- Business
- TWi Biotechnology, Inc. TWi Biotechnology, Inc. (6610.TWO) is a clinical-stage biopharmaceutical company focused on developing novel drugs for unmet medical needs in innate immunity-related diseases, including rare dermatological disorders, arthritis, gout, diabetes mellitus, and autoimmune skin conditions; its lead product candidates include AC-203, a proprietary topical formulation that inhibits NLRP3 inflammasome activation and IL-1Beta production for epidermolysis bullosa simplex (EBS), epidermolysis bullosa (EB), arthritis, gout, and diabetes, currently advancing in Phase 2/3 clinical trials with recent regulatory approvals from authorities in Ireland, France, Belgium, Korea, Israel, Malaysia, Austria, and Poland in 2024, and AC-1101, a topical Janus kinase (JAK) inhibitor gel in Phase 1 for vitiligo and preclinical for atopic dermatitis, granuloma annulare, and other rare autoimmune skin diseases; the company employs a drug repositioning strategy leveraging existing molecules for efficient innovation targeting severe rare diseases affecting 6-8% of the global population. Founded in 2010 and headquartered at 8F, No. 41, Lane 221, Gangqian Road, Neihu District, Taipei City, Taiwan, TWi Biotechnology, Inc. operates primarily in Taiwan with a global development focus, including partnerships such as a drug development agreement with Hong Kong Winhealth Pharma Group Co., Limited for Mainland China, Hong Kong, and Macao markets, and a prior 2015 collaboration with Castle Creek Pharmaceuticals for AC-203 commercialization outside Asia; it maintains approximately 23 employees and generates contract revenue from licensing deals while building its pipeline through in-licensing and internal R&D. Recent major developments include the April 2025 announcement of a merger with Dukang Pharmaceuticals Inc. via a 1:1 share swap, positioning TWi Biotechnology, Inc. as the surviving entity to expand its pipeline with new assets like NORA520 (an oral prodrug of brexanolone), enhance R&D capabilities in the 505(b)(2) regulatory pathway, enter additional therapeutic areas, and increase paid-in capital from NT$876 million to NT$1.836 billion, with shareholder approval targeted for June 2025 and completion tentatively by September 30, 2025.