Fucaso® from IASO Bio approved in Hong Kong for treating relapsed or refractory multiple myeloma

On November 27, 2025, IASO Bio announced that its self-developed fully human BCMA-targeting CAR-T cell therapy Fucaso® (Equecabtagene Autoleucel Injection) has been approved for marketing by the Department of Health of Hong Kong, China. The therapy is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have experienced disease progression after at least three prior lines of therapy.

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

This approval is based on Hong Kong's "1+" innovative regulatory framework, which took into comprehensive consideration: Fucaso®'s prior marketing approval in Mainland China; and the clinical data provided by the FUMANBA-1 registration clinical study (CTR20192510; NCT05066646). The Hong Kong Department of Health conducted an independent review of the submitted documentation covering quality, non-clinical, clinical, and manufacturing aspects.

Since November 2024, Fucaso® has been supplied cross-border to eligible patients in Hong Kong through a Named Patient Program (NPP). Following this approval in Hong Kong, IASO Bio will further expand its "Manufactured in Nanjing, Supplied Globally" operational model to support the provision of its cell therapy products to patients in multiple regions, in compliance with local regulatory requirements.