IASO Biotechnology ("IASO Bio"), a commercial-stage biopharmaceutical company dedicated to the discovery, development, manufacturing, and commercialization of novel cell therapies and biologics for hematologic malignancies and autoimmune diseases, today announced that the Biologics License Application (BLA) for its independently developed fully human anti-BCMA CAR-T therapy Fucaso (Equecabtagene Autoleucel) has been approved by the Hong Kong Department of Health. The therapy is indicated for adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received three or more prior lines of therapy, including at least one proteasome inhibitor and one immunomodulatory agent.

This approval marks the first authorization of a China-developed CAR-T cell therapy in Hong Kong (China) and the first China-developed ATMP (Advanced Therapy Medicinal Product) to obtain PIC/S GMP recognition following Hong Kong DoH inspection. PIC/S (The Pharmaceutical Inspection Co-operation Scheme) consists of more than 56 regulatory authorities, including the U.S. FDA and Japan's PMDA, and is widely regarded as a benchmark for international GMP standards.

The approval was granted under Hong Kong's "1+" innovative regulatory mechanism, which considers: Prior BLA approval of Fucaso in Mainland China; Clinical evidence from the FUMANBA-1 registrational study (CTR20192510; NCT05066646). The Hong Kong Department of Health conducted an independent review of the submitted quality, nonclinical, clinical, and manufacturing information.

Since November 2024, Fucaso has been accessible in Hong Kong through the Named Patient Programme (NPP). Following this approval, IASO Bio plans to expand its "Manufactured in Nanjing, Supplied Globally" model to support access for patients in additional regions subject to local regulatory requirements.

Ms. Jinhua Zhang, Founder, Chairperson, and CEO of IASO Bio, commented: "This approval in Hong Kong represents an important milestone in our global strategy. We appreciate the rigorous and efficient review conducted by the Hong Kong Department of Health as well as the clarity of the '1+' pathway. We remain committed to quality, patient safety, and global regulatory collaboration to bring innovative cell therapies to more patients worldwide."

Global Registration Progress of Fucaso

• Mainland China: BLA approved by the National Medical Products Administration (NMPA) in June 2023;
• Macau, China: BLA approved in March 2025 by the the Macau Pharmaceutical Administration Bureau;
• Hongkong, China: BLA approved in November 2025 by the Hong Kong Department of Health
• Singapore and Saudi Arabia: BLA under review
• South Korea: Orphan Drug Designation and ATMP Fast Track designation granted
• Japan: Clinical Trial Notification approved
• Other Countries and Regions: Registration work is ongoing