Cladribine

BioNxt Solutions has secured a pivotal European patent for its sublingual drug delivery platform, enhancing its intellectual property position for treating autoimmune diseases. The technology underpins BNT23001, a fast-dissolving oral film of Cladribine aimed at revolutionizing multiple sclerosis therapy by replacing injections with a needle-free, bioavailable alternative. Global patent filings are advancing in the U.S., Japan, and Eurasia, targeting a $150B+ autoimmune market. Upcoming bioequivalence studies in 2025 could enable accelerated EU approval. The platform also shows potential for lupus and arthritis treatments, with preclinical data suggesting improved delivery of biologic agents, positioning BioNxt as a leader in precision drug reformulation.