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Stem Cell Therapy
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CDMO Business
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Kangstem Biotech strives to develop an innovative new drug for patients suffering from rare and incurable diseases.
Details of Japan's second-class regenerative medical approval
21
2024.11
Japan has relaxed regulations on regenerative medicine, including recognizing overseas stem cell manufacturing facilities as authorized organizations, which has made treatments more accessible and increased demand among patients.
Japan has relaxed regulations on regenerative medicine, including recognizing overseas stem cell manufacturing facilities as authorized organizations, which has made treatments more accessible and increased demand among patients. Once a local medical institution submits a plan to provide stem cell therapy to the government and receives approval, the designated facility can cultivate fat and bone marrow tissue of the doctor's choice and use it for patient treatment.
In January, Kangstem Biotech received approval from the Japanese Ministry of Health, Labor and Welfare for its GMP center as a cell processing facility. The company also plans to leverage its differentiated, high-quality adipose stem cell technology, "SELAF" (a culture technique that isolates stem cells in extremely small quantities, combined with its proprietary culture medium that maintains high proliferation and uniform cell status), to target the market.
On the 20th, Kangstem Biotech received approval from Japan’s Committee for Certainly Recognized Regenerative Medicine to offer two types of regenerative medicine using adipose stem cells. With this approval, the company will provide adipose tissue from patients, isolate and cultivate adipose stem cells at its GMP center, and supply these cells to Japanese medical institutions for transplantation.
The two approved types of regenerative medicine are for chronic pain diseases, using patients' own adipose stem cells. While final approval is subject to review by the Ministry of Health, Labor and Welfare, it is generally that the final approval will follow the committee's review results. Official approval from the Ministry is expected within the year.
Following the approval process, the business is expected to commence early next year. Notably, the company has already signed contracts with local medical institutions in Tokyo and Osaka, as well as partners specializing in regenerative medicine, so it anticipates treating patients and generating revenue immediately.
Starting with this approval, Kangstem Biotech plans to expand the scope of regenerative therapies for diseases with high market demand, such as aging and osteoarthritis.
Meanwhile, the company is also in the process of reviewing the approval of a plan submitted in July for Class 1 regenerative medicine based on cord blood stem cells to treat atopy. If approved, Kangstem Biotech will supply Furestem-AD to Japanese medical institutions through its mass production system at its domestic GMP center. As a result, patients will be able to access Furestem-AD as a treatment for atopy immediately. The committee’s review results are expected as early as this year.