UnicoCell Biomed Co., Ltd. (referred to as "UnicoCell"), a leading Taiwanese cell therapy developer, received official notification from the Ministry of Health and Welfare (MOHW) on October 1, 2026, confirming that the allogeneic human adipose-derived stem cell (UC-hADSC) has been granted an Export License (License No. 000164). This represents UnicoCell among the first cell therapy companies in Taiwan to secure an Export License for cell-based products. This achievement not only marks a major regulatory milestone following the implementation of Taiwan’s Regenerative Medicine Acts, but also provides strong momentum for UnicoCell’s global market expansion.UnicoCell’s core stem cell raw materials have been developed under the highest industry standards for long time. The allogeneic stem cell sources strictly adhere to International Council for Harmonisation (ICH) screening guidelines, representing top-tier pharmaceutical-grade specifications. Furthermore, UnicoCell has successfully registered U.S. FDA Master File (MF) across its entire value chain—from upstream cell sources to downstream derivatives. Coupled with its PIC/S GMP pilot manufacturing facility, UnicoCell has fully integrated a end-to-end supply chain spanning raw material sourcing, manufacturing, clinical development, and international export.Yi-Wen Tsai, President of UnicoCell, stated: "Securing this Export Drug License is a strong reaffirmation from TFDA of our quality control, product safety, and international-grade manufacturing standards. This license will serve as a solid foundation as we advance our overseas commercialization and establish partnerships with global medical institutions and biotech firms."UnicoCell’s new drug (ELIXCYTE-OA) has completed patient enrollment for its Phase 3 clinical trial for knee osteoarthritis and continues to advance clinical trials for other core drug candidates, including ELIXCYTE-CKD for chronic kidney disease. With the Export License now secured, the company will actively expand the global reach of its exosome and cell-based products, accelerating international deployment and driving cross-border business development for its innovative stem cell therapies.
Contact: CFO Daniel Ho
Phone: 886-2-27922699
Email: info@unicocell.com