Bionxt Solutions receives Eurasian patent grant

Executive Summary

• Bionxt Solutions Inc. has secured a final patent grant from the Eurasian Patent Organization (EAPO) for its sublingual cladribine platform, specifically covering the delivery of anti-cancer drugs for autoimmune and neurodegenerative diseases.
• The patent (No. 051510) provides intellectual property protection across all eight EAPO member states, representing a combined population of over 200 million people, and is valid until June 14, 2043.
• This milestone supports the company's global IP strategy and commercialization efforts, coinciding with ongoing preclinical studies, including a large-mass animal bioequivalence study and planned human bioequivalence studies.

Key Details

• Patent Specifics: Eurasian Patent Organization Patent No. 051510, issued on November 14, 2025.
• Scope of Protection: Covers sublingual delivery of anti-cancer drugs for autoimmune and neurodegenerative diseases, including lead product candidate BNT23001 (sublingual thin-film formulation of cladribine for multiple sclerosis).
• Geographic Coverage: Valid in all eight EAPO member states: Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, and Turkmenistan.
• Market Reach: The covered regions represent a combined population of more than 200 million people.
• Validity Period: The patent is valid through June 14, 2043.
• Strategic Context: Identified as Bionxt's first national-level patent grant.
• Upcoming Catalysts: CEO Hugh Rogers cites the ongoing two-week large-mass animal bioequivalence study, expected results from this study, the launch of a human bioequivalence study, and additional national patent grants as key upcoming milestones.
• Global IP Expansion:
  • European Union: European Patent Office (EPO) has issued an intention to grant, confirming novelty, inventive step, and industrial applicability.
  • United States: Track 1 priority filing is currently underway.
  • Other Markets: Parallel nationalization efforts are progressing in Canada, Australia, New Zealand, and Japan.

Notable Quotes

• "The Eurasian patent grant marks a major milestone in our value creation and commercialization strategy... This is Bionxt's first national-level patent and it arrives at a pivotal time, with our two-week large-mass animal bioequivalence study currently under way. We expect meaningful catalysts in the coming weeks and months, including additional national patent grants, results from the animal study, and the launch of our human bioequivalence study. We are confident that these milestones will accelerate ongoing discussions with potential regional and global licencing partners." — Hugh Rogers, Chief Executive Officer