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.
Japan Application for Type 1 Regenerative Medical License
09
2024.07
Kangstem Biotech recently applied for a Class 1 regenerative medicine license from Japan's Ministry of Health, Labor and Welfare, based on cord blood stem cells.
Kangstem Biotech recently applied for a Class 1 regenerative medicine license from Japan's Ministry of Health, Labor and Welfare, based on cord blood stem cells. This license will enable the company to produce and supply allogeneic cord blood stem cells to Japanese medical institutions for the treating atopic patients.
The Japanese regenerative medicine market is predominantly focused on autologous adipose stem cell-based type 2 therapies, with no approved cares of type 1 regenerative medicine using allogeneic stem cells to date. In April, Kangstem Biotech signed a MOU with Tokyo-based Medical Care Group, specializing in immunotherapy for cancer treatment, to seek approval for the first allogeneic cord blood stem cell-based type 1 regenerative medicine in Japan.
Medical Care Group of Japan has shown optimism regarding the approval of the Type 1 regenerative medicine license, citing Kangstem Biotech's copmprehensive safety data from over 600 patients in clinical trials, as well as their GMP-compliant facilities and equipment.
Cord blood stem cells, isolated from umbilical cord blood, are the youngest and healthiest cells with superior growth and differentiation capabilities compared to fat- and bone marrow-derived stem cells. Clinical trials have demonstrated their superior therapeutic effects.
Acquiring a Class 1 regenerative medicine license will allow Furestem-AD® Inj. to be used as a treatment for atopic dermatitis even before final approval. Given that Japan has an estimated three times mor atopic patients that Korea, this presents a highly promising market opportunity. Morever, this advancement is expected to revolutionize regenerative medicine in Japan by simplifying treatment through the elimination of patient tissue cell collection.