Company
Business
Stem Cell Therapy
Organoid
CDMO Business
IR Resource Center
Kangstem Biotech strives to develop an innovative new drug for patients suffering from rare and incurable diseases.
GMP Center Cell Processing Facility Permit Engineer
11
2024.09
Kangstem Biotech’s GMP Center has recently received a license from the Ministry of Food and Drug Safety(MFDS) for its advanced regenerative medicine cell processing facility, in accordance with the Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals.
Kangstem Biotech’s GMP Center has recently received a license from the Ministry of Food and Drug Safety(MFDS) for its advanced regenerative medicine cell processing facility, in accordance with the Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals.
This license is a step towards entering the domestic advanced regenerative medicine business, set to begin in February 2025 with the implementation of the revised Advanced Regenerative Medicine Act. Advanced regenerative medicine involves using human cells and other methods such as cell therapy, gene therapy, and tissue engineering to regenerate, restore, or create bodily structures or functions, and to treat or prevent diseases.
According to the revised Advanced Regenerative Medicine Act, regulatory relaxations will allow clinical research for treatment purposes not only for severe rare and intractable diseases but for all diseases. However, regenerative medicine institutions must obtain research approval from the Ministry of Health and Welfare through an ethics committee, and high-risk research requires approval from the MFDS. If safety and efficacy are confirmed through clinical research, advanced regenerative medicine treatments will be permitted only for severe rare or intractable diseases, following approval from the Ministry of Health and Welfare.
Severe atopic dermatitis is classified as an intractable disease under the Advanced Regenerative Medicine Act, and Kangstem Biotech intends to use its atopic dermatitis treatment, Furestem-AD® Inj., in regenerative medicine. To this end, the company has strengthened its manufacturing and quality management systems at the GMP Center, and with the cell processing facility now approved, it plans to supply Furestem-AD to advanced regenerative medicine institutions. Additionally, there has been significant interest from various regenerative medicine institutions, leading to active discussions on clinical research.
With this cell processing facility license, Kangstem Biotech is prepared to launch its domestic advanced regenerative medicine business in the first half of next year. Based on this, the company plans to supply allogeneic and autologous stem cells using SELAF technology to regenerative medicine institutions. Moreover, having been designated as an advanced regenerative medicine cell processing facility by Japan's Ministry of Health, Labour and Welfare, Kangstem Biotech is now well-positioned to aggressively target the regenerative medicine markets in both South Korea and Japan.