Kang Stem Biotech announced on Jan. 24 that it received final approval from the Japanese Ministry of Health, Labour and Welfare on Jan. 23 for its application for recognition of the manufacture of specific cell processed products.
Through this approval, the company will receive adipose tissue from patients at Japanese medical institutions and supply adipose-derived stem cells, which are isolated and cultured at Kang Stem Biotech’s GMP center in Korea, back to the Japanese medical institutions.
This approval was swiftly obtained about two months after an inspection in November, certifying Kang Stem Biotech as a manufacturing facility authorized by the Japanese Ministry of Health, Labour and Welfare, holding the Korea Food and Drug Administration’s certification for advanced biopharmaceutical manufacturing.
In Japan, local medical institutions can culture adipose and bone marrow tissues as desired by doctors for patient treatment once their stem cell therapy plans are approved by the government. Particularly, the inclusion of overseas stem cell manufacturing facilities as recognized manufacturers and the relaxation of regulatory measures for regenerative medicine are expected to enhance treatment accessibility and demand among both local and international patients, with the market size projected to reach 9 trillion won by 2040.
Kang Stem Biotech aims to penetrate the market with high-quality adipose-derived stem cells, utilizing its unique culture technology that isolates stem cells that have never aged found in minute quantities in the umbilical cord blood of mothers, along with its proprietary culture medium that maintains high proliferation rates and uniform cell states.
A representative from Kang Stem Biotech said, “The therapeutic effects can vary depending on which stem cells are utilized, even if they are from the same patient’s autologous adipose tissue.” They further expressed, “Based on our unique culture technology capable of isolating the healthiest and youngest stem cells, we anticipate achieving higher efficacy.”