What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2026-04-03 compared with 2025-04-01 · 162 added, 136 removed, 205 unchanged (59% of the section changed)

About Sunshine Biopharma

are a pharmaceutical company offering and researching life-saving medicines in a wide variety of therapeutic areas, including

oncology and antivirals.

We are a pharmaceutical company offering and researching

life-saving medicines in a wide variety of therapeutic areas, including oncology and antivirals.

We have two wholly owned subsidiaries:

(i) Nora Pharma Inc.

(“Nora Pharma”), a Canadian

corporation, through which we currently have 70 generic prescription drugs on the market in Canada, and (ii) Sunshine Biopharma

(“Sunshine Canada”), a Canadian corporation which develops and sells OTC supplements.

(“Nora Pharma”), a Canadian corporation, through which we currently have 71 generic prescription drugs

on the market in Canada, and (ii) Sunshine Biopharma Canada Inc.

(“Sunshine Canada”), a Canadian corporation which develops

and sells OTC supplements.

In addition, we are conducting a proprietary drug

6 unchanged sentences

various types of strategic arrangements, including:

· In-licensing

and Supply Agreements:

Nora Pharma acquires the rights to import, market, sell and distribute

the products in Canada by purchasing the drug dossiers from strategic partners.

then files the dossiers with Health Canada to obtain regulatory approval prior to marketing.

In-licensing and Supply Agreements:

Nora Pharma acquires the rights to import, market, sell and distribute the products in Canada by purchasing the drug dossiers from strategic partners.

Nora Pharma then files the dossiers with Health Canada to obtain regulatory approval prior to marketing.

The approval process at Health Canada takes on average of 12 months.

The products are sold

under Nora Pharma label.

The products are sold under Nora Pharma label.

Cross-licensing:

Nora Pharma acquires the rights to import, market, sell and distribute the products in Canada

by receiving an authorization letter from pharmaceutical partners.

The partners’ products

are already approved in Canada but we are still required to obtain our own approval from

Health Canada, which takes on average 45-60 days.

The products are sold under Nora Pharma

· Distribution

Nora Pharma acquires the rights to market, sell and distribute the products

in Canada by signing a distribution agreement with pharmaceutical partners.

The partners’

products are already approved by Health Canada.

The products are sold under the partners’

Generic drugs are pharmaceutically equivalent

to the brand name drugs.

Nora Pharma acquires the rights to import, market, sell and distribute the products in Canada by receiving an authorization letter from pharmaceutical partners.

The partners’ products are already approved in Canada but we are still required to obtain our own approval from Health Canada, which takes on average 45-60 days.

The products are sold under Nora Pharma label.

Distribution Agreements:

Nora Pharma acquires the rights to market, sell and distribute the products in Canada by signing a distribution agreement with pharmaceutical partners.

The partners’ products are already approved by Health Canada.

The products are sold under the partners’ label.

Generic drugs are pharmaceutically equivalent to

the brand name drugs.

They contain identical medicinal ingredients in the same amounts as the brands.

Generic medications, however,

may have different non-medicinal ingredients than the brand name drugs, but the generic developer must show that these do not affect the

safety, efficacy, or quality of the drug compared to the brand.

When a generic drugs company wants to sell a generic drug in Canada, it

must file a generic drug submission with Health Canada.

Generic medications may have different non-medicinal ingredients than the brand name drugs, but the generic developer must show that these do not affect the safety,

efficacy, or quality of the drug compared to the brand.

When a generic drugs company wants to sell a generic drug in Canada, it must file

a generic drug submission with Health Canada.

The submission is called an Abbreviated New Drug Submission (ANDS).

The submission

is reviewed by scientists and health care experts at Health Products and Food Branch (HPFB) of Health Canada.

All generic drug submissions

go through the same process as the brand name drug submissions.

If the evaluation shows that the generic drug meets all regulatory requirements

(including patent and data protection considerations), Health Canada will issue a Notice of Compliance (NOC) and a Drug Identification

Number (DIN) to the applicant.

The NOC and DIN signal the drug's official approval in Canada and permit the applicant to market the drug

Once a company obtains the NOC and DIN for a drug, then it begins the process with Pan-Canadian Pharmaceutical Alliance (pCPA)

in order to have the drug listed on the provincial and territorial formularies and federal government drug benefit plans.

