UnicoCell Biomed Co., Ltd. (hereinafter referred to as UnicoCell) (6794), a biopharmatheutical company specializing in human allogeneic stem cells in regenerative medicine, applied to Taiwan Stock Exchange (TWEX) for listing and trading stock on Taiwan Innovative Board (TIB) on November 28th. UnicoCell is the 10th company applied for TIB this year. Under TWEX strategy of actively building biotech companies listed in TWEX, UnicoCell has strong potential to be listed with the support from Horizon Securities Co., LTD.
UnicoCell was established in 2018. The current capital is NT$545 million. UnicoCell focuses on stem cell research and drug development, human allogeneic adipose-derived mesenchymal stem cells, ELIXCYTE®, for multiple medical applications. The capabilities of stem cells include regeneration, multipotency and tissue repair. Stem cell therapy is highly anticipated in regenerative medicine, especially to fulfill the unmet needs of irreversible degenerative diseases in aging societies.
Current on-going clinical trials had been approved by both Taiwan Food and Drug Administration (TFDA) and The United States Food and Drug Administration (US FDA). Phase III clinical trial for ELIXCYTE® treating knee osteoarthritis (OA) has been under recruting. Another spark of interest, phase I/ II clinical trial results of ELIXCYTE® treating chronic kidney disease (CKD) is under data analysis. There are large unmet needs worldwide in Knee OA and CKD treatment. UnicoCell has strong advantages on both knee OA and CKD treatment with lead clinicals progress globally. UnicoCell is the only cell company that received the acknowledgement letter of Master file (MF) from US FDA for the allogeneic adipose stem cell bank in Taiwan. The recognition demonstrates UnicoCell’s rigorous standards meet the international requirements for safety and quality of new drugs. Moreover, UnicoVial®, the only cryogenic vial obtains Medical Device Class II license from TFDA and Drug Master File (DMF) acknowledgement letter from US FDA in 2023. UnicoVial covered by multinational patent has been launched in the market and driven the company growth.
Exclusive UnicoCell secret factors, the well-qulified source of exosome, with manufacturing patent has obtained 4 International Nomenclature Cosmetic Ingredient (INCI) name since 2017 and is successfully expanded to Japan and other overseas collaborators. Moreover, with UnicoCell’s QC lab certified by ISO17025 which is beneficial for in-house quality control and for providing test services to others. In addition, PIC/S GMP compliant plant of UnicoCell has been constructed for new drug development. UnicoCell, equipped with comprehensive research and development capabilities with wide medical applications of allogeneic stem cell drug development, is a rising star in Taiwan regenerative medicine.
Contact: Terry Lee
Phone: 886-2-27922699
Mail: info@unicocell.com