Note: This article does not constitute any investment opinions or recommendations; please refer to official/company announcements for accuracy. This article only provides an introduction to medical and health-related drugs, not a recommendation of treatment plans (if involved), and does not represent the platform's position.Any article reprinted needs to be authorized.
On November 27, 2025, IASO Bio announced that its self-developed fully human BCMA-targeted CAR-T cell therapy product, Fucaso® (Idecabtagene Vicleucel Injection), received approval from the Hong Kong Department of Health for marketing in China. The product is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have experienced disease progression after at least three prior lines of therapy.This marks the fact that Fokasvu® has become