IASO Biotechnology has received the Hong Kong Department of Health's approval for its biologics licence application (BLA) for the fully human anti-B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) therapy, Fucaso (Equecabtagene Autoleucel), for adults with relapsed or refractory multiple myeloma (R/R MM).
The therapy is intended for patients who have undergone at least three previous therapies, including an immunomodulatory agent and a proteasome inhibitor.
The approval is the first authorisation for a China-developed CAR-T cell therapy in the region.
It also marks the first China-developed advanced therapy medicinal product (ATMP) to secure Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP recognition following Hong Kong Department of Health inspection.
PIC/S includes more than 56 regulatory authorities, which include Japan’s Pharmaceutical and Medical Devices Agency and the US Food and Drug Administration.
The Hong Kong Department of Health granted approval under the “1+” innovative regulatory mechanism, which reviewed previous BLA approval in Mainland China and clinical data from the FUMANBA-1 registrational study.
It assessed nonclinical, quality, manufacturing and clinical information in its independent evaluation.
IASO Bio founder, chairperson and CEO Jinhua Zhang stated: “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.”
Fucaso's global registration progress includes BLA approvals in Mainland China (June 2023), with reviews ongoing in Saudi Arabia and Singapore.
In March 2025, the Macau Special Administrative Region (ISAF) Pharmaceutical Administration Bureau approved IASO Biotherapeutics’ new drug application for equecabtagene autoleucel to treat adults with R/RMM.
