BioNxt Secures Final Patent Grant from the Eurasian Patent Organization for Sublingual Cladribine Platform
Rhea-AI Summary
BioNxt (OTCQB:BNXTF) announced that the Eurasian Patent Organization granted Patent No. 051510 (issued November 14, 2025) covering sublingual delivery of anticancer drugs, including BioNxt's lead candidate BNT23001, a sublingual cladribine thin-film for multiple sclerosis. The patent provides protection across all eight EAPO member states—Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, and Turkmenistan—covering a combined population of more than 200 million, and is valid through June 14, 2043.
BioNxt said an ongoing two-week large-mass animal bioequivalence study is underway and a human bioequivalence study is planned. The company noted an EPO Intention to Grant and ongoing Track One U.S. priority filing plus nationalization efforts in Canada, Australia, New Zealand, and Japan as part of its global IP and commercialization strategy.
Positive
- EAPO patent granted (No. 051510) issued November 14, 2025
- Patent protection across 8 EAPO states covering >200 million people
- Patent term valid through June 14, 2043
- EPO issued an Intention to Grant confirming novelty and inventive step
- Two-week large-mass animal bioequivalence study currently underway
Negative
- Key value drivers depend on upcoming animal and human study results
- Global protection remains incomplete; nationalization efforts in multiple jurisdictions ongoing
News Market Reaction
On the day this news was published, BNXTF gained 9.60%, reflecting a notable positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
VANCOUVER, BC / ACCESS Newswire / November 20, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT), a bioscience innovator specializing in advanced drug delivery systems, is pleased to announce that the Eurasian Patent Organization (EAPO) has officially granted Patent No. 051510 (issued November 14, 2025).
The patent covers the sublingual delivery of anticancer drugs for the treatment of autoimmune and neurodegenerative diseases, including BioNxt's lead product candidate BNT23001, a sublingual thin-film formulation of cladribine for multiple sclerosis (MS). The patent grant provides protection across all eight EAPO member states (Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, and Turkmenistan) representing a combined population of more than 200 million people. The patent is valid through June 14, 2043.
A Key Milestone for BioNxt's Global IP Strategy
"The Eurasian patent grant marks a major milestone in our value creation and commercialization strategy," said Hugh Rogers, CEO of BioNxt. "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 underway. 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."
Expanding Global Patent Coverage
BioNxt continues to advance patent nationalization across key global pharmaceutical markets, including the European Union, where the European Patent Office (EPO) has issued an Intention to Grant and confirmed novelty, inventive step, and industrial applicability. In the United States, a Track One priority filing is underway, while parallel nationalization efforts progress in Canada, Australia, New Zealand, and Japan. Together, these regions represent some of the world's largest and most advanced pharmaceutical markets and form the foundation for BioNxt's commercialization and partnering initiatives.
About BioNxt Solutions Inc.
BioNxt Solutions Inc. is a bioscience innovator focused on next-generation drug delivery technologies, diagnostic screening systems, and active pharmaceutical ingredient development. The Company's proprietary platforms-Sublingual (Thin-Film), Transdermal (Skin Patch), and Oral (Enteric-Coated Tablets)-target key therapeutic areas, including autoimmune diseases, neurological disorders, and longevity.
With research and development operations in North America and Europe, BioNxt is advancing regulatory approvals and commercialization efforts, primarily focused on European markets. BioNxt is committed to improving healthcare by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide.
BioNxt is listed on the Canadian Securities Exchange: BNXT, OTC Markets: BNXTF and trades in Germany under WKN: A3D1K3. To learn more about BioNxt, please visit www.bionxt.com.
Investor Relations & Media Contact
Hugh Rogers, Co-Founder, CEO and Director
Email: investor.relations@bionxt.com
Phone: +1 778.598.2698
Web: www.bionxt.com
LinkedIn: https://www.linkedin.com/company/bionxt-solutions
Instagram: https://www.instagram.com/bionxt
Cautionary Statement Regarding "Forward-Looking" Information
This press release contains forward-looking statements within the meaning of applicable securities laws, including statements regarding the development, testing, regulatory approval, and commercialization of BioNxt's sublingual drug products, as well as projected milestones, anticipated partnerships, and potential market opportunities. Forward-looking statements are inherently subject to significant risks, uncertainties, and assumptions, many of which are beyond BioNxt's control. Factors that could cause actual results to differ materially include, but are not limited to, delays in regulatory approvals, negative outcomes from clinical trials, changes in market demand, fluctuations in funding availability, or disruptions in supply chains. Readers are cautioned not to place undue reliance on these forward-looking statements, as actual results may differ materially from those expressed or implied. BioNxt undertakes no obligation to update or revise forward-looking statements, except as required by law. Factors that could cause actual results to differ materially from those projected include changes in market demand, regulatory developments, delays in clinical trials, fluctuations in financing availability, supply chain disruptions, and unforeseen competitive pressures.
SOURCE: BioNxt Solutions Inc.
View the original press release on ACCESS Newswire
FAQ
What did BioNxt announce about the EAPO patent for BNT23001 (BNXTF) on November 20, 2025?
Which countries does the EAPO patent for BioNxt (BNXTF) cover and how many people are affected?
What clinical milestones did BioNxt (BNXTF) report alongside the EAPO patent grant?
Has BioNxt (BNXTF) secured patent protection outside the EAPO region?
How long is BioNxt's EAPO patent valid and when was it issued?
