Unicocell Biomed Co., Ltd. (6794) will hold its pre-listing performance presentation on September 23, 2025, becoming the first regenerative medicine stem cell drug company to be listed on the Taiwan’s General Board. The company’s business model focuses on three core pillars, stem cell new drug development, stem cell-derived Exosomes, and cell manufacturing technology services, to build a comprehensive regenerative medicine value chain.
The company's new drug, ELIXCYTE® (allogeneic adipose-derived mesenchymal stem cells), is being developed for two major degenerative and irreversible indications with unmet medical needs: knee osteoarthritis (ELIXCYTE®-OA) and chronic kidney disease (ELIXCYTE®-CKD). The knee osteoarthritis program in Taiwan is now nearing completion of patient enrollment in its Phase III clinical trial, which is expected to conclude in 2026, followed by trial close-out review and subsequent regulatory filing for a Biologics License Application (BLA). Meanwhile, the chronic kidney disease program has completed its Phase I/II clinical trial review in Taiwan and is progressing toward a Phase III application. Both clinical programs are advancing ahead of industry peers. Notably, the CKD program has been granted Fast Track designation by the U.S. Food and Drug Administration(FDA), underscoring international recognition of ELIXCYTE®'s therapeutic potential in treating CKD.
The Regenerative Medicine Act and the Regenerative Medicine Products Act are expected to take effect in 2026. Under these frameworks, cell therapies that have completed Phase II trials may apply for a conditional approval. Unicocell will closely align with the competent authorities on sub-regulation and implementation schedules, actively seeking conditional approvals for its osteoarthritis and chronic kidney disease indications. As a regenerative medicine company with a fully integrated value chain, Unicocell is well positioned to benefit from the new regulatory environment. Securing any such approval would allow the company to capture first-mover advantage in Taiwan, strengthen product competitiveness and pricing power, and enhance overall profitability.
Unicocell is addressing the rapidly aging global population, where degenerative age-related diseases increasingly lead to immobility, functional decline, and reduced quality of life, creating a vast and urgent unmet medical need. Leveraging stem cell technology to target irreversible diseases and improve quality of life, the company is advancing programs in osteoarthritis and chronic kidney disease while also evaluating expansion into age-related indications such as Parkinson’s disease and frailty syndrome. Unicocell operates Taiwan’s only allogeneic cell bank registered as a Master File with the U.S. FDA, a qualification that strengthens technical barriers, enhances international collaboration opportunities, and supports the company’s ambition to establish itself as a global brand in regenerative medicine.
In addition to new drug development, Unicocell is simultaneously expanding into two complementary business pillars: stem cell-derived Exosomes and cell manufacturing technology services, with revenues steadily increasing in recent years. UnicoCell’s stem cell-derived Exosomes, supported by patented processes and stable supply capabilities, is primarily used as an active ingredient in cosmetics. These products have already been successfully exported to the Japanese market and are being further expanded into Korea and Southeast Asia. In Taiwan, Unicocell has formed a strategic alliance with Mantor Group, the country’s largest hair salon chain, leveraging its extensive distribution network to promote exosome-based hair care products to a broader consumer base, with plans to extend the product line into the pet care market.
In the area of cell manufacturing technology services, Unicocell's has obtained PIC/S GMP certification for its pilot plant for cell-based medicinal products. This enables Unicocell to provide GMP-grade services including cell therapy development, large-scale production, CDMO manufacturing, and quality control testing, meeting client needs across all stages from early development to late-stage commercialization.
Market observers note that Unicocell is advancing on three growth engines: stem cell new drug development, stem cell-derived Exosomes, and cell manufacturing technology services, to establish an end-to-end regenerative medicine value chain spanning Research and Development (R&D), manufacturing, and applications. Through strategic alliances and licensing collaborations, the company is gradually expanding into overseas markets and royalty income streams. With progress in its R&D pipeline and the upcoming implementation of Taiwan’s dual regenerative medicine acts, UnicoCell’s business growth prospects remain promising.
Contact: Ray Liu
Phone: 886-2-27922699
Mail: info@unicocell.com