two fundamental basic medical insurance sub-programs:

(1) for urban employees, under which urban employers are required to enroll their employees in the program and the insurance premium is jointly contributed by the employers and employees;

and (2) for urban and rural residents, which allows urban and rural residents who do not have employers to voluntarily participate in the basic medical insurance program and the insurance premium is jointly contributed by the participants and the government.

Program participants are eligible for full or partial reimbursement of the cost of medicines included in the NRDL.

A pharmaceutical product listed in the NRDL must be clinically needed, safe, effective, reasonably priced, easy to use, and available in sufficient quantity.

Factors that affect the inclusion of a pharmaceutical product in the NRDL include whether the product is used in large volumes and commonly prescribed for clinical use in the PRC and whether it is considered to be important in meeting the basic healthcare needs of the general public.

Historically, special consideration has been given to, among others, innovative drugs with high clinical value and drugs for serious diseases.

In addition, the government has also been negotiating with manufacturers of exclusive drugs with high clinical demands and proven effectiveness for price cuts in exchange for inclusion into the NRDL.

The version of the NRDL released in 2024 (effective from January 1, 2025) covers approximately 3,159 drugs in total, including 91 new drugs listed for which the prices were determined through negotiations between the drug companies and government.

China has been pursuing a policy of expediting the addition of innovative oncology drugs to this list.

REVLIMID has been included in the NRDL since 2017.

VIDAZA has been included in the NRDL since 2018.

BRUKINSA (zanubrutinib), tislelizumab, and XGEVA (120-mg denosumab) have been included in the NRDL since 2020.

PARP inhibitor PARTRUVIX (pamiparib) has been included in the NRDL since 2021.

KYPROLIS has been included in the NRDL since 2022.

SYLVANT and BAITUOWEI have been included in the NRDL since 2024.

KYPROLIS has been included in the NRDL since the beginning of 2023.

SYLVANT and BAITUOWEI have been included in the NRDL since the end of 2023.

To allow patients with commercial insurance earlier access to advanced treatments, the NHSA also introduced a Commercial Health Insurance Innovative Drug List (“CHIIDL”, effective as of January 1, 2026) in December 2025, which includes 19 high-value treatments not currently covered by the basic medical insurance fund.

ZIIHERA and QARZIBA have been included in CHIIDL since 2025.

Centralized Procurement and Tenders

Under current regulations, public medical institutions owned by the government or owned by state-owned or controlled enterprises are required to purchase pharmaceutical products through centralized online procurement processes.

There are exceptions for drugs on the National List of Essential Drugs, which must comply with their own procurement rules, and for certain drugs subject to the central government’s special control, such as toxic, radioactive and narcotic drugs, and traditional Chinese medicines.

The centralized procurement process takes the form of public tenders that are typically conducted once every year by provincial or municipal-level government agencies.

The bids are assessed by a committee randomly selected from a database of experts.

The committee members assess the bids based on a number of factors, including bid price, product quality, clinical effectiveness, product safety, level of technology, the manufacturer’s qualifications and reputation, after-sale services and innovation.

Since 2018, the government implemented a “zero markup” policy on all drugs among all public healthcare institutions nationwide.

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The Two-Invoice System, described above, is also designed to reduce price mark-ups brought about by multi-tier distribution chains.

Since 2019, the government adopted a volume-based, centralized drug procurement program to optimize the pricing of drugs.

Drugs are selected from generic brands for volume-based, centralized drug procurement.

The selected drugs must pass the bio-equivalence evaluation on quality and efficacy.

All approved enterprises that produce drugs on the procurement list in China may participate.

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

Pharmaceutical companies operating in China are subject to changing regulations under many other laws and regulations administered by governmental authorities at the national, provincial and municipal levels, some of which are or may become applicable to our business.

For example, regulations controlling the confidentiality of patient medical information and the circumstances under which patient medical information may be released for inclusion in our information systems or released by us to third parties.

