Sunshine Biopharma Advances Lead Coronavirus Drug Candidate into IND-Enabling Studies

Sunshine Biopharma moves a preclinical PLpro coronavirus inhibitor into IND-enabling studies after reporting strong potency, exposure and in vivo antiviral effects.

Rhea-AI Summary

Sunshine Biopharma (SBFM) has advanced its lead coronavirus PLpro inhibitor into IND-enabling studies, following preclinical work disclosed through 2026 publications.

The nominated small-molecule candidate showed nanomolar potency against the viral protease and broad-spectrum in vitro activity across SARS-CoV-2 variants of concern. It demonstrated favorable ADME characteristics, with high oral bioavailability in mice, rats and dogs, and preferential lung enrichment in mice and rats. In K18-hACE2 mice infected with human SARS-CoV-2, repeated oral dosing produced significant, dose-dependent suppression of pulmonary viral replication. Sunshine Biopharma describes this as a differentiated antiviral program with both scientific and commercial potential within its broader pipeline.

Positive

• Lead PLpro inhibitor advanced into IND-enabling studies
• Nanomolar potency against viral protease with broad SARS-CoV-2 variant activity in vitro
• High oral bioavailability reported in mice, rats and dogs
• Preferential lung enrichment observed in mice and rats
• Dose-dependent suppression of pulmonary viral replication in infected K18-hACE2 mice

Negative

• None.

Market Context

At $1.03 pre-headline, SBFM had declined 3.74% from the prior daily close; no peers appeared in the ...

Analysis

At $1.03 pre-headline, SBFM had declined 3.74% from the prior daily close; no peers appeared in the momentum scanner, providing a pre-publication baseline rather than a news reaction.

Key Figures

PLpro potency: Nanomolar

PLpro potency

Nanomolar

Lead coronavirus drug candidate; in vitro

Key Terms

plpro, adme, ind-enabling studies

3 terms

plpro technical

"Nanomolar potency against PLpro with broad-spectrum SARS-CoV-2 variants activity"

PLpro is an enzyme produced by certain viruses that acts like a pair of scissors to cut viral proteins into working pieces and also helps the virus hide from the body’s defenses. For investors, PLpro matters because drugs or tests that block or measure this enzyme can stop virus replication or improve treatments, so developments involving PLpro can affect the value and prospects of biotech companies developing antivirals.

adme medical

"It exhibited desirable ADME profiles and was assessed in a general mammalian toxicology study"

ADME stands for Absorption, Distribution, Metabolism and Excretion — the four processes that determine how a drug enters the body, moves to target tissues, is chemically changed, and is removed. For investors, ADME profiles signal whether a drug is likely to be effective, safe and practical to dose; weak ADME can sink a program just like delivery problems can ruin a product launch, while strong ADME improves chances of regulatory approval and commercial success.

ind-enabling studies regulatory

"advanced its lead Coronavirus drug candidate into IND-enabling studies"

Ind-enabling studies are early research efforts that test whether a new drug or treatment is safe and effective enough to move forward in development. They are like preliminary tests to ensure a product works as intended before investing more resources into large-scale trials. For investors, these studies are important because successful results can signal potential progress toward bringing a new product to market, impacting its future value.

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• Nanomolar potency against PLpro with broad-spectrum SARS-CoV-2 variants activity
• Significant dose-dependent suppression of pulmonary viral replication in vivo
• Strong oral bioavailability and preferential lung enrichment across multiple species

FORT LAUDERDALE, FL / ACCESS Newswire / September 16, 2026 / Sunshine Biopharma Inc. (NASDAQ:SBFM) (the "Company"), a leading pharmaceutical company specializing in generic and specialty prescription medications including drugs in oncology and antivirals, is pleased to announce that it has advanced its lead Coronavirus drug candidate into IND-enabling studies. The Company had previously published laboratory results on its library of Anti-Coronavirus compounds in August 2024 (J. Med. Chem. 2024, 67, 13681−13702) and more recently in March 2026 (J. Med. Chem. 2026, 69, 8433−8450). Copies of these two publications are available on the Company website at www.sunshinebiopharma.com.

