NASDAQ: SBFMW
Sunshine Biopharma Inc.CIK 0001402328 · Pharmaceutical Preparations
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 71 generic… About this business →
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About Sunshine Biopharma Inc.
Source: Item 1 (Business) from the 10-K filed April 3, 2026. Description as filed by the company with the SEC.
ITEM 1. BUSINESS
About Sunshine Biopharma
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 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
development program which is comprised of (i) K1.1 mRNA, an LNP encapsulated mRNA targeted for liver cancer, and (ii) SBFM-PL4, a protease
inhibitor for treatment of SARS Coronavirus infections.
Commercial Operations
Our commercial operations are focused on the procurement
of rights to pharmaceutical products for sale, currently in Canada and ultimately around the world. We seek to secure such rights through
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. 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.
·
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 label.
Read full description ↓
·
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 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 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.
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We currently have the following generic prescription
drugs on the market in Canada:
Drug
Therapeutic Area
Brand
Abiraterone*
Oncology
Zytiga®
Alendronate
Osteoporosis
Fosamax®
Amlodipine
Cardiovascular
Norvasc®
Apixaban
Cardiovascular
Eliquis®
Aripiprazole
Antipsychotic
Abilify®
Atorvastatin
Cardiovascular
Lipitor®
Azithromycin
Antibacterial
Zithromax®
Betahistine
Vertigo
Serc®
Bilastine
Allergy
Blexten®
Candesartan
Hypertension
Atacand®
Candesartan HCTZ
Hypertension
Atacand Plus®
Celecoxib
Anti-inflammatory
Celebrex®
Cetirizine
Allergy
Reactine®
Ciprofloxacin
Antibiotic
Cipro®
Citalopram
Central nervous system
Celexa®
Clindamycin
Antibiotic
Dalacin®
Clobetasol*
Anti-inflammatory
Clobex®
Clopidogrel
Cardiovascular
Plavix®
Dapagliflozin
Diabetes
Forxiga®
Daptomycin*
Antibacterial
Cubicin®
Dasatinib*
Oncology
Sprycel®
Docusate
Gastroenterology
Colace®
Donepezil
Central nervous system
Aricept®
Doxycycline
Antibacterial
Vibramycin®
Duloxetine
Central nervous system
Cymbalta®
Dutasteride
Urology
Avodart®
Ertapenem*
Antibacterial
Invanz®
Escitalopram
Central nervous system
Cipralex®
Everolimus*
Oncology
Afinitor®
Ezetimibe
Cardiovascular
Ezetrol®
Finasteride
Urology
Proscar®
Fluconazole
Antifungal
Diflucan®
Fluoxetine
Central nervous system
Prozac®
Gabapentin
Central nervous system
Neurontin®
Hanzema®*
Dermatology
Toctino®
Hydroxychloroquine
Antimalarial
Plaquenil®
Letrozole
Oncology
Femara®
Levetiracetam
Central nervous system
Keppra®
Lurasidone
Antipsychotic
Latuda®
Metformin
Diabetes
Glucophage®
Mirtazapine
Central nervous system
Remeron®
Montelukast
Allergy
Singulair®
Olanzapine
Central nervous system
Zyprexa®
Olanzapine ODT
Central nervous system
Zyprexa®
Olmesartan
Cardiovascular
Olmetec®
Olmesartan HCTZ
Cardiovascular
Olmetec Plus®
Pantoprazole
Gastroenterology
Pantoloc®
Paroxetine
Central nervous system
Paxil®
Pegfilgrastim
Oncology
Neulasta®
Perindopril
Cardiovascular
Coversyl®
Pravastatin
Cardiovascular
Pravachol®
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Pregabalin
Central nervous system
Lyrica®
Progesterone*
Women's Health
Prometrium®
Prucalopride
Women's Health
Resotran®
Quetiapine
Central nervous system
Seroquel®
Quetiapine XR
Central nervous system
Seroquel XR®
Ramipril
Cardiovascular
Altace®
Rivaroxaban*
Cardiovascular
Xarelto®
Rizatriptan ODT
Central nervous system
Maxalt® ODT
Rosuvastatin
Cardiovascular
Crestor®
Sertraline
Central nervous system
Zoloft®
Sildenafil
Urology
Viagra®
Tadalafil
Urology
Cialis®
Telmisartan
Cardiovascular
Micardis®
Telmisartan HCTZ
Cardiovascular
Micardis Plus®
Topiramate
Anticonvulsant
Topamax®
Ursodiol
Cholelithiasis
Urso®
Varenicline
Smoking cessation
Champix®
Zoledronic Acid*
Osteoporosis
Aclasta®
Zolmitriptan
Central nervous system
Zomig®
Zopiclone
Central nervous
system
Imovane®
*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
The following table summarizes our proprietary
drugs in development:
Drug Candidate
Therapeutic Area/Indication
Development Stage
K1.1 (mRNA LNP)
Oncology (Liver Cancer)
Animal Testing
SBFM-PL4
(Small Molecule)
Antiviral
(SARS Coronavirus)
Animal
Testing
K1.1 Anticancer mRNA
In June 2021, we initiated a new research project
in which we set out to determine if certain mRNA molecules can be used as anti-cancer agents. The data collected to date have shown that