We currently have the following

generic prescription drugs on the market in Canada:

Action/Indication/Therapeutic

Reference/Brand

The submission is reviewed

by scientists and health care experts at Health Products and Food Branch (HPFB) of Health Canada.

All generic drug submissions go through

the same process as the brand name drug submissions.

If the evaluation shows that the generic drug meets all regulatory requirements (including

patent and data protection considerations), Health Canada will issue a Notice of Compliance (NOC) and a Drug Identification Number (DIN)

to the applicant.

The NOC and DIN signal the drug's official approval in Canada and permit the applicant to market the drug in Canada.

Once a company obtains the NOC and DIN for a drug, then it begins the process with Pan-Canadian Pharmaceutical Alliance (pCPA) in order

to have the drug listed on the provincial and territorial formularies and federal government drug benefit plans.

We currently have the following generic prescription

drugs on the market in Canada:

Therapeutic Area

Cardiovascular

12 unchanged sentences

Antibacterial

Gastroenterology

Central nervous system

Antibacterial

Central nervous system

2 unchanged sentences

Cardiovascular

Central nervous system

Hydroxychloroquine

Central nervous system

Hydroxychloroquine

Levetiracetam

11 unchanged sentences

Central nervous system

Pegfilgrastim

Cardiovascular

18 unchanged sentences

Anticonvulsant

Tramadol Acetaminophen

Central nervous system

Cholelithiasis

2 unchanged sentences

Central nervous system

through distribution agreements in which we act as distributor.

addition to the 70 drugs currently on the market, we have 64 additional drugs in our pipeline including 13 we anticipate launching

during the remainder of 2025.

These additional drugs will address various human health areas including cardiovascular, oncology,

gastroenterology, central nervous system, diabetes, urology, endocrinology, anti-infective, and anti-inflammatory.

believe the addition of these products to our existing portfolio will strengthen our presence in the Canadian $9.7 billion a year generic

drugs market ( Research and Markets ) and provide us with greater access to pharmacies as we become more of a go-to supplier for

every-day and specialty medicines.

Central nervous

*Sold through distribution agreements in which we act as distributor.

In addition to the 71 drugs currently on the market,

we have 22 additional drugs in our pipeline including 12 we anticipate launching during the remainder of 2026.

These additional drugs

will address various human health areas including cardiovascular, oncology, gastroenterology, central nervous system, diabetes, urology,

endocrinology, anti-infective, and anti-inflammatory.

We believe the addition of these products to our

existing portfolio will strengthen our presence in the Canadian $10.4 billion a year generic drugs market ( IMARC Group ) and provide

us with greater access to pharmacies as we become more of a go-to supplier for every-day and specialty medicines.

Research and Development

1 unchanged sentence

drugs in development:

Area/Indication

Drug Candidate

Therapeutic Area/Indication

Development Stage

K1.1 (mRNA LNP)

33 unchanged sentences

only in Betacoronaviruses, the subgroup of Coronaviruses represented by the highly pathogenic SARS-CoV, MERS-CoV, and SARS-CoV-2.

Our Anti-Coronavirus research effort has been focused

on developing an inhibitor of PLpro and, on May 22, 2020, we filed a patent application in the United States covering composition subject

matter pertaining to small molecules for inhibition of the Coronavirus PLpro as well as Mpro.

Our Anti-Coronavirus research effort has been focused on developing an

inhibitor of PLpro and, on May 22, 2020, we filed a provisional patent application in the United States covering composition subject matter

pertaining to small molecules for inhibition of the Coronavirus PLpro as well as Mpro.

Our provisional patent application, entitled Inhibitors

of Coronavirus Protease , was converted into a PCT patent application on April 30, 2021.

On December 23, 2025, we received a Notice

of Allowance from the USPTO for our PCT patent application.

Full patents are typically issued by the USPTO 4 to 8 weeks following the

issuance of the Notice of Allowance and payment of the issue fees.

In February 2022, we expanded our PLpro inhibitors

10 unchanged sentences

license agreement with the University of Arizona for all of the technology related to the Research Project.

have since broadened our objective to include the development of a first-in-class PLpro inhibitor to treat SARS-CoV2 and potentially

SARS-CoV and MERS-CoV infection in patients who could not use Paxlovid, Molnupiravir, or Remdesivir, due to concerns about drug interactions

and possible rebound infections and other side effects.

current lead compound was recently found to be active at sub micromolar concentrations against PLpro and exhibited antiviral

activity in SRAS-CoV-2 infected cells as well as in cells infected with several different variants of concern.

