Taiwan's TAH's Antithrombotic Oral Soluble Film Enters Substantive FDA Review, Global Licensing Push Accelerates

TAH (6467-TW) announced that its antithrombotic oral soluble film BEQIA (TAH3311) has officially entered the substantive review stage of the U.S. FDA's New Drug Application (NDA) process. The company is simultaneously advancing global market licensing collaborations to accelerate the product's commercialization.

TAH stated that it resubmitted the NDA for the new formulation of BEQIA to the U.S. FDA on June 19, 2026 (U.S. time). However, since June 19 was a U.S. federal holiday, the official FDA receipt date was June 22. According to a notification from the FDA dated July 14, if no 'incomplete application' notice is received within 60 days of submission, substantive review will begin around August 21. As of August 21, the company had not received such a notice, confirming that BEQIA has formally entered the substantive review phase.

TAH explained that BEQIA is an apixaban-based antithrombotic oral soluble film developed using the TDS (Transdermal/Transmucosal Drug Delivery System) platform technology. The original apixaban drug, marketed as Eliquis, was co-developed by Bristol Myers Squibb (BMS) and Pfizer and is the world's largest small-molecule drug, with over 70% of its use in atrial fibrillation patients to prevent thrombosis. TAH emphasized that BEQIA is specifically designed to meet the medication needs of elderly and dysphagia patients.

TAH also noted that BEQIA has already attracted dozens of pharmaceutical companies across Europe, the Americas, New Zealand, Australia, Latin America, and Asia, all of which have signed confidentiality agreements and are now in substantive licensing discussions.