TWi Biotechnology Chairperson Wu Yi-Jun stated at the shareholders’ meeting on the 6th that the merger with DuKang Pharmaceuticals will help strengthen the company’s R&D pipeline and enhance corporate value, with a positive outlook for the future. The tentative merger effective date is set for September 30, with a share swap ratio of 1:1, and the company’s capital will increase to NT$1.836 billion.
Post-merger, TWi Biotechnology will have four drugs at various clinical trial stages: one has completed Phase 1 trials in the U.S., one is undergoing Phase 2 trials in the U.S., another is in global Phase 2/3 trials, and a fourth is about to start U.S. Phase 2 trials. Once any of these drugs completes Phase 2 trials and secures commercial licensing in major global markets, TWi Biotechnology will immediately begin preparations for a stock market listing.
Wu Yi-Jun highlighted that TWi Biotechnology’s new topical drug AC-203 for treating simplex epidermolysis bullosa (EBS) is actively advancing through multinational Phase 2/3 clinical trials. So far, patient recruitment is underway in over 30 hospitals across 18 countries worldwide, with an interim analysis planned for the first quarter of next year.
The company continues to seek international licensing opportunities. Earlier this year, it signed a commercial licensing agreement with Russian pharmaceutical giant R-Pharm for the Russian Federation region, and recently signed a memorandum of understanding for commercial licensing with a major Middle Eastern conglomerate.
According to market research firm Coherent Market Insights, the global market for hereditary epidermolysis bullosa (EB) is projected to reach approximately US$4.47 billion by 2026. Simplex epidermolysis bullosa (EBS) accounts for about 56% of this market, roughly US$2.5 billion. Currently, there is no effective treatment for EBS. If TWi Biotechnology’s ongoing global Phase 2/3 trials for AC-203 are successfully completed, it is expected to become the world’s first approved drug (first-in-kind) for EBS treatment.
Additionally, TWi Biotechnology’s gel drug AC-1101 completed a U.S. Phase 1b clinical trial for treating granuloma annulare in July last year. The trial results demonstrated good safety, tolerability, pharmacokinetics, and promising therapeutic trends. The company has submitted an orphan drug designation application to the U.S. FDA.
Wu Yi-Jun added that following the merger with DuKang, the company’s product line will expand from rare and inflammatory skin diseases into the central nervous system drug field. The newly added product, NORA520, is a prodrug designed in an improved formulation to treat postpartum depression and major depressive disorder, significantly broadening the company’s new drug portfolio and substantially enhancing core asset value.
General Manager Cai Cheng-En explained that postpartum depression involves complex physical, emotional, and behavioral changes after childbirth, with a prevalence rate of about 10 to 20%. Currently, only one drug is approved for treating postpartum depression, indicating a significant unmet medical need.
According to Fortune Business Insights, the global postpartum depression market is expected to grow from US$79.9 million in 2024 to US$970 million by 2032, with a compound annual growth rate of 36.7%. NORA520 is currently in a U.S. Phase 2 clinical trial for postpartum depression treatment, with recruitment progressing smoothly and a goal to complete Phase 2 by the end of this year. The company is actively negotiating international licensing and collaboration deals to secure milestone and royalty revenues.
Looking ahead, Wu Yi-Jun emphasized the company’s commitment to advancing clinical trials for its two leading new drugs—AC-203 and NORA520—across three indications. NORA520 aims to complete its U.S. Phase 2 trial for postpartum depression by the end of this year and submit an application for a Phase 2 trial for major depressive disorder to the U.S. FDA within the same timeframe. The global Phase 2/3 trial for AC-203 targets an interim analysis in the first quarter of next year.
Resource: 安成生技合併杜康藥業 董座吳怡君：有助強化研發管線
