Mr. Andrew Lin, Chairman of TaiRx, Inc., said yesterday (12 Sep) that TaiRx's new oral anticancer drug CVM-1118 (Foslinanib), targeting neuroendocrine tumours, has already recruited more than half of the Phase II clinical cases, which can be completed ahead of schedule by the end of this year, and that after the release of clinical data in the middle of next year, it will have the opportunity to complete the international licensing by the end of next year, and that TaiRx is planning to apply for a public listing through Taipei Exchange in 2025.
TaiRx also pointed out that in order to accelerate the development of new drug product lines and enrich operating capital, the Board of Directors has resolved to issue 20,000 common shares at NT$25 per share, raising an estimated capital of NT$500 million.
Lin said that TaiRx currently has six assets in development covering early, mid and long-term development stages, and one drug, Zelnite® selenium injection, has successfully obtained a market approval in Taiwan. He stressed that the company's biggest advantage is the team's rich experience in new drug development, very familiar with research and development technology and relevant regulations, the ability to quickly push forward a new drug to market, especially in the face of the risk of new drug development, their ability can quickly find a complementary point, accurate planning of the development strategy.
Lin said that TaiRx's CVM-1118 is the world's first anticancer drug that can inhibit the formation of vasculogenic mimicry. Currently, TaiRx's CVM-1118 is undergoing phase II clinical trials for two indications, one is for the treatment of neuroendocrine tumours and the other is for the treatment of advanced liver cancer. He explained that neuroendocrine tumour is a rare disease, with about 100,000 potential patients a year in the U.S. Since there is currently no effective treatment for it, TaiRx will apply for orphan drug designation, and will strive to complete the second phase of clinical trials before it is launched on the market, and the global market is estimated to reach $6 billion in 2030; liver cancer is the third most lethal cancer in the world, and the market is estimated to reach $7 billion in 2027; and liver cancer is the third most lethal cancer in the world.
TaiRx's another new oral anticancer drug, TRX-920, has also been approved by the FDA and TFDA this year, and is about to start Phase I clinical trials in Taiwan in the fourth quarter, hoping to find out the maximum safe dose (MTD) quickly, and then plan for the Phase II clinical trials of TRX-920 for rectal, pancreatic, or liver cancers.
According to TaiRx, this fund-raising round is mainly for the development of various drugs, including the preclinical development of a new drug for oral inflammatory bowel disease. After the completion of the phase I trial, TaiRx will target at licensing of new drug products in China and the global region, and TaiRx will apply for listing on the Taipei Stock Exchange in 2025 in addition to the Emerging Stock listing.