Pharmaceutical companies operating in China are subject to changing regulations under many other laws and regulations administered by national, provincial and municipal governmental authorities, some of which are or may become applicable to our business.

For example, we are subject to regulations relating to labor and social insurance, product liability and the confidentiality of patient medical information and the circumstances under which patient medical information may be released for inclusion in our information systems or released by us to third parties.

The privacy of human subjects in clinical trials is also protected by privacy laws such as the Personal Information Protection Law.

These laws and regulations governing both the disclosure and the use of confidential patient medical information may become more restrictive in the future, including restrictions on transfer of healthcare data.

These laws and regulations governing both the disclosure and use of confidential patient medical information may become more restrictive in the future, including restrictions on transfer of healthcare data.

The Cybersecurity Law designates healthcare as a priority area that is part of critical information infrastructure, and China’s cyberspace administration has been working to finalize the regulatory regime on cross-border transfer of personal information.

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PRC Antitrust Regulation

China’s anti-trust regulatory regime is founded on the Anti-Monopoly Law (the “AML”) (last amended in 2022) and supplemented by several implementation rules.

China’s anti-trust regulatory regime is founded on the Anti-Monopoly Law (the “AML”) and supplemented by several implementation rules.

The AML in general restricts monopolistic practices including concentration of undertakings, horizontal and vertical monopolistic agreements, and certain activities of market dominance abuse.

The AML provides heavy penalties for violations, including warnings, confiscation of illegal gains, a fine ranging up to 50% of the preceding year’s turnover, revocation of required business and operating licenses, suspension of business, and even criminal liabilities.

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, 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

Under current law, a defective product which causes property damage or physical injury to any person may subject the manufacturer or vendor of such product to civil liability for such damage or injury.

Additionally, China’s Product Quality Law provides that manufacturers are liable for the quality of products produced by them, and sellers are required take measures to ensure the quality of the products sold by them.

A manufacturer is liable for compensating for any bodily injury or property damage resulting from product defects unless the manufacturer is able to prove that:

(1) the product was not distributed;

(2) the defects causing injury or damage did not exist at the time that the product was distributed;

or (3) science and technology at the time that the product was distributed was at a level incapable of detecting the defects.

A seller is liable for compensating for any bodily injury or property damage of others caused by the defects in the product if such defects are attributable to the seller.

A seller is required to pay compensation if it fails to indicate either the manufacturer or the supplier of the defective product.

A person who is injured or whose property is damaged by the defects in the product may claim compensation from the manufacturer or the seller.

The AML provides heavy penalties for violations, including warnings, confiscation of illegal gains, fines, revocation of required business and operating licenses, suspension of business, and even criminal liabilities.

The SAMR is the chief regulator of anti-trust law in China, and the pharmaceutical sector has been one of its focused enforcement areas for years.

Regulations Relating to Technology Export Control

Import and export of technologies for civilian use are regulated under the PRC Administrative Regulations on Technology Import and Export (the “TIER”).

Technology export is broadly defined under Chinese law to encompass any cross-border transfer of technologies from a Chinese entity to overseas – whether by way of patent assignments, patent licenses, software licenses, transfers of technical know-how, or the provision of technical services, or by any other means.

Technology export is broadly defined under Chinese law to encompass any cross-border transfer of technologies from a Chinese entity to overseas.

TIER divides technology export into the categories of (1) “prohibited” technologies, which cannot be exported outside China (2) “restricted” technologies, which requires approvals from the relevant Chinese authority, and (3) “unrestricted” technologies, which requires filing of proper transaction documents with the authority.

The “prohibited” and “restricted” technologies are defined by the Catalogue of Technologies Prohibited or Restricted from Export (the “Catalogue”).

The latest Catalogue, which was issued on December 21, 2023, included “cell cloning and gene editing technologies used in humans” into the prohibited list.

It still remains unclear how the Chinese government would eventually enforce such prohibition on technology control.

