BioNxt Secures Final Patent Grant from the Eurasian Patent Organization for Sublingual Cladribine Platform

Executive Summary

• The Eurasian Patent Organization granted BioNxt Solutions Inc. Patent No. 051510 covering sublingual delivery of anticancer drugs across eight member states, protecting a population of over 200 million.
• The patent protects the company’s lead candidate BNT23001 (sublingual thin‑film cladribine for multiple sclerosis) through June 14 2043.
• BioNxt highlighted this grant as a key milestone in its global IP strategy and noted ongoing animal bioequivalence studies, upcoming human studies, and continued patent nationalization efforts in the EU, U.S., Canada, Australia, New Zealand, and Japan.

Key Details

• Patent Grant: Eurasian Patent Organization issued Patent No. 051510 on 14 Nov 2025; protection extends to Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, Turkmenistan.
• Scope & Duration: Covers sublingual delivery of anticancer drugs for autoimmune and neurodegenerative indications; valid until 14 Jun 2043.
• Lead Product Covered: BNT23001 – a sublingual thin‑film formulation of cladribine targeting multiple sclerosis.
• Population Impact: Combined population of the eight EAPO member states exceeds 200 million people.
• CEO Statement: Hugh Rogers called the grant “a major milestone” for value creation and commercialization, linking it to ongoing large‑mass animal bioequivalence studies and upcoming human studies.
• Future IP Milestones:
• European Patent Office has issued an Intention to Grant with confirmed novelty, inventive step, and industrial applicability.
• Track One priority filing underway in the United States.
• Parallel nationalization efforts progressing in Canada, Australia, New Zealand, and Japan.
• Strategic Implications: Expanded IP portfolio expected to accelerate licensing discussions with regional and global partners.

Notable Quotes

“The Eurasian patent grant marks a major milestone in our value creation and commercialization strategy,” – Hugh Rogers, CEO, BioNxt Solutions Inc.

Materiality Assessment: Non‑Material – Positive (the announcement is materially positive for the company’s IP position but does not contain immediate financial impact).