The drug candidate we have nominated for advanced development displayed nanomolar potency against the viral protease and had broad-spectrum activity against other SARS-CoV-2 variants of concerns in vitro. It exhibited desirable ADME profiles and was assessed in a general mammalian toxicology study in rats. Our drug candidate had high oral bioavailability in mice, rats and dogs. In Addition, it was preferentially enriched in the lungs of both mice and rats. In the K18-hACE2 mice infected with human SARS-CoV-2 virus, repeated oral administrations of the drug candidate significantly suppressed pulmonary viral replication in a dose-dependent manner.

"Advancing our potent PLpro inhibitor is a strategically significant development for Sunshine Biopharma and a clear validation of the discovery infrastructure we've built. The compound's profile - potent inhibition across SARS-CoV-2 variants, strong oral bioavailability in multiple species, preferential lung enrichment, and dose dependent viral suppression in the K18 hACE2 model - places us in a highly competitive position as we move toward IND enabling studies. These are not incremental data points; they represent a differentiated antiviral candidate with real potential to shape the next generation of coronavirus therapeutics," said Dr. Steve Slilaty, CEO of Sunshine Biopharma.

"We are executing with precision and urgency. Our focus is on accelerating development while maintaining the discipline required in the drugs regulatory environment. With this nomination, Sunshine Biopharma is advancing a program with both scientific depth and commercial relevance, and we intend to capitalize on the momentum this milestone creates," he added.

About Sunshine Biopharma Inc.

Sunshine Biopharma currently has 60 generic prescription drugs on the market in Canada and approximately 12 additional drugs scheduled to be launched in the remainder of 2026. In addition, Sunshine Biopharma is conducting a proprietary drug development program which is comprised of (i) K1.1 mRNA, an mRNA-Lipid Nanoparticle targeted for liver cancer, and (ii) PLpro protease inhibitor, a small molecule for treatment of SARS Coronavirus infections. For more information, please visit: www.sunshinebiopharma.com.

Safe Harbor Forward-Looking Statements

This press release contains forward-looking statements which are based on current expectations, forecasts, and assumptions of Sunshine Biopharma Inc. (the "Company") that involve risks as well as uncertainties that could cause actual outcomes and results to differ materially from those anticipated or expected. These statements appear in this release and include all statements that are not statements of historical fact regarding the intent, belief or current expectations of the Company, including statements related to the Company's drug development activities, financial performance, and future growth. These risks and uncertainties are further described in filings and reports by the Company with the U.S. Securities and Exchange Commission (SEC). Actual results and the timing of certain events could differ materially from those projected in or contemplated by the forward-looking statements due to a number of factors detailed from time to time in the Company's filings with the SEC. Reference is hereby made to cautionary statements and risk factors set forth in the Company's most recent SEC filings.

For more information, please contact:

Camille Sebaaly, CFO
Direct Line: 514-814-0464
camille.sebaaly@sunshinebiopharma.com

SOURCE: Sunshine Biopharma Inc.

View the original press release on ACCESS Newswire

FAQ

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What specific preclinical efficacy was observed for the coronavirus candidate in vivo?

In K18-hACE2 mice infected with human SARS-CoV-2, repeated oral administrations of the drug candidate significantly suppressed pulmonary viral replication in a dose-dependent manner.

What pharmacokinetic and distribution characteristics did the candidate show?

The drug candidate exhibited desirable ADME profiles, with high oral bioavailability in mice, rats and dogs, and was preferentially enriched in the lungs of both mice and rats.

Where can investors access the detailed scientific data on Sunshine Biopharma's anti-coronavirus compounds?

Laboratory results were published in the Journal of Medicinal Chemistry in August 2024 (vol. 67, pp. 13681−13702) and March 2026 (vol. 69, pp. 8433−8450). Copies of these publications are available on the company website at www.sunshinebiopharma.com.

What other programs are in Sunshine Biopharma's proprietary development pipeline?

The proprietary program includes (i) K1.1 mRNA, an mRNA-lipid nanoparticle targeted for liver cancer, and (ii) a PLpro protease inhibitor for treatment of SARS coronavirus infections.

What commercial products does Sunshine Biopharma currently market?

Sunshine Biopharma has 60 generic prescription drugs on the market in Canada and approximately 12 additional drugs scheduled to be launched during the remainder of 2026.