UNICOCELL BIOMED has officially submitted its listing application to the Taiwan Stock Exchange, following the receipt of approval as a technology-based enterprise. With two of its allogeneic adipose-derived stem cell therapies already in mid- to late-stage clinical trials, and operations showing steady progress, the company is widely expected to complete its board transition by the fourth quarter.

Specializing in regenerative medicine, UNICOCELL focuses on the development of allogeneic adipose-derived stem cell therapies aimed at addressing unmet medical needs in aging-related and degenerative diseases. The clinical indications it targets are strategically chosen to align with large global markets.

The company currently has four investigational cell therapies under development. Its most advanced candidate, ELIXCYTE, is being developed for two indications. One of them—knee osteoarthritis—has received approval from both the U.S. FDA and Taiwan TFDA to initiate Phase III clinical trials involving 165 participants. Enrollment is expected to be completed by the end of this year, with unblinding scheduled one year after completion.

Another indication—chronic nephritis within chronic kidney disease—also achieved a milestone last year, having passed regulatory review and received closure approval. In a study of 39 participants, treatment with ELIXCYTE demonstrated stable eGFR levels at both 24 and 48 weeks post-treatment, with no significant progression of chronic kidney disease. This represents the first human clinical data worldwide using cell therapy for chronic kidney disease.

UNICOCELL is now planning a formal consultation with Taiwan’s Center for Drug Evaluation (CDE) to prepare for a Phase III trial of its CKD therapy. Concurrently, the company is engaged in international licensing negotiations to advance global commercialization.

Resource: 向榮申請上市 拚Q4轉板