Original News Release
Bionxt's European patent applications accepted
Mr. Hugh Rogers reports
BIONXT SOLUTIONS REPORTS PENDING PATENT GRANTS IN EUROPE AND EURASIA, STRENGTHENING IP PROTECTION FOR PROPRIETARY SUBLINGUAL CLADRIBINE-BASED MS TREATMENT
Bionxt Solutions Inc. has made significant progress in its global patent portfolio. The company has received formal communications from both the European Patent Office (EPO) and the Eurasian Patent Organization (EAPO), confirming that the core claims of its patent application covering its proprietary sublingual cladribine thin-film formulation have been accepted, with full grants anticipated in the near future. The patent further covers all applications of chemotherapy drugs in an oral-dissolvable delivery system for the treatment of autoimmune neurological diseases.
Advancing toward formal patent grant
European Patent Office: The EPO has issued an office action with the intention to grant for Bionxt's key patent application. This confirmation signifies that all core claims have met the European requirements for novelty, inventive step and industrial applicability. Only minor formal amendments were requested, which the company has already addressed. The next office action is expected within the coming weeks.
Eurasian Patent Organization: The EAPO, covering eight member countries across Eastern Europe and Central Asia, has issued a formal notice that Bionxt's patent application has likewise been accepted. Minor language modifications were required and have been promptly submitted. The company anticipates a full patent grant across all member states in the near term.
Global patent strategy and expansion
Bionxt previously filed an international patent application under the Patent Cooperation Treaty (PCT) to establish a co-ordinated framework for securing patent protection for its sublingual cladribine thin-film technology and future products in multiple key markets. The company has entered the national phase of this application in major pharmaceutical jurisdictions, including the United States, Canada, Japan, Australia and New Zealand.
These national phase applications are currently progressing through local examination procedures. Patent protection in these regions will support Bionxt's long-term strategy for global commercialization, regulatory alignment and regional partnership development.
Protecting innovation in multiple sclerosis (MS) treatment
The patents under review are designed to protect a family of products, including Bionxt's cladribine-based thin-film formulation, developed for the treatment of relapsing-remitting multiple sclerosis (RRMS). The platform uses sublingual administration to optimize drug absorption, improve patient compliance and avoid first-pass hepatic metabolism, offering a patient-friendly alternative to injectable or conventional oral therapies.
Patent protections include composition of the sublingual film, methods of administration and dosage, use for treating autoimmune diseases, and scalable manufacturing processes.
"Securing intellectual property rights in both Europe and Eurasia marks a critical step forward for our cladribine program and sublingual delivery platform," said Hugh Rogers, chief executive officer of Bionxt Solutions. "These patents represent significant commercial value by protecting a high-potential product, enabling regional exclusivity, and enhancing our ability to generate future licensing and partnership revenue."
Next milestones in patent issuance and product advancement
Bionxt expects formal grant notices and publication from both the EPO and EAPO shortly. In parallel, the company is preparing for GMP (good manufacturing practice) manufacturing and a human bioequivalence clinical study in Europe to support regulatory filings and commercialization. Further updates will be provided as additional national patent offices complete their evaluations.
About Bionxt Solutions Inc.
Bionxt Solutions is a bioscience innovator focused on next-generation drug delivery platforms, diagnostic screening systems and active pharmaceutical ingredient development. Its proprietary platforms include sublingual thin films, transdermal patches, oral tablets and a new targeted chemotherapy platform designed to deliver cancer drugs directly to tumours while reducing side effects.
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 health care by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide.
Bionxt is listed on the Canadian Securities Exchange under the symbol BNXT and on the OTC Markets under the symbol BNXTF and trades in Germany under WKN: A3D1K3.
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