In addition, our

compound had favorable pharmacokinetics properties in rodent species and exhibited preferred drug accumulation in the lungs over

The compound was found to be orally active in a K18-human-ACE2 transgenic mouse model and to significantly reduce virus load

in the lungs of infected animals in a dose-dependent manner without gross toxicities.

In August 2024, we published

these and other research results related to this project in the Journal of Medicinal Chemistry ( J.

We have since broadened our objective to include

the development of a first-in-class PLpro inhibitor to treat SARS-CoV2 and potentially SARS-CoV and MERS-CoV infection in patients who

could not use Paxlovid, Molnupiravir, or Remdesivir, due to concerns about drug interactions and possible rebound infections and other

side effects.

Our current lead compound has been found to

be active at sub micromolar concentrations against PLpro and exhibited antiviral activity in SRAS-CoV-2 infected cells as well as in

cells infected with several different variants of concern.

In addition, our compound had favorable pharmacokinetics properties in

rodent species and exhibited preferred drug accumulation in the lungs over plasma.

The compound was found to be orally active in a

K18-human-ACE2 transgenic mouse model and to significantly reduce virus load in the lungs of infected animals in a dose-dependent

manner without gross toxicities.

In August 2024, we published these and other research results related to this project in the

Journal of Medicinal Chemistry ( J.

2024, 67, 13681−13702 ).

A copy of this article is available on our website at:

A copy of this article is available on our

www.sunshinebiopharma.com/scientific-publications.

Additional research results on our lead compound have recently been submitted for publication in the Journal

of Medicinal Chemistry and the research article has been peer-reviewed and is currently in press.

Intellectual Property

On May 22, 2020, we filed a provisional patent

application in the United States for a new treatment for Coronavirus infections.

Our patent application covers composition subject matter

pertaining to small molecules for inhibition of the main Coronavirus protease, Mpro, an enzyme that is essential for viral replication.

On May 22, 2020, we filed a provisional patent application in the United

States for a new treatment for Coronavirus infections.

Our patent application, entitled Inhibitors of Coronavirus Protease , covers

composition subject matter pertaining to small molecules for inhibition of the main Coronavirus protease, Mpro, an enzyme that is essential

for viral replication.

The patent application has a priority date of May 22, 2020.

On April 30, 2021, we filed a PCT application containing new research results

and extending coverage to include the Coronavirus Papain-Like protease, PLpro.

The priority date of May 22, 2020 has been maintained in

the newly filed PCT application.

On April 30, 2021, we filed a PCT application containing

new research results and extending coverage to include the Coronavirus Papain-Like protease, PLpro.

The priority date of May 22, 2020

has been maintained in the newly filed PCT application.

On December 23, 2025, we received a Notice of Allowance from the USPTO for our

PCT patent application.

Full patents are typically issued by the USPTO 4 to 8 weeks following the issuance of the Notice of Allowance

and payment of the issue fees.

On April 20, 2022, we filed a provisional patent

4 unchanged sentences

worldwide licensee of the University of Arizona for three (3) patents related to small molecules which inhibit the Coronavirus protease,

Our wholly owned subsidiary, Nora Pharma,

owns 200 DIN’s issued by Health Canada for prescription drugs currently on the market in Canada.

These DIN’s were

secured through in-licenses or cross-licenses from international manufacturers of generic pharmaceutical products.

Nora Pharma also

owns the rights to sell 10 generic prescription drugs in Canada through distribution agreements with various international partners

under which Nora Pharma acts as distributor and receives a percentage of sales.

Our wholly owned subsidiary, Nora Pharma, owns

200 DIN’s issued by Health Canada for prescription drugs currently on the market in Canada.

These DIN’s were secured through

in-licenses or cross-licenses from international manufacturers of generic pharmaceutical products.

Nora Pharma also owns the rights to

sell 10 generic prescription drugs in Canada through distribution agreements with various international partners under which Nora Pharma

acts as distributor and receives a percentage of sales.

