- Business
- Genovate Biotechnology Co., Ltd. (4130.TWO) engages in the research, development, manufacture and sales of pharmaceutical preparations, drug substances and intermediates, with a focus on specialty drugs for the Taiwanese market; its core products encompass nervous system drugs, digestive system drugs, analgesic and anti-inflammatory drugs, urogenital system drugs, antimicrobial drugs including Livepro (entecavir), cardiovascular system drugs such as cilostazol formulations, acne drugs, antineoplastic drugs like Genetaxyl (paclitaxel injection), anti-diabetic drugs including DBPR108, healthcare foods and cosmetics; the company also provides clinical experimental testing services (CRO/GCP), technology export services and contract manufacturing compliant with PIC/S GMP and PMDA standards for sterile preparations. Founded in 1993 and headquartered at No. 1, First Industrial Road, Hukou Township, Hsinchu County, Taiwan, Genovate operates primarily in Taiwan with exports and partnerships extending to China, Japan, the US, Australia, Europe and New Zealand, employing approximately 191-195 staff and listing on the Taipei Exchange (TPEx) since 2012. Recent developments include plans announced in May 2024 to submit a New Drug Application (NDA) for PMR (cilostazol extended-release tablets) to the US FDA under the 505(b)(2) pathway in the second half of 2025 for intermittent claudication; in 2023, partner CSPC Pharmaceutical Group filed and had accepted an NDA for DBPR108 (DPP-4 inhibitor) with China's NMPA following Phase III trials; Synmosa Biopharma proposed acquiring a 30% stake for TWD 830 million; GVX171/GX17 (S-(+)-hydroxychloroquine enantiomer) received US FDA approval in 2022 for first-in-human trials targeting antiphospholipid syndrome; ongoing investments and joint ventures persist with NaviFUS for neuronavigation-guided focused ultrasound systems in CNS diseases via subsidiaries like Genovate NaviFUS (Australia), UniPharma for GX17, and historical ties to CSPC (2012 onward) and Otsuka for PMR in Asia-Pacific.