TAHO Pharma held its pre-listing performance briefing on December 25, announcing plans to re-enter the emerging stock market on December 30 with a reference price of NT$56 per share. Chairman and CEO Howard Lee stated that the company’s innovative antithrombotic oral dissolving film (ODF) drug, TAH3311, has entered a pivotal Phase III clinical trial in the United States. The trial is expected to be completed in the first quarter of 2025, with a goal to launch the product in the U.S. and European markets in 2026.
Founded in 2010, TAHO Pharma initially entered the emerging stock market in 2014 but delisted in 2018 to focus on business transformation. Under Howard Lee's strategic adjustments, the company pivoted to focus on developing innovative drug delivery systems as its core business.
Howard Lee explained that TAH3311 reformulates the original Apixaban antithrombotic tablet (branded as Eliquis, jointly developed by Bristol Myers Squibb and Pfizer) into an oral dissolving film that quickly dissolves in the mouth without the need for water. This is classified as a 505(b)(2) new drug application for a novel dosage form. Globally, there are 15 million new stroke patients annually, and approximately 50% experience swallowing difficulties during hospitalization. While some recover after rehabilitation, an estimated 13% suffer from long-term dysphagia.
TAH3311 recently began its Phase III clinical trial, recruiting 60 healthy participants. The trial is anticipated to conclude in the first quarter of 2025, with regulatory filings in the U.S. and Europe planned for the third quarter. TAHO Pharma aims to independently secure marketing approvals and subsequently license the product to distributors for promotion in the U.S. and European markets.
According to IQVIA data, the U.S. Apixaban market reached approximately $22.1 billion in 2023, representing a 16.4% growth from $18.9 billion in 2022, with further expansion expected. Pharmacompass data ranks Apixaban as the world’s second best-selling drug in 2023, behind only the cancer treatment Keytruda, making it the top-selling small molecule drug globally. Apixaban, a Factor Xa inhibitor, is favored for its lower dosing requirements and reduced risk of gastrointestinal bleeding compared to similar drugs. By transforming Apixaban into an oral dissolving film, TAHO Pharma seeks to address clinical limitations associated with tablets while unlocking significant market potential.
Resource: 泰合30日重登興櫃 抗栓溶膜新藥拚後年上市