The latest Catalogue, issued in December 2023, included “cell cloning and gene editing technologies used in humans” into the prohibited list.

It remains unclear how the Chinese government would eventually enforce such prohibition on technology control.

We plan to closely monitor China’s legislative and regulatory evolvement in this area and its potential impact on our operations in China.

Regulations Relating to Commercial Bribery

Pharmaceutical companies involved in a criminal investigation or administrative proceeding related to bribery are listed in the Adverse Records of Commercial Briberies by the provincial health commissions.

If a pharmaceutical company or its agent is listed, public medical institutions located in the local provincial level region are prohibited from making any purchase from the company for two years.

Where a pharmaceutical company or its agent is listed in the adverse records on two or more occasions within five years, all public medical institutions in China are not permitted to purchase any products from that company for two years.

In January 2025, SAMR launched a first-of-its-kind Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks, which provide guidance for managing commercial bribery risks for healthcare and pharmaceutical companies and reflect the SAMR’s enforcement priorities and high-risk areas of focus observed in recent years.

Subject to the Credit Evaluation System for Pharmaceutical Pricing, Bidding and Procurement, the National Healthcare Security Administration has established a catalog of dishonest practices related to drug pricing and procurement through bidding, which will be dynamically adjusted.

The dishonest practices included in this catalog primarily encompass kickbacks or other improper benefits in the buying and selling of drugs, tax-related violations, monopolistic behaviors, improper pricing practices, disruption of centralized procurement processes, malicious breach of contracts, and other acts that contravene good faith principles.

Provincial centralized procurement agencies will take action against pharmaceutical companies based on their trustworthiness ratings.

Regulations Relating to Foreign Exchange

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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.

Furthermore, in 2019, SAFE issued the Circular of the State Administration of Foreign Exchange on Further Promoting the Facilitation of Cross-border Trade and Investment (“Circular 28”) which allows non-investment foreign-invested enterprises to use their capital funds to make equity investments in China, provided that such investments do not violate the effective Special Entry Management Measures for the Access of Foreign Investment (Negative List) and the target investment projects are genuine and in compliance with laws.

The interpretation and implementation of Circular 28 in practice are subject to substantial uncertainty.

or extending loans to non-related parties, unless permitted by the scope of business or located in the designated area.

Regulations Relating to Dividend Distributions

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Profits retained from prior fiscal years may be distributed together with distributable profits from the current fiscal year.

Labor Laws and Social Insurance

Under Chinese law, employers must execute written labor contracts with their full-time employees and must comply with local minimum wage standards.

Employers must establish a comprehensive management system to protect the rights of their employees, including a system governing occupational health and safety, and to truthfully inform prospective employees of the job description, working conditions, location, occupational hazards and status of safe production as well as remuneration and other conditions.

Violations of these requirements may result in the imposition of fines and other administrative and criminal liability in the case of serious violations.

In addition, employers must provide employees with welfare schemes covering pension insurance, unemployment insurance, maternity insurance, work-related injury insurance, medical insurance and housing funds.

These payments are made to local administrative authorities, and any employer who fails to contribute may be fined and ordered to pay the deficit amount within a stipulated time limit.

Regulations Relating to Overseas Listing

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Rest of World Regulation

For other countries outside of the U.S.

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.

For other countries outside of the U.S., the EU 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.

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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.

On March 30, 2022, the SEC added BeOne Medicines Ltd.

to its conclusive list of issuers identified under the HFCAA.

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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.

We are a holding company incorporated in Switzerland with operations primarily conducted through direct and indirect subsidiaries in the U.S., China, the UK 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 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.

Since formation in 2010, BeOne Medicines Ltd.

has raised over $10.8 billion in various public and private stock offerings, and has raised additional amounts from various borrowings, and beginning in Q3 2024, from cash flows from operations.

Of the amounts raised, (1) $2.1 billion and RMB20 billion have been transferred as capital contributions to its operating subsidiaries and (2) $1.2 billion and RMB1.9 billion are outstanding intercompany loans due from its operating subsidiaries as of December 31, 2025.