a selected group of mRNA molecules are capable of destroying cancer cells in vitro including multidrug resistant breast cancer cells (MCF-7/MDR),
ovarian adenocarcinoma cells (OVCAR-3), and pancreatic cancer cells (SUIT-2). Studies using non-transformed (normal) human cells (HMEC
cells) showed that these mRNA molecules had little cytotoxic side effects. These new mRNA molecules, bearing the laboratory name K1.1,
were adapted for delivery into patients using a lipid nanoparticle (LNP) technology similar to the one employed in the COVID-19 mRNA vaccines.
On April 20, 2022, we filed a provisional patent application in the United States covering our K1.1 mRNA molecules.
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In November 2022, we concluded an agreement with
a specialized commercial partner for the purposes of formulating our K1.1 mRNA molecules into specific lipid nanoparticles for use in
test animals including xenograft mice. The initial results of our animal testing indicated that our K1.1 mRNA-LNP constructs were effective
at reducing the size of liver cancer tumors in xenograft mice. We are currently seeking to confirm these results by conducting additional
xenograft experiments on a broader scale and in more detailed dose-response studies.
SBFM-PL4 SARS Coronavirus Treatment
The initial genome expression products following
infection by Betacoronavirus, the causative agent of COVID-19, are two large polyproteins, referred to as pp1a and pp1ab. These two polyproteins
are cleaved at 15 specific sites by two virus encoded proteases, called Mpro and PLpro, to generate 16 different non-structural proteins
essential for viral replication. Mpro and PLpro represent attractive anti-viral drug development targets as they play a central role in
the early stages of viral replication. PLpro is of particular interest as a therapeutic target in that, in addition to processing essential
viral proteins, it is also responsible for suppression of the human immune system making the virus more life-threatening. PLpro is present
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 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
research effort by entering into a research agreement with the University of Arizona for the purposes of conducting research focused on
determining the in vivo safety, pharmacokinetics, and dose selection properties of three University of Arizona owned PLpro inhibitors,
to be followed by efficacy testing in mice infected with SARS-CoV-2 (the “Research Project”). Under the agreement, the University
of Arizona granted us a first option to negotiate a commercial, royalty-bearing license for all intellectual property developed by University
of Arizona under the Research Project. In addition, we and the University of Arizona have entered into an option agreement (the “Option
Agreement”) whereby we were granted a first option to negotiate a royalty-bearing commercial license for the underlying technology
of the Research Project. On September 13, 2022, we exercised our options, and on February 24, 2023, we entered into an exclusive worldwide
license agreement with the University of Arizona for all of the technology related to the Research Project.
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. Med. Chem. 2024, 67, 13681−13702). A copy of this article is available on our
website at: 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.
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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, 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 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
application in the United States covering mRNA molecules capable of destroying cancer cells in vitro. The patent application contains
composition and utility subject matter pertaining to the structure and sequence of the relevant mRNA molecules.
Effective February 24, 2023, we became the exclusive,
worldwide licensee of the University of Arizona for three (3) patents related to small molecules which inhibit the Coronavirus protease,
PLpro.
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
by Health Canada including (i) NPN 80089663 which authorizes us to manufacture and sell our in-house developed OTC product, Essential•9™,
(ii) NPN 80093432 which authorizes us to manufacture and sell the OTC product, Calcium-Vitamin D, (iii) NPN 80125047 which authorizes
us to manufacture and sell the OTC product, L-Citrulline, and (iv) NPN 80127436 which authorizes us to manufacture and sell the OTC product,
Taurine.
