IASO Bio receives approval for Fucaso application in Hong Kong

IASO Biotechnology has obtained authorization from the Hong Kong Department of Health for its biologics license application (BLA) for Fucaso (Equecabtagene Autoleucel), a fully human anti-B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) therapy. The treatment is aimed at adults with relapsed or refractory multiple myeloma (R/R MM) who have previously received at least three therapies, including an immunomodulatory drug and a proteasome inhibitor.

This approval marks the first authorization in the region for a CAR-T therapy developed in China and represents the initial China-origin advanced therapy medicinal product (ATMP) to achieve Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP recognition after an inspection by the Hong Kong Department of Health. PIC/S encompasses over 56 regulatory authorities, including Japans Pharmaceutical and Medical Devices Agency and the U.S. Food and Drug Administration.

The Hong Kong approval was granted under the 1+ innovative regulatory framework, which considered prior BLA approval in Mainland China alongside clinical data from the FUMANBA-1 registrational trial. The evaluation included a thorough review of nonclinical studies, quality, manufacturing, and clinical data.

Jinhua Zhang, founder, chairperson, and CEO of IASO Biotechnology, commented: Receiving this approval in Hong Kong is a significant milestone in our international strategy. We value the thorough and efficient review by the Hong Kong Department of Health and the clarity provided by the 1+ pathway. We are dedicated to maintaining high standards of quality, patient safety, and global regulatory collaboration to expand access to innovative cell therapies worldwide.

Fucaso's international registration journey includes BLA approval in Mainland China (June 2023), with ongoing reviews in Saudi Arabia and Singapore. In March 2025, the Macau Special Administrative Regions Pharmaceutical Administration Bureau approved IASO Biotherapeutics new drug application for equecabtagene autoleucel to treat adults with R/R MM.

Author: Sophia Brooks