On the 16th, TAHO Pharmaceuticals, a biotech company listed on the Emerging Stock Board, announced that all participants in the U.S. Phase III clinical trial for its anti-thrombotic oral dissolving film (ODF) drug, TAH3311, have completed dosing. This marks a significant milestone for the 505(b)(2) regulatory pathway, aimed at bringing a new drug formulation to market. The trial recruited 60 healthy participants and was designed based on U.S. FDA-approved bioequivalence (BE) standards to compare plasma concentrations with the original tablet formulation. Following the completion of the clinical trial data report in the second quarter of 2025, TAHO plans to apply for drug approvals in the U.S. and Europe in the third quarter of 2025 while actively seeking international marketing partners to expand its global market presence.
According to TAHO, TAH3311 is the world’s first Apixaban oral dissolving film (ODF) formulation. It dissolves rapidly in the mouth without requiring water, eliminating the risk of choking and addressing the challenges faced by patients who have difficulty swallowing tablets. Apixaban (brand name Eliquis) is a Factor Xa inhibitor and a first-line treatment for stroke prevention and thromboembolic diseases. Compared to other drugs in its class, it offers advantages such as a lower dosage requirement and reduced risk of gastrointestinal bleeding. Currently, Apixaban is only available in tablet form.
TAHO has utilized proprietary innovative technology to develop the ODF formulation of Apixaban, aiming to better meet clinical needs, particularly for elderly patients, children, stroke patients, and others who suffer from chronic swallowing difficulties. This new formulation provides a more convenient and safer treatment option for these populations.
According to IQVIA data, the market demand for Apixaban continues to grow, with U.S. sales reaching $22.1 billion in 2023, making it the second-highest-selling drug globally after the cancer drug Keytruda. It is also the top-selling small-molecule drug worldwide. TAHO’s development of TAH3311 addresses the clinical limitations of tablet formulations and better meets the needs of special patient groups.
Given that most patent lawsuits between the original manufacturer and generic drug companies have been won by the original manufacturer, with settlements allowing only a few generic manufacturers to begin sales as early as April 2028, TAH3311 has the potential to compete with the original tablet formulation before generic versions enter the market, provided it secures regulatory approval as planned.
Resource: 泰合抗血栓口溶膜新藥 美國臨床三期試驗完成受試者給藥