All biopharmaceutical patents previously owned by BeOne Medicines Ltd.

have been transferred to operating subsidiaries for further development and commercialization.

As of December 31, 2024, 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.

As of December 31, 2025, BeOne Medicines Ltd.

held $584 million in cash and cash equivalents which are available for future investment in its programs and operating subsidiaries.

The Company’s subsidiaries outside of China have cash and cash equivalents of $3.2 billion that may be permanently transferred to BeOne Medicines 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.

however, to date, BeOne Medicines Ltd.

has not received any dividends or distributions from its operating subsidiaries.

For further information on our intercompany flow of funds, please refer to (i) the sections titled “Liquidity and Capital Resources” and “Risk Factors—Risks Related to Our Doing Business in the PRC—We may rely on dividends and other distributions on equity paid by our PRC subsidiaries to fund any cash and financing requirements we may have, and any limitation on the ability of our PRC subsidiaries to make payments to us could have a material and adverse effect on our ability to conduct our business,” and (ii) our consolidated financial statements and the related notes included herein.

As of December 31, 2025, the Company has established a deferred tax liability of $30 million associated with potential withholding taxes in the U.S.

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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.

Please see the section titled “Liquidity and Capital Resources” for further discussion.

Further, our board of directors has adopted a dividend policy which provides that we currently intend to retain all available funds and earnings, if any, to fund the development and expansion of our business, and we do not anticipate paying any cash dividends in the foreseeable future.

Subject to applicable law and our amended and restated articles of association, any future determination to pay dividends will be made at the discretion of our board of directors and may be based on a number of factors, including our future operations and earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that our board of directors may deem relevant.

Subject to applicable law and our articles of association, any future determination to pay dividends must be approved in advance by our shareholders.

Our board of directors may propose a dividend to shareholders but cannot itself authorize the dividends.

Such recommendation by our board of directors may be based on a number of factors, including our future operations and earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that our board of directors may deem relevant.

This dividend policy reflects our board of directors’ current views on our financial and cash flow position.

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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.

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The government adopted regulations in 2018 which stipulate that in determining whether a non-resident enterprise has the status as a beneficial owner, comprehensive analysis shall be conducted based on the factors listed therein and the actual circumstances of the specific case shall be taken into consideration.

Specifically, it expressly excludes an agent or a designated payee from being considered as a “beneficial owner.” We own the PRC subsidiaries through BeiGene (Hong Kong) Co., Limited (“BeiGene HK”).

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.

Specifically, it expressly excludes an agent or a designated payee from being considered as a “beneficial owner.” We own the PRC subsidiaries through BeOne Medicines (Hong Kong) Co., Limited (“BeOne HK”).

BeOne 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 and Securities Offerings

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In addition, capital contributions and intercompany loan arrangements are subject to local jurisdiction and banking regulations.

BeiGene, Ltd.

BeOne Medicines Ltd.

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 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 years ended December 31, 2024 and 2023.

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.

(“BeiGene UK”) and/or BeiGene Switzerland and their respective operating subsidiaries through intercompany fund advances and capital contributions.

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 years ended December 31, 2024 and 2023.

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.

• Cash may be transferred between BeOne HK and its operating subsidiaries in mainland China through intercompany loans and capital contributions.

Cash generated from BeOne HK is used to fund operations of its subsidiaries, and no funds were transferred from BeOne HK’s subsidiaries in mainland China to fund operations of other BeOne subsidiaries outside of mainland China for the years ended December 31, 2025 and 2024.

For the years ended December 31, 2025 and 2024, the amount of cash transferred between BeOne HK and its subsidiaries in mainland China was $95 million and $106 million, respectively.

• Cash may be transferred between BeOne Medicines UK, Ltd.

