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.
Articles approved by Japan's Ministry of Health and Welfare
24
2024.01
Kangstem Biotech received final approval from Japan's Ministry of Health, Labor and Welfare on March 23 for its application for approval to manufacture certain cell products.
Kangstem Biotech received final approval from Japan's Ministry of Health, Labor and Welfare on March 23 for its application for approval to manufacture certain cell products. Through this, adipose tissue will be provided by Japanese medical institutions and adipose stem cells will be isolated and cultured at Kangstem Biotech's GMP center in Korea and supplied to Japanese medical institutions.
The approval, which was granted by the Ministry of Health, Labor and Welfare of Japan as a licensed facility for manufacturing advanced biopharmaceuticals certified by the Ministry of Food and Drug Safety, came quickly, in about two months after due diligence in November.
In Japan, once a local medical institution submits a plan to provide stem cell therapy to the government and receives approval, designated institutions can culture fat and bone marrow tissue of the doctor's choice and use it to treat patients.
In particular, due to the relaxation of regulations on regenerative medicine, including the inclusion of overseas stem cell manufacturing facilities as manufacturing authorized organizations, the market size is expected to reach KRW 9 trillion by 2040 due to the high accessibility and demand for treatment from both local and overseas patients. In response,
Kangstem Biotech will target the market with differentiated and high-quality adipose stem cells based on culture technology that isolates stem cells that have never aged and exist in very small amounts in the mother's umbilical cord blood (cord blood) and its own culture medium that maintains high proliferation and uniform cell status.
Even if it is the same patient's own adipose tissue, the treatment effect may vary depending on which stem cells are utilized. Therefore, we expect to achieve higher effectiveness based on our unique culture technology that can isolate the healthiest and youngest stem cells.
In addition, we have already discussed the details of commercialization with local specialized medical institutions in Tokyo and Osaka, Japan. Through this, we will strive to realize sales as soon as possible.