On November 27, 2025, Xunlu Bio announced that its independently developed fully human BCMA-targeted CAR-T cell therapy product Fucaso® (Equecabtagene Autoleucel) has received approval from the Hong Kong Department of Health for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have progressed after at least three prior lines of therapy.

This marks Fucaso® as the first China-developed CAR-T cell therapy product approved in Hong Kong, and also the first domestically produced ATMP (Advanced Therapy Medicinal Product) to receive international PIC/S GMP certification. PIC/S (Pharmaceutical Inspection Co-operation Scheme) comprises over 56 member regulatory authorities, including the U.S. FDA and Japan's PMDA, and its GMP standards are widely recognized as an internationally accepted quality benchmark.

This approval was based on Hong Kong's "1+" innovative regulatory mechanism, which took into consideration: Fucaso®'s prior marketing approval in Mainland China; and clinical data from the FUMANBA-1 registrational clinical study (CTR20192510; NCT05066646). The Hong Kong Department of Health independently reviewed the submitted quality, non-clinical, clinical, and manufacturing data.

Since November 2024, Fucaso® has been supplied to eligible patients in Hong Kong through the Named Patient Program (NPP) for cross-border drug supply. With this Hong Kong approval, Xunlu Bio will further expand its "Nanjing manufacturing, global supply" model to support the delivery of cell therapy products to patients across multiple regions in compliance with local regulatory requirements.