(“BeOne UK”) and/or BeOne Medicines I GmbH (“BeOne Switzerland”) and their respective operating subsidiaries through intercompany fund advances and capital contributions.

There are currently no restrictions on transferring funds between BeOne UK or BeOne Switzerland and their respective operating subsidiaries.

Cash generated from BeOne UK and BeOne Switzerland may be used to fund operations of their respective subsidiaries, and no funds were transferred from BeOne UK’s subsidiaries or from BeOne Switzerland’s subsidiaries to fund operations of other BeOne subsidiaries (such as BeOne HK and its subsidiaries in mainland China) for the years ended December 31, 2025 and 2024.

For the years ended December 31, 2025 and 2024, the amount of cash transferred between BeOne UK to its respective subsidiaries was $5 million and $142 million, respectively.

For the years ended December 31, 2025 and 2024, the amount of cash transferred between BeOne Switzerland to its respective subsidiaries was nil.

Seasonality of Business

Our global business has historically been subject to seasonality due to the dynamics of each market.

For example, in the U.S., our fourth quarter results are affected by customer buying patterns influenced by pricing dynamics, with a corresponding offset to our first quarter results from these inventory management practices by our distributors.

Net pricing and demand are also impacted in the U.S.

in the first quarter due to patient co-pays and deductibles resetting at the beginning of each year.

However, there are no assurances that these historical trends will continue in the future.

Human Capital Resources

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and Anti-Corruption Policy.

At BeiGene, empowering our people begins with our culture and values:

At BeOne, empowering our people begins with our culture and values:

Bold Ingenuity, Collaborative Spirit, Driving Excellence, and most importantly, Patients First.

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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.

As of February 13, 2026, we had nearly 12,000 full-time employees worldwide, across six continents, with approximately 1,900 employees in the U.S.

and the balance outside of the U.S.

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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.

Innovating Sustainably - We aim to assess and mitigate our impact on the environment to 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;

Within each focus area, we have identified key strategic priorities and have set targets where meaningful and appropriate.

These 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.

We report our progress in April of each year, and our reports can be found on our corporate website.

Financial Information

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Corporate Information

We are an exempted company incorporated on October 28, 2010 in the Cayman Islands with limited liability.

Any company that is registered in the Cayman Islands but conducts business mainly outside of the Cayman Islands may apply to be registered as an exempted company.

Our current registered office in the Cayman Islands is located at the offices of Mourant Governance Services (Cayman) Limited, 94 Solaris Avenue, Camana Bay, Grand Cayman KY1-1108, Cayman Islands.

Our website address is www.beigene.com.

We are a Swiss corporation with our registered office in Switzerland located at Basel, Canton of Basel-Stadt, Switzerland.

Our website address is www.beonemedicines.com.

We do not incorporate the information on or accessible through our website into this Annual Report, and you should not consider any information on, or that can be accessed through, our website as part of this Annual Report.

We own various registered trademarks, trademark applications and unregistered trademarks and service marks, including the name “BeiGene” and our corporate logo.

We own various registered trademarks, trademark applications and unregistered trademarks and service marks, including the name “BeOne” and our corporate logo.

All other trade names, trademarks and service marks of other companies appearing in this Annual Report are the property of their respective holders.

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We also make available, free of charge on our website, the reports filed with the SEC by our executive officers, directors and 10% shareholders pursuant to Section 16 under the Exchange Act.

Additionally, we make available on our website our securities filings with the HKEx and the Shanghai Stock Exchange.

Additionally, we make available on our website our securities filings with the HKEx and the SSE.

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.

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.

From time to time, we may use our website, our X account at x.com/BeOneMedicines, our LinkedIn account at linkedin.com/company/BeOneMedicines, our Facebook account at facebook.com/BeOneMedicines, and our Instagram account at instagram.com/BeOneMedicines to disclose material information and to comply with our disclosure obligations under Regulation FD.

Our financial and other material information is routinely posted to and accessible on the Investors section of our website, available at www.beonemedicines.com.

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.

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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