UnicoCell Biomed Co., Ltd. (UnicoCell, Stock Code 6794) has good news once again after collaborating with Mentor-Hair Group, a global salon chain, to enter the hair care industry with exosome products. Today (March 5), UnicoCell successfully passed the inspection and obtained the PIC/S GMP pilot plant certification from the Ministry of Health and Welfare. This is making further progress for UnicoCell to the goal of a new drug approval for OA (knee osteoarthritis), which is under Phase 3 clinical trial recruitment. This achievement also opens opportunities for UnicoCell expanding into the growing CDMO market of regenerative medicine and cell therapy.
UnicoCell focuses on the research of allogeneic stem cells and new drug developments, and it is known for its excellent quality system and numerous awards. The new drug candidate for knee OA, ELIXCYTE®, is the first and only cell-based drug in Taiwan to receive the gold medal award of National Pharmaceutical Technology & Research Development Award (NPRDA), which is the only award in Taiwan joint organized by the Ministry of Health and Welfare and the Ministry of Economic Affairs.
Both clinical trials of UnicoCell, knee OA and CKD (chronic kidney disease), have been approved by the TFDA and U.S. FDA, which affirms the rigorous nature of the company and extended to its clinical trials. The phase 3 trial for Knee OA is under patient recruitment and conducted at 4 medical centers including National Taiwan University Hospital, Chang Gung Memorial Hospital, Taipei Veterans General Hospital, and Shuang Ho Hospital, this makes UnicoCell in the leading place in the cell therapy industry. And the completed Phase 1/2 trial of CKD, UnicoCell is highly motivated to move forward with the subsequent trials.
To enter the market of irreversible diseases like aging and degenerative diseases, UnicoCell is continuing to pursue drug licenses for allogeneic stem cell-based treatments. After the emforcement of the Regenerative Medicinal Products Act, the two completed phase 1/2 trials of UnicoCell may be eligible for issuance of conditional approval, which would allow the drugs to launch in the market earlier for patients who needed.
Unicocell's PIC/S GMP facility is not only designated for the in-house production for licensed medicines or conditional approval products but also plays a crucial role in supporting contracted hospitals with the collaborations under the regulation of RSMT(Regulations of Special Medical Techniques；cell therapy), assisting hospital partners in providing high standard cell therapy products for patient treatments. Additionally, this PIC/S GMP facility has successfully passed inspection by Japan’s Ministry of Health, Labor and Welfare (MHLW) and obtained certification of cell processing center (CPC).
Furthermore, Unicocell owns a human-derived stem cell bank which is the only one cell products resource in Taiwan that has received Acknowledgment letter of MF (Master File) from US FDA.
UnicoCell is an excellent partner and CDMO supplier for both domestic and international cell therapy companies resulting from the FDA acknowledged cell source and the home and abroad certified facility.
Contact: Eileen Chen
Phone: 886-2-27922699
Mail: info@unicocell.com