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's Commentary: IASO Biotechnology's Milestone in CAR-T Therapy

IASO Biotechnology's recent achievement of obtaining the biologics license application (BLA) approval from the Hong Kong Department of Health for Fucaso (Equecabtagene Autoleucel) represents a major breakthrough in the field of gene and cell therapies. This fully human anti-B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) therapy is specifically designed for adults with relapsed or refractory multiple myeloma (R/R MM) who have exhausted other treatment options. The approval highlights the growing prominence of Chinese biotech companies in the global therapeutics space, especially with the increasing recognition of their innovative therapies by international regulatory bodies.

The authorization of Fucaso as the first CAR-T therapy developed in China, and the first China-origin advanced therapy medicinal product (ATMP) to gain Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP recognition, underscores China's rising influence in global biotechnology. PIC/S is a critical standard in ensuring the manufacturing quality of medicinal products, and Fucaso’s success in meeting these criteria reflects the high-quality production and rigorous testing protocols followed by IASO Biotechnology.

IASO’s use of the "1+" innovative regulatory pathway, which leverages prior BLA approval in Mainland China and integrates international clinical trial data, has proven to be a successful model for accelerating the availability of cutting-edge therapies in Hong Kong. This regulatory approach not only fast-tracks the approval process but also highlights the importance of global collaboration in making advanced treatments more accessible to patients worldwide. The inclusion of the FUMANBA-1 trial data was pivotal in proving the clinical efficacy of Fucaso in treating R/R MM patients.

Looking ahead, the company’s international expansion strategy seems to be well on track, with reviews underway in Saudi Arabia and Singapore, and approval granted in Macau in March 2025. IASO’s approach to developing and registering its products internationally shows a clear commitment to broadening access to novel cell therapies and improving treatment outcomes for multiple myeloma patients globally. The ongoing commitment to high standards of safety and quality is crucial as they continue their global push.

Sources:

• IASO Bio gains Hong Kong approval for Fucaso application