TAHO Pharmaceuticals, a biotech company listed on the emerging stock market, announced on the 8th that its pioneering TAH3311 oral dissolving film for antithrombosis has successfully completed the final report of its pivotal study in the United States. The results of the study met all the required standards. TAHO Pharmaceuticals plans to submit its drug application for the European and U.S. markets by the third quarter of this year, aiming to challenge the position of Apixaban, the world's best-selling small-molecule drug, and compete for a market opportunity worth over $20 billion annually.
TAHO Pharmaceuticals' Chairman, Howard S. Lee, stated that the trial design had been fully discussed with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The trial began in November 2024 and concluded in January 2025, with 60 healthy participants recruited, 48 of whom completed the trial.
The trial results showed that, compared to the original Apixaban tablets (brand name Eliquis) from the U.S. and Europe, TAH3311 met the bioequivalence standards within the legal range of 80-125% for pharmacokinetic indicators, including Cmax (maximum plasma concentration) and AUC (area under the pharmacokinetic curve), under fasting conditions, with a 90% confidence interval (CI) that met the required standards for future drug registration.
Howard S. Lee further explained that TAH3311 is the world's first oral dissolving film formulation of Apixaban for antithrombosis, developed using the unique Transepithelial Delivery System (TDS) for transdermal/mucosal drug delivery. Apixaban is the world's best-selling anticoagulant drug, but its only formulation is in tablet form. Every year, 15 million new stroke patients are added globally, and about 50% of them face swallowing difficulties during hospitalization, with 13% developing long-term swallowing disorders.
For patients with swallowing difficulties, the current treatment requires grinding the tablet into powder, mixing it with water, and taking it twice daily for a lifetime. This method is not only time-consuming and labor-intensive but also leads to inaccurate dosing and increases the risk of choking and aspiration pneumonia. In contrast, TAHO's TAH3311, developed with the proprietary TDS technology, only requires placing the oral dissolving film on the tongue, where it rapidly dissolves without the need for water, addressing an unmet clinical need and significantly reducing the burden on patients and caregivers.
According to IQVIA statistics, Apixaban's sales in the U.S. are expected to reach $26.1 billion in 2024, making it the world's top-selling small-molecule drug. The global anticoagulant market continues to grow. Due to patent litigation victories by the original manufacturer of Apixaban, settlements have been reached with only a few generic drug manufacturers, with these generics expected to begin selling in April 2028. If TAH3311 receives drug approval as expected, it will be able to compete with the original manufacturer. TAHO Pharmaceuticals is actively seeking global partners to accelerate the international launch of TAH3311.
Resource: 挑戰全球最暢銷化學新藥 泰合口溶膜新藥樞紐試驗達標
