Iaso Bio Receives Implied Approval in Japan for BCMA CAR-T Therapy Clinical Trial Application

Oct 21, 2025 18:20 CST Updated 18:20

IASO Biotechnology

Cancer Treatment New Drug Developer

October 21, 2025, IASO Bio announced todayThe clinical trial application (Clinical Trial Notification, CTN) for its independently developed fully human targeted BCMA CAR-T cell therapy product has received implied approval in Japan.。

The recent granting of CTN implied permission indicates that Japanese regulatory authorities recognize the clinical research data completed in China. Based on this, IASO Bio can conduct a small-scale clinical study in Japan. Upon completion of the study, its data will be combined with existing data from China to form the core basis for directly submitting a New Drug Application (NDA). This efficient clinical development pathway is expected to reduce R&D costs and shorten review time.

Ms. Zhang Jinhua

Founder, Chairman and Chief Executive Officer of IASO Bio

As the world's third-largest pharmaceutical market, Japan has a rigorous regulatory system and high entry barriers. The recent implied permission for the CTN of our BCMA CAR-T product in Japan marks a key milestone in our global strategy. This not only represents a strong endorsement of its clinical value but also provides a clear pathway for us to efficiently advance global development based on data from China. We look forward to rapidly progressing so that this advanced CAR-T cell therapy, produced in China, can soon benefit patients in Japan and broader international markets.