BioNxt Solutions Inc. announced today that the Eurasian Patent Organization (EAPO) has accepted the company's first national-level patent filing, confirming its core claims of novelty, inventive step, and industrial applicability. This milestone represents a significant advancement for the bioscience innovator's drug delivery technology platform.
The patent filing covers BioNxt's sublingual delivery system for anticancer drugs in the treatment of autoimmune neurodegenerative diseases. This technology forms the foundation for the company's lead product, BNT23001, a sublingual thin-film formulation of Cladribine specifically developed for multiple sclerosis (MS) treatment.
"This patent acceptance by the EAPO validates our innovative approach to drug delivery systems," said Hugh Rogers, Co-Founder, CEO and Director of BioNxt. "It represents a critical step in our commercialization strategy for our sublingual platform technology."
Strategic Patent Protection Across Multiple Regions
The EAPO approval grants patent protection across eight member states: Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, and Turkmenistan. These countries are part of the Eurasian Patent Convention (EAPC), which provides a harmonized patent application process for the region.
This development follows a positive international examination report from the European Patent Office received in September 2024. BioNxt is simultaneously advancing the nationalization phase of patent protection with the European Patent Office and independent filing nations including Australia, Canada, New Zealand, USA, and Japan.
Innovative Drug Delivery Platform for Autoimmune Diseases
BioNxt's patent family creates numerous proprietary product development and commercialization opportunities beyond its lead MS treatment. The company's pipeline includes sublingual products targeting other autoimmune conditions such as myasthenia gravis (MG), lupus nephritis (LN), and rheumatoid arthritis (RA).
The sublingual thin-film technology offers potential advantages over conventional drug delivery methods, including improved bioavailability, more convenient administration, and potentially reduced side effects compared to traditional oral or injectable formulations.
Cladribine for MS: A Novel Delivery Approach
Cladribine, the active pharmaceutical ingredient in BioNxt's lead product BNT23001, is already approved for MS treatment in conventional formulations. However, BioNxt's sublingual thin-film approach represents a novel delivery method that could potentially improve patient experience and treatment outcomes.
Multiple sclerosis affects approximately 2.8 million people worldwide, with a significant unmet need for more convenient and effective treatment options. The global MS therapeutics market is projected to reach $33 billion by 2029, highlighting the commercial potential for innovative delivery systems like BioNxt's technology.
Comprehensive Drug Delivery Portfolio
Beyond its sublingual platform, BioNxt is developing additional proprietary drug delivery technologies including transdermal (skin patch) and oral (enteric-coated tablets) systems. These platforms target key therapeutic areas including autoimmune diseases, neurological disorders, and longevity-related conditions.
With research and development operations in both North America and Europe, the company is primarily focused on European markets for its initial commercialization efforts. BioNxt is listed on the Canadian Securities Exchange (BNXT), OTC Markets (BNXTF), and trades in Germany under WKN: A3D1K3.
The patent approval represents a significant milestone in BioNxt's intellectual property strategy, providing the foundation for future commercial opportunities and potential partnerships in the pharmaceutical industry.
