IASO Bio Announces Approval of Clinical Trial Notification for its BCMA CAR-T Product in Japan

SHANGHAI, NANJING, China and PLEASANTON, Calif., Oct. 21, 2025/PRNewswire/ -- IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative cell therapies, today announced the Clinical Trial Notification (CTN) for its independently developed fully human anti-BCMA CAR-T cell therapy was approved in Japan.

The approval of the CTN in Japan for this product indicates that Japanese regulatory authorities have recognized the clinical research data it completed in China. Based on this approval, IASO Bio can conduct a small sample size clinical study in Japan. The data generated from Japan clinical study, in combination with the existing clinical data from China, can be directly submitted to support the New Drug Application (NDA). This efficient clinical development pathway is expected to reduce R&D costs and shorten the regulatory review timeline.

Ms. Jinhua Zhang, Founder, Chairperson, and CEO of IASO Biotherapeutics, stated: "The CTN approval for our BCMA CAR-T product in Japan marks a significant milestone in our 'go global' strategy. As the world's third-largest pharmaceutical market, Japan maintains rigorous regulatory standards and high barriers to entry. This approval not only demonstrates recognition of its clinical value, but also establishes an efficient pathway for global development leveraging data from China. We are committed to accelerating the advancement of this innovative, China-developed CAR-T cell therapy to benefit patients across Japan and wider international markets."

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SOURCE IASO Bio