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BioNxt Solutions Inc. reports developments in bioscience and advanced drug delivery systems, with recurring updates on sublingual oral thin films, transdermal skin patches, oral enteric-coated tablets, diagnostic screening systems and active pharmaceutical ingredient development. Its lead program, BNT23001, is a proprietary sublingual cladribine oral thin film designed for relapsing forms of multiple sclerosis and other autoimmune neurodegenerative diseases.
Company news also covers patent protection for its oral thin-film technology, GMP manufacturing of clinical-grade cladribine film through a European CDMO, semaglutide as an initial GLP-1 oral thin-film application, commercialization planning, and capital-structure actions such as shares issued to settle debt.
BioNxt Solutions (OTC:BNXTF) has reached a significant milestone in its multiple sclerosis (MS) drug development program with the receipt of the active pharmaceutical ingredient (API) for BNT23001, their proprietary sublingual thin-film formulation of cladribine.
The company will now proceed with clinical batch manufacturing through their European partner, Gen-Plus GmbH & Co KG, in preparation for a human bioequivalence study planned for H2 2025. BNT23001 is designed as an alternative to traditional oral cladribine tablets like Mavenclad®, offering a rapidly dissolving sublingual film particularly beneficial for MS patients with swallowing difficulties.
Preclinical studies have shown promising results with high absorption rates and bioequivalence to existing oral therapies, without toxic effects. The company is also advancing patent applications in key markets including Europe, the US, and Canada.
BioNxt Solutions (OTC:BNXTF) announced that the British Columbia Securities Commission has revoked the temporary management cease trade order (MCTO) that was previously issued on May 1, 2025. The revocation comes after the company successfully filed its required annual financial documents for the year ended December 31, 2024.
The completion of these filings means that company management can now resume trading BioNxt securities. All annual filings are now accessible through the company's SEDAR+ profile.
BioNxt Solutions (BNXTF) has received formal notice from the European Patent Office (EPO) of their intention to grant the company's core patent for sublingual delivery of anticancer drugs treating autoimmune neurodegenerative diseases. The patent is particularly significant for BNT23001, their lead product - a sublingual thin-film formulation of Cladribine designed to treat multiple sclerosis (MS).
The company is advancing patent protection through the EPO, Eurasian Patent Organization, and independent nations including Australia, Canada, New Zealand, USA, and Japan. This intellectual property will support BioNxt's pipeline of sublingual products targeting various autoimmune diseases including MS, myasthenia gravis, lupus nephritis, and rheumatoid arthritis.
BioNxt Solutions (BNXTF) has announced the consolidation of its research, development, and commercialization activities at the Gen-Plus CRDO facility in Munich, Germany. The integration provides access to a 1,000-square-meter state-of-the-art laboratory space equipped for high-potency pharmaceutical development and GMP-compliant processes.
The company will leverage Gen-Plus's advanced infrastructure to enhance its drug delivery systems, focusing on their lead product BNT23001, a sublingual thin-film formulation of Cladribine for multiple sclerosis treatment. Immediate plans include preparation for human bioequivalence studies, including placebo trials, product transfer, manufacturing upscaling, and analytical validation.
BioNxt Solutions (BNXTF) has received acceptance of its first national level patent filing from the Eurasian Patent Organization (EAPO). The patent, which previously received a positive international examination report from the European Patent Office in September 2024, covers sublingual delivery of anticancer drugs for treating autoimmune neurodegenerative diseases.
The patent notably includes BioNxt's lead product, BNT23001, a sublingual thin-film formulation of Cladribine for multiple sclerosis treatment. The EAPO protection extends across eight member states: Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, and Turkmenistan. The company is also pursuing patent protection in Australia, Canada, New Zealand, USA, and Japan to support commercialization opportunities for its pipeline of sublingual products targeting various autoimmune diseases.