Taiwan's Leading Allogeneic Cell Biotech, UnicoCell Biomed (6794), Steps onto TIB (Taiwan Innovation Board) and is Successfully Listed on the Taiwan Stock Exchange on 21st May, 2024.
UnicoCell Biomed Co., Ltd. (UnicoCell, 6794) is officially listed on the Taiwan Stock Exchange Innovation Board (TIB) on 21st May and who is the first company on the TIB focus on allogeneic stem cell new drug development and brings fresh blood into the biotech industry cluster of TIB.
UnicoCell specializes in the development and application of allogeneic adipose stem cell new drugs in the field of Regenerative Medicine. Since UnicoCell has been established over 10 years, the research and development team has been focusing on meeting the medical needs of irreversible diseases such as aging and degeneration. UnicoCell’s targeting clinical indications hold significant global market potential. Among them, the clinical trial for treating Knee Osteoarthritis is currently in Phase III enrollment, and the end of trial notification submission of the phase I/II clinical trial for chronic kidney disease is under reviewing by the regulatory authority. The progressions of both clinical trials are ahead of domestic and international counterparts, and we comprehensively pursue the international requirements from new drug research and development to manufacturing cell and cell-related production; also, the ongoing clinical trials have been approved by both the TFDA (Taiwan Food and Drug Administration) and the U.S. FDA (Food and Drug Administration). The allogeneic stem cell new drug is originated from the allogeneic cell bank established by UnicoCell. Our allogeneic cell bank is the only one which has received US FDA's raw material Master File acknowledgement in Taiwan. Additionally, UnicoCell has completed the construction of a PIC/S GMP- compliant cell production plant. Recently, UnicoCell has just obtained an Accreditation Certificate of Foreign Cell Processor as a cell processing facility from Japan MHLW (Ministry of Health, Labor and Welfare). These affirmations validate UnicoCell's rigorous adherence to international requirements. And UnicoCell’s allogeneic stem cell bank and cell production plant with international accreditation qualifications are capable of contribute to the development of CDMO (Contract Development and Manufacturing Organization) services.
In addition to the research and development of new drugs, UnicoCell also expands our business into the application of stem cell technology. UnicoCell’s high-concentration stem cell secretome containing enriched exosome has been exported as raw materials for cosmetics to Japan. Furthermore, the company has successfully developed the patented cryogenic vial UnicoVial®, which is one of the few drug containers in the world with approval of TFDA Class 2 medical device. Qualified medical device-grade cryogenic vial is bound to become a regulatory requirement for safety; therefore, our patented cryogenic vial UnicoVial® provides a significant competitive advantage in capturing the global market for biological drug storage. Taking all achievements into account, UnicoCell has diversified our development from stem cell new drug research and development to manufacturing and drug container design.
According to statistics from the MOHW (Ministry of Health and Welfare), the prevalence of knee joint degeneration in Taiwan is 15%. According to data released by the United States Renal Data System in 2023, Taiwan has the highest prevalence of dialysis in the world. According to WHO (World Health Organization), there are over 350 million people worldwide suffering from knee osteoarthritis, while kidney-related diseases rank among the top 10 causes of death globally. Therefore, the treatment markets for knee osteoarthritis and chronic kidney disease in Taiwan and globally are enormous. UnicoCell focuses on advancing towards NDA (new drug applications) and obtaining drug certificates which is based on our leading clinical progresses. Meanwhile, the domestic legislation on regenerative medicine is also under review in the Legislative Yuan. UnicoCell is poised to seize the opportunity to obtain provisional drug license due to our completed Phase II clinical trial. In the future, UnicoCell will seek cooperation partners overseas through licensing out, taking the leading position in capturing the treatment market of new drugs for Knee Osteoarthritis and Chronic Kidney Disease. The development of UnicoCell is highly anticipated and deserving of attention.
For more information, please refer to the following link
Contact: Terry Lee
Phone: 886-2-27922699
Mail: info@unicocell.com