Bionxt Solutions, a Canadian life sciences company, has achieved a significant regulatory milestone with the Eurasian Patent Organization (EAPO) granting approval for a core patent covering sublingual drug delivery. This development represents substantial progress toward the company’s objective of treating Multiple Sclerosis using an innovative thin-film medication format.
Strategic Intellectual Property Expansion
The patent notification received Thursday confirms that Bionxt’s application for sublingual administration of cancer medications targeting autoimmune and neurodegenerative conditions has met all necessary requirements. Following payment of publication fees scheduled for this week, formal patent protection will extend across eight member states with a combined population exceeding 200 million.
Patent coverage now encompasses Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, and Turkmenistan. Concurrently, the company has received encouraging feedback from the European Patent Office and is pursuing an accelerated examination process in the United States.
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Clinical Development Progresses Alongside Patent Protection
As its intellectual property portfolio strengthens, Bionxt continues advancing its lead candidate BNT23001. This thin-film formulation is designed to administer Cladribine—an established Multiple Sclerosis therapeutic—via sublingual delivery. The company initiated a 15-day bioequivalence study in larger animals on October 21, with results anticipated in December.
This final preclinical investigation aims to establish dosing parameters for a pivotal human bioequivalence clinical trial scheduled to commence in early 2026. The sublingual delivery method offers potential advantages over conventional tablets or injections, including accelerated absorption, improved bioavailability, and enhanced patient convenience.
Upcoming Catalysts for Investors
Market participants are monitoring Bionxt’s ability to maintain its development timeline, with several near-term events potentially providing clarity on the company’s strategic direction. The December study results, combined with an annual general meeting scheduled for November 7, represent significant milestones that could influence the development pathway forward.
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