UnicoCell Biomed Co., Ltd. (Stock Code: 6794) announced that its proprietary raw material, "Human Adipose Stromal Cell Exosomes," received approval from Taiwan's Ministry of Health and Welfare (MOHW) on July 2, 2026, for use as a cosmetic ingredient.
In Taiwan, human-derived exosomes are currently permitted only for cosmetic applications, and each must undergo case-by-case regulatory review before approval. This milestone demonstrates the safety, quality, and regulatory compliance of UnicoCell’s cell-derived technology, while providing a strong foundation for the company's expansion into premium cosmetic markets in Taiwan and abroad.
Pharmaceutical-Grade Standards Backed by International Recognition
One of the key strengths of UnicoCell’s exosome products lies in their fully traceable and pharmaceutical-grade manufacturing process. From allogeneic mesenchymal stem cells to the raw material of final exosome product, the entire production chain is acknowledged by a U.S. FDA Master File (MF).
The allogeneic mesenchymal stem cells are selected according to the screening standards established by the International Council for Harmonisation (ICH), meeting the quality requirements expected for pharmaceutical manufacturing. By using pharmaceutical-grade stem cells as the starting material, UnicoCell ensures high standards of traceability, safety, and quality from the very beginning of production.
In addition to its high-quality cell source, UnicoCell 's proprietary manufacturing technology has received national recognition through the Bronze Award for Manufacturing Technology at Taiwan's National Pharmaceutical Technology & Research Development Award, jointly organized by Taiwan's MOHW and the Ministry of Economic Affairs. This patented process significantly improves the concentration and purity of UnicoCell's exosome product (INCI Tradename: UC-hEV EX), demonstrating excellence throughout the entire development process—from raw material sourcing to the final product.
Expanding into Global Markets
Alongside its regulatory approval in Taiwan, UnicoCell has established a strong international presence in the commercialization of exosome products.
- Japan: High-concentration exosome ingredients have been successfully exported to Japan since 2018 and continue to be supplied to aesthetic medical clinics and manufacturers of premium skincare serums.
- Association of Southeast Asian Nations (ASEAN): In early 2026, the company obtained a Notification of Cosmetic Product approval from the Philippine Food and Drug Administration, demonstrating compliance with the ASEAN Cosmetic Directive. UnicoCell has also entered into a strategic partnership with an overseas business group to accelerate its expansion across Southeast Asia.
- South Korea: UnicoCell has partnered with New Cell Bio Co., Ltd. (NCB) to develop the Korean market.
- Taiwan: Domestically, the company has formed a strategic alliance with Mentor Hair Co., Ltd., one of Taiwan's leading hair salon chains, expanding the application of exosome technology into premium scalp-care products.
Following the implementation of Taiwan's dual regenerative medicine regulations (Regenerative Medicinal Act and Regenerative Medicinal Products Act), UnicoCell continues to advance the conditional approval of its ELIXCYTE®—allogeneic adipose-derived mesenchymal stem cell therapy while accelerating the commercialization of its exosome cosmetic ingredients.
With progress in both regenerative medicine and advanced beauty technology, the company is well positioned to strengthen its long-term growth and create new business opportunities in domestic and international markets.
Contact: Claire Liu
Phone: 886-2-27922699
Email: info@unicocell.com