As a specific content of the business alliance, Yufu BIO Medical Co., Ltd. will establish a specific cell processing facility (CPC) to manufacture RIKNKT® regenerative medicine products within the Okinawa Bio Industry Promotion Center. This includes providing technical support from various angles, cooperating to ensure smooth maintenance, and consultation services for obtaining permits and licenses for the facility. CPC is provided by Hitachi Global Life Solutions. The plan is to apply to the Ministry of Health, Labor and Welfare in December this year to start the business, and wait for approval, aiming to establish a product supply system for the facility by July 2022. After the facility is constructed, we will provide technical support for the operation of the facility, implement and license intellectual property rights including multiple patented technologies related to RIKNKT®️ to the company, and provide RIKNKT®, which has exclusive manufacturing and supply rights. We plan to provide essential ligands for GMP manufacturing*1 (glycolipid compounds (α-galactosylceramide) essential for cell culture processing), and provide regenerative medicine products mainly in Okinawa Prefecture in partnership with the company. Expand your business. RIKEN Immune Regenerative Medicine selects technical partners, including medical institutions, based on strict criteria, and RIKNKT®️ is an advanced regenerative medicine that can only be received at a limited number of medical institutions nationwide. Yufu BIO Medical Co., Ltd. will be the first partner company in Okinawa Prefecture. In the future, we plan to expand our partnerships mainly in Hokkaido and the Tohoku region, where we have no partners, and develop advanced regenerative medicine throughout the country. ◯ Riken Regenerative Medicine Immunology Co., Ltd. ◯ Yufu BIO Medical Co., Ltd. ◯ RIKNKT®️ *1 A unique synthesis method was invented by Riken Regenerative Medicine Immunology Co., Ltd., and manufactured under GMP by a domestic pharmaceutical manufacturer outsourced by the company. . GMP (Good Manufacturing Practice) refers to "good manufacturing practices" (manufacturing control and quality control standards) required of manufacturers (including foreign manufacturers) and manufacturers. Quality control refers to work related to the receipt of raw materials such as pharmaceuticals, inspection, manufacturing, product packaging, shipping management, product storage, collection processing, etc. Pharmaceutical manufacturing is stipulated to comply with the GMP ministerial ordinance based on the Pharmaceutical Affairs Law, which also applies to medical institutions that conduct clinical trials. *2 List of medical institutions that provide RIKNKT®️
Name of medical institution | Location |
Tokyo Seaside Clinic | Chiyoda, Tokyo Ward |
Medical Corporation Shinaikai Ito Clinic | Osaka City, Osaka Prefecture |
Solaria Clinic Tokyo | Chuo-ku, Tokyo |
New City Osaki Clinic, Medical Association | Shinagawa-ku, Tokyo | >
General Incorporated Association Kyushu Koseikai | Fukuoka City, Fukuoka Prefecture |
Nomura Clinic | Nagoya City, Aichi Prefecture |
Yokohama Takashima Clinic | Yokohama City, Kanagawa Prefecture |
Aoyama Medical Clinic | Minato Ward, Tokyo |
Medical Corporation Aria Roppongi Clinic | Minato Ward, Tokyo |
Mitaka Healthcare Clinic | Mitaka, Tokyo |
Medical Corporation Seishinkai Takara Clinic | Shinagawa Ward, Tokyo |
Medical Corporation Aoikai AOI International Hospital | Kanagawa Kawasaki City, Prefecture |
Sakurazaka Clinic | Minato Ward, Tokyo |
Small Internal Medicine・Cardiology Clinic | Kita Ward, Tokyo |
Ginza Athena Clinic | Chuo Ward, Tokyo |
Ginza Solaria Clinic | Chuo-ku, Tokyo |
K Medical Corporation Ginza Qvo Clinic | Chuo-ku, Tokyo |
Medical Corporation Yuken Doctor Andy's Clinic | Minato-ku, Tokyo |
Edogawa Ward, Tokyo |