UnicoCell Biomed Co., Ltd. (Stock Code: 6794, "UnicoCell") received approval from the Taiwan Stock Exchange Corporation on July 28, 2025 to transfer from the Taiwan Innovation Board (TIB) to the General Board, becoming Taiwan's first biotechnology company to successfully complete board transfer. During the transfer process, UnicoCell obtained an opinion letter from the Industrial Development Administration, Ministry of Economic Affairs, certifying the company as "a technology enterprise with marketability," demonstrating government recognition of UnicoCell's technological innovation capabilities and market prospects. The transfer to the General Board will enhance the company's visibility in the international markets, facilitate international business collaborations, and strengthen UnicoCell's position in the field of regenerative medicine
UnicoCell specializes in developing allogeneic adipose stem cell therapeutics to address the unmet medical needs in aging-related and irreversible degenerative diseases. The company's core product, ELIXCYTE®, for the treatment of knee osteoarthritis (OA) is currently in Phase 3 clinical trial patient recruitment at leading medical centers including National Taiwan University Hospital, Chang Gung Memorial Hospital, Taipei Veterans General Hospital, and Shuang Ho Hospital. Another clinical trial for chronic kidney disease (CKD) has completed Phase 1/2 review and received Fast Track Designation from the U.S. Food and Drug Administration (U.S. FDA) in March this year, demonstrating FDA's recognition of ELIXCYTE®'s potential as an innovative therapy for chronic kidney disease, with preparations actively underway for the next phase. Both clinical trials demonstrate industry-leading progress and have received regulatory approval from both the Taiwan Food and Drug Administration (TFDA) and U.S. FDA, reflecting UnicoCell's strict adherence to international regulatory standards.
UnicoCell operates Taiwan's only allogeneic cell bank with US FDA Master File(MF) acknowledgement. The company also has a PIC/S GMP-certified cell therapy manufacturing facility and holds an Accreditation Certificate of Foreign Cell Processor from Japan's Ministry of Health, Labor and Welfare (MHLW). These achievements form a robust international quality management system and lay a solid foundation for its Contract Development and Manufacturing Organization (CDMO) services. UnicoCell’s technology applications are highly diversified. Its high-concentration stem cell-derived exosomes have been successfully exported to Japan as cosmetic raw materials. Additionally, UnicoCell has formed a strategic partnership with Mentor Group to expand into the hair care market.
As domestic regulations under the Regenerative Medicine Products Act continue to be refined, UnicoCell is well-positioned to potentially secure conditional approval for provisional drug licensing ahead of competitors, given its completed Phase 2 clinical trials. This could significantly accelerate product commercialization timelines. According to data from the Ministry of Health and Welfare (MOHW), the prevalence of knee osteoarthritis in Taiwan is around 15%, representing a substantial patient population. Additionally, Taiwan has the highest dialysis prevalence rate in the world, while chronic kidney disease ranks among the top ten global causes of death, underscoring both the urgent medical need and substantial market opportunity.
Following the General Board transfer, UnicoCell will continue advancing stem cell technology research and development, actively expand into international markets, and developing strategic partnerships to establish itself as a global leader in regenerative medicine.
Contact: Ray Liu
Phone: 886-2-27922699
Mail: info@unicocell.com