R-Japan Co.,Ltd. obtained the license of cell processing facility under the Act on the Safety of Regenerative Medicine from the Ministry of Health, Labour and Welfare Kinki Bureau of Health and Welfare on June 29, 2015.
The fact that R-Japan received the license of cell processing facility through the auditing from Pharmaceuticals and Medical Devices Agency (PMDA) on May 18, 2015 two months after filing the application, allows it to provide stem cell manufacturing service to medical institutions. As of November 25, 2014, according to the Act on the Safety of Regenerative Medicine, no corporations or medical institutions are allowed to manufacture or carry out banking of stem cells without the license after one year of grace period.
R-Japan currently cultures approximately 1,000 cases every month for not only for Japanese clients, but also for clients from Korea, Turkey, Vietnam, under technical support from Dr. Jeon-Chan Ra, who is a founder of Biostar Stem Cell Research Institute in Korea. A revenue increase is expected in the near future through provision of manufactured stem cells to hospitals treating stem cell therapies throughout Japan, as well as stem cells cultured upon requests from foreign hospitals.
In addition, R-Japan has planned to apply for additional cell manufacturing license to supply Endothelial Progenitor Cells (EPC) in the first half of 2016. Moreover, according to the announcement of the Japanese Ministry of Economy, Trade and Industry (as of September 2013), the Japanese government expects the domestic market of regenerative medicine therapies to total 95 billion yen in 2020 and 1 trillion yen in 2030, and up to 1 trillion yen in 2020 and 12 trillion yen in 2030 with foreign customers included. Based on the report, cancer, immune system, and cartilage regeneration are the most commonly recorded therapeutic indications. While preparing for clinical trials on RBio's JOINTSTEM for degenerative arthritis in Japan, R-Japan will not only manufacture stem cells, but also focus on promoting its own regenerative medicine as drug sales.
As of May 31, only four companies, including Takara Bio and Fuji Soft Tissue Engineering, have been formally approved by the Ministry of Health, Labour and Welfare.