In addition, we own four (4) NPN’s issued

2 unchanged sentences

us to manufacture and sell the OTC product, L-Citrulline, and (iv) NPN 80127436 which authorizes us to manufacture and sell the OTC product,

On September 30, 2025, we received official trademark

registration from the United States Patent and Trademark Office (Registration No.

7,963,385) for “Sunshine Biopharma Inc.”

On November 10, 2025, we received confirmation

of from the Canadian Intellectual Property Office of Canadian trademark registration (Registration No.

TMA1,056,964 and TMA1,056,969)

for “Sunshine Biopharma Inc.” and Design.

Government Regulations

23 unchanged sentences

The same grant the applicant marketing authorization

In the case of Nora Pharma’s products, Nora Pharma secures cross-licenses from supply partners holding NOC’s and

in turn applies to Health Canada to obtain DIN’s issued in Nora Pharma’s name in order to commercialize in Canada.

the pan-Canadian Pharmaceutical Alliance (pCPA), an alliance of the provincial, territorial and federal governments that collaborates

on a range of public drug plan initiatives to increase and manage access to clinically effective and affordable drug treatments, determines

generic drugs pricing based on a percentage of the brand-name reference products.

In the area of proprietary drug development where

our Anti-Coronavirus and Anti-Cancer compounds fall, we will be subject to significant regulations in the U.S.

in order to obtain approval

of the FDA to offer our products for sale when ready.

The procedure for obtaining FDA approval involves an initial filing

of an IND application following which the FDA would review and allow for the drug developer to proceed with Phase I clinical trials.

completion of Phase I, the results are filed with the FDA and a request is made to proceed to Phase II.

Similarly, following completion

of Phase II the data are filed with the FDA and a request is made to proceed to Phase III.

Following completion of Phase III, a new

drug application, or NDA is submitted and a request is made for marketing approval.

Depending on various issues and considerations, the

FDA could provide “emergency use authorization” or limited approval for “compassionate-use” if the drug treats

terminally ill patients with limited or no other treatment options available.

As of the date of the filing of this report, we have not

made any filings with the FDA or other regulatory bodies in other jurisdictions in connection with our proprietary drugs in development.

Nora Pharma secures cross-licenses from supply partners holding NOC’s

and in turn applies to Health Canada to obtain DIN’s issued in Nora Pharma’s name in order to commercialize the products in

Canada under the Nora Pharma label.

In Canada, the pan-Canadian Pharmaceutical Alliance (pCPA), an alliance of the provincial, territorial

and federal governments that collaborates on a range of public drug plan initiatives to increase and manage access to clinically effective

and affordable drug treatments, determines generic drugs pricing based on a percentage of the price of the brand-name reference products.

In the area of proprietary drug development

where our Anti-Coronavirus and Anti-Cancer compounds fall, we will be subject to significant regulations in the U.S.

obtain approval of the FDA to offer our products for sale.

The procedure for obtaining FDA approval involves an initial

filing of an IND application following which the FDA would review and allow for the drug developer to proceed with Phase I clinical

Following completion of Phase I, the results are filed with the FDA and a request is made to proceed to Phase II.

following completion of Phase II the data are filed with the FDA and a request is made to proceed to Phase III.

Following completion

of Phase III, a new drug application, or NDA is submitted and a request is made for marketing approval.

Depending on various issues

and considerations, the FDA could provide “emergency use authorization” or limited approval for

“compassionate-use” if the drug treats terminally ill patients with limited or no other treatment options available.

of the date of the filing of this report, we have not made any filings with the FDA or other regulatory bodies in other

jurisdictions in connection with our proprietary drugs in development.

In respect of OTC supplements, the FDA regulates

11 unchanged sentences

at varying costs.

currently do not have any proprietary drugs on the market.

Research quantities of our proprietary drug candidates are manufactured at

the University of Arizona located in Tucson, Arizona (Anti-Coronavirus compounds) and WuXi App Tech located in Hong Kong, China (K1.1

OTC products are manufactured under contract by INOV Pharma Inc.

At present, approximately 75% of the drugs in our products portfolio are manufactured by three (3) suppliers overseas.

We currently do not have any proprietary drugs

on the market.

Research quantities of our proprietary drug candidates are manufactured at the University of Arizona located in Tucson,

Arizona (Anti-Coronavirus compounds) and WuXi App Tech located in Hong Kong, China (K1.1 mRNA).