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.”
and Design.
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
All of our business operations, including our generic
drugs, proprietary drugs, and OTC products operations, are subject to extensive and frequently changing federal, state, provincial and
local laws and regulations.
In the United States, the Federal Government agency
responsible for regulating prescription drugs and nonprescription OTC supplements is the U.S. Food and Drug Administration (“FDA”).
The Canadian counterpart to the FDA is Health Canada. Though the FDA and Health Canada have generally similar requirements for drugs and
OTC supplements to be approved or allowed to be marketed, approval in one jurisdiction does not automatically result in approval in the
other. In Canada, prescription drugs and nonprescription OTC supplements are authorized through the issuance by Health Canada of a Drug
Identification Number (DIN) for the former and a Natural Product Number (NPN) for the latter. In the United States, OTC supplements are
required to be registered with the FDA prior to marketing. In both the U.S. and Canada, the ingredients, manufacturing processes and facilities
for all drugs and OTC supplements must meet the guidelines for Good Manufacturing Practices (“GMP”). Moreover, all drug manufacturers
must perform a series of tests, both during and after production, to show that every drug or supplement batch made meets the regulatory
requirements for that product.
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Our generic prescription medicines are produced
in compliance with GMP guidelines as for brand-name drugs. Prescription drugs dossiers are filed with Health Canada in order to obtain
a manufacturing Notice of Compliance (NOC) and a Drug Identification Number (DIN). The same grant the applicant marketing authorization
in Canada. 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. in order to
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
trials. Following 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.
In respect of OTC supplements, the FDA regulates
the formulation, manufacturing, packaging, storage, labeling, promotion, distribution, and sale of such products, while the Federal Trade
Commission (“FTC”) regulates marketing and advertising claims. In August 2007, a rule issued by the FDA went into effect requiring
companies that manufacture, package, label, distribute or hold OTC supplements to meet certain GMP requirements to ensure such products
are of the quality specified and are properly packaged and labeled. We are committed to meeting or exceeding the standards set by the
FDA and the FTC and we believe we are currently operating within both the FDA and FTC mandates.
Manufacturing
Our generic drugs are manufactured by our various
international partners (licensors or distribution partners) under long-term contracts. We purchase finished goods from these partners
at varying costs. 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
Our
generic drugs are currently being sold in Canada in the province of Quebec, and to a much lesser extent in the provinces of Ontario,
Alberta and British Columbia. All of our generic drug sales are conducted by Nora Pharma’s sales representatives. A segment of
our marketing team provides human resources, commercial and technical assistance, as well as training and educational support to pharmacy
owners. We believe these pharmacy support activities, which we provide mostly free of charge, enhance our visibility in the marketplace
and bolster our sales efforts.
Our
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.
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Competition
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. 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.
Our Anti-Coronavirus drug development project is
in direct competition with several companies in the U.S. that have developed effective vaccines or treatment options for COVID-19. The
companies focused on treatments include Pfizer, Merck, Gilead, Eli Lilly, and Regeneron. Today two leading vaccines (Pfizer’s, and
Moderna’s) and two antibody treatments (Regeneron’s, and Eli Lilly’s) are in use. Gilead’s Remdesivir, an antiviral
injectable, was approved by the FDA for treatment of COVID-19 in October 2020. In addition, in December 2021, Pfizer received Emergency
Use Authorization (“EUA”), for its antiviral pill, Paxlovid, and, in the same month, the FDA granted Merck EUA for its antiviral
pill, Molnupiravir. While the approved vaccines, pills and injectable treatments are effective, we believe that additional treatment options
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 physicians.
In the area of anticancer drug development, we
compete with large publicly and privately held companies engaged in developing new cancer therapies. There are numerous other entities
engaged in oncology therapeutics development that have greater resources than us. Nearly all major
pharmaceutical companies including Merck, Amgen, Roche, Pfizer, Bristol-Myers Squibb and Novartis, to name a few, have on-going anticancer
drug development programs and some of the drugs they may develop could be in direct competition with our own. In addition, a number of
smaller companies are working in the area of cancer therapy and could develop drugs that may be in competition with ours.
Similarly, our OTC products compete within a very
crowded and highly competitive product sector. As of the date of this report, we believe Essential•9™ is the only Essential
Amino Acid supplement that comprises all 9 essential amino acids in capsule form.
Workforce
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. These laws
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.
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