Full Press Release Details
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.
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 .
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.