Our OTC products are manufactured under contract

by INOV Pharma Inc.

located in Montreal, Canada.

Marketing and Sales

generic drugs are currently being sold in Canada in the province of Quebec, and to a much lesser extent in the provinces of Ontario,

2 unchanged sentences

our marketing team provides human resources, commercial and technical assistance, as well as training and educational support to pharmacy

OTC products are currently sold in the U.S.

and Canada through Amazon.com and Amazon.ca, respectively.

Our personnel, together with outside

consultants develop and place ads on various media platforms and manage our accounts with Amazon.

to Research and Markets , the Canadian generic pharmaceuticals market was valued at approximately $9.7 billion USD in 2023 and

is expected to grow at a compound annual growth rate (CAGR) of 7.9%, reaching $19.2 billion USD by the end of 2032.

Generic pharmaceutical

companies produce and deliver more than 70% of the prescribed medicines with high quality at affordable prices.

There are more than 35

active generic players in the Canadian market, of which, the top 3 hold approximately 50% share of the total market.

Nora Pharma is relatively

new in this space but has demonstrated one of the fastest year-over-year sales growth amongst its peers.

We believe these pharmacy support activities, which we provide mostly free of charge, enhance our visibility in the marketplace

and bolster our sales efforts.

OTC products are sold in Canada exclusively through the Amazon marketplace, and until the third quarter of 2025, were also sold in the

United States exclusively through the Amazon marketplace.

In Q3 2025, we discontinued our Amazon sales operations in the United States.

We rely on Amazon’s infrastructure for order processing, fulfillment, and customer service.

Prior to our discontinuation of sales

operations in the United States, revenue from OTC product sales was derived approximately 10% from the United States and 90% from Canada.

Our personnel, together with outside consultants develop and place ads on various media platforms and manage our Amazon.ca account.

According to IMARC Group , the Canadian generic

pharmaceuticals market was valued at approximately $10.4 billion USD in 2024 and is expected to grow to $19.7 billion USD by 2033.

pharmaceutical companies produce and deliver more than 70% of the prescribed medicines with high quality at affordable prices.

more than 35 active generic players in the Canadian market, of which, the top 3 hold approximately 50% share of the total market.

Pharma is relatively new in this space but has demonstrated one of the fastest year-over-year sales growth amongst its peers.

Our Anti-Coronavirus drug development project is

11 unchanged sentences

such as the one we are developing which targets a different part of the virus could potentially form an important component of the range

of anti-coronavirus treatment options available to attending physicians.

of anti-coronavirus treatment options available to physicians.

In the area of anticancer drug development, we

1 unchanged sentence

There are numerous other entities

engaged in oncology therapeutics development that have greater resources than the resources presently available to us.

engaged in oncology therapeutics development that have greater resources than us.

Nearly all major

6 unchanged sentences

As of the date of this report, we believe Essential•9™ is the only Essential

Amino Acid product that comprises all 9 essential amino acids in capsule form.

of the date of this report we have a total of 52 employees.

our proprietary drug development activities are subcontracted out to specialized service providers in the U.S., Canada and overseas.

We also use consultants for various other activities including marketing, accounting, and IT.

laws in Quebec provide for certain guaranteed minimum entitlements, including minimum wages, maternity leave, medical leave, employee

termination conditions, and other similar benefits.

Moreover, the Province of Quebec has various language laws governing language use.

These laws require corporate operations carried out in the Province of Quebec to be conducted to a large extent, and in some cases entirely,

Amino Acid supplement that comprises all 9 essential amino acids in capsule form.

As of the date of this report, we have a total of

50 employees, all of whom are full-time.

Presently, our proprietary drug development activities

are subcontracted out to specialized service providers in the U.S., Canada and overseas.

We also use consultants and outside professionals

for various other activities including marketing, accounting, and IT.

Labor laws in the Province of Quebec provide for

certain guaranteed minimum entitlements, including minimum wages, maternity leave, medical leave, employee termination conditions, and

other similar benefits.

Moreover, the Province of Quebec has various language laws governing language use in the workplace.

require corporate operations carried out in the Province of Quebec to be conducted to a large extent, and in some cases entirely, in French.

We and our Canadian subsidiaries operating in the Province of Quebec are fully compliant with these laws.

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