UnicoCell Biomed Company Ltd. ("UnicoCell") has received Gold Award in the Medicinal Product Category of the Pharmaceutical Technology & Research Development Award, jointly organized by the Ministry of Health and Welfare and the Ministry of Economic Affairs, in recognition of its research and development of a new stem cell drug for treatment of knee osteoarthritis.
On November 30, 2021, the winners of each category were announced in the Pharmaceutical Technology & Research Development Award ceremony, a national-level award that the industry are competing to get the honor and recognition every year.
The Gold Award product ELIXCYTE®, a new stem cell drug developed by UnicoCell, has completed Phase I/II clinical trials for the treatment of knee osteoarthritis approved by the Taiwan FDA ("TFDA"), making it the leading clinical study for treament with allogeneic stem cell drugs in Taiwan. In addition, the company is also conducting a clinical trial for treatment of chronic kidney disease, and the Phase II clinical trial is currently underway.
With a decade of experiences in research and development of new stem cell drugs, UnicoCell has designed a robust build-in quality system in the laboratory which had been certified by TFDA as a Good Tissue Practice laboratory and Human Organ Storage facility, by PMDA of Japan as an overseas Cell Processing Center, and by TAF as an ISO 17025 laboratory. UnicoCell has also been certified as a qualified supplier of autologous stem cell drug to partner with hospitals to carry out treatment of osteoarthritis and difficult wounds under “The Regulation Governing the Application of Specific Medical Examination Technique and Medical Device” (RASMET). In addition, UnicoVial®, a patented cryovial developed by UnicoCell, was approved by TFDA as a class II medical device which made it the only cryovial certified as a medical device in the market for storage of cell products and biologics under ultra-low temperature. More about UnicoVial® can be found on 2021 Healthcare+ Expo Taiwan.
For more information about products and services offered by UnicoCell, please contact info@unicocell.com