UnicoCell Biomed Co., Ltd. (6794) today (October 16) officially transitioned from the Taiwan Innovation Board to the General Board, becoming Taiwan's first regenerative medicine stem cell drug company to be listed on the General Board. With this completion of transition, the company aims to leverage increased visibility in the capital market to accelerate enrollment in ongoing clinical trials and strengthen its international presence, setting the stage for key operational milestones in 2026.
The company's core product, ELIXCYTE®, is expected to complete patient enrollment for its Phase III clinical trials for knee osteoarthritis within this year, progressing toward the target of trial completion by 2026. Meanwhile, its chronic kidney disease program has completed the Phase I/II clinical trial close-out review and obtained U.S. FDA Fast Track designation, with preparation underway to advance to the next clinical phase.
According to data from Taiwan's Ministry of Health and Welfare, the prevalence of knee osteoarthritis in Taiwan reaches approximately 15%, while the nation continues to have the highest dialysis rate in the world, reflecting substantial and urgent unmet medical needs. With the Regenerative Medicine Act and the Regenerative Medicinal Products Act expected to be fully implemented in 2026, cell-based therapies that have completed Phase II trials may be eligible for conditional marketing authorization. Both of Unicocell's target indications are expected to qualify under this framework, positioning the company to benefit from upcoming regulatory opportunities and to capture early market advantage in regenerative medicine.
Unlike many biotech companies focused on a single segment, UnicoCell has established a fully integrated regenerative medicine value chain encompassing R&D (Research and Development), manufacturing, and commercialization. On the R&D front, the company specializes in the development of allogeneic adipose-derived mesenchymal stem cell therapeutics, targeting unmet medical needs related to aging and degenerative diseases.
In manufacturing, Unicocell has obtained PIC/S GMP certification for its facility, enabling large-scale production to support late-stage clinical trials and future commercialization. The company also provides CDMO (Contract Development and Manufacturing Organization) services for cell-based products. Furthermore, UnicoCell operates the only allogeneic cell bank in Taiwan registered with the U.S. FDA under a Master File, providing it a unique advantage in production quality assurance and international collaboration.
On the commercialization front, UnicoCell pursues a dual-track strategy of advancing new drug clinical development while simultaneously expanding its market presence, laying the groundwork for the upcoming era of regenerative medicine.
UnicoCell has established close collaborations with leading medical centers, including National Taiwan University Hospital, Linkou Chang Gung Memorial Hospital, Taipei Veterans General Hospital, and Shuang Ho Hospital. These partnerships not only ensure high-quality execution of clinical trials but also help build a strong network of physicians and patient resources to support future product commercialization.
On the commercial front, the company has formed strategic partnerships with several industry players. Among them is NeoAsia Ltd, a company with over 12 years of experience in Taiwan’s regenerative medicine and orthopedic rehabilitation market, operating an extensive network that covers major medical centers, regional hospitals, and local clinics. This collaboration will play a key role in supporting the market launch of ELIXCYTE® upon regulatory approval for osteoarthritis treatment.
In addition, UnicoCell has partnered with Mentor Group, Taiwan's largest hair salon chain, to introduce stem cell-derived Exosomes-based scalp and hair care products, which have already been launched in selected stores and will be gradually expansion to nationwide. Internationally, UnicoCell continues to export its stem cell-derived Exosomes products to Japan, and in August 2025, the company entered a strategic collaboration with Japan's New Cell Bio to expand into the South Korean regenerative medicine market. At the same time, UnicoCell is in active discussion with multiple global partners for licensing and technology transfer of ELIXCYTE®, aiming to secure potential upfront payments and milestone revenues, further accelerating its international expansion.
Following the board transition, UnicoCell will leverage capital market resources to accelerate patient enrollment in its clinical trials and strengthen its global market presence. In addition to its core new drug development programs, UnicoCell has established two key business lines, stem cell-derived Exosomes applications as well as cell technology services, to provide a stable revenue stream supporting R&D investment needs.
With clinical trial enrollment approaching completion, production facilities in place, distribution networks taking shape, and regenerative medicine regulations coming into effect, UnicoCell's strategic plans are steadily advancing. The increased visibility and financial flexibility brought by the board transition will help expedite the achievement of key operational milestones.
Looking ahead, once market authorization is obtained, UnicoCell is well-positioned to capitalize on its existing industry chain advantages to rapidly scale up production, marking a pivotal leap from R&D to profitability.
Contact: Ray Liu
Phone: 886-2-27922699
Mail: info@unicocell.com