In a recent article in Nikkei Biotech, the state of registration of regenerative medicine products in Japan was summarized and discussed.
At present, there are 16 products of which 2 were conditionally approved and 14 are in various stages of clinical testing. Current CAR-T-related and gene therapy studies were not included in this list. The following table is an abbreviated compilation. The original version in Nikkei Biotech contains, in addition, details on the type of clinical study and the number of participants in this study.
The article contains some sales data and discusses at length the problems concerned with addressing rare diseases, finding a clear proof of concept and other challenges concerning development and operational issues. On a positive note, the good manufacturing know-how of Japan’s industry in this field and the low risk of competition from generic successor products is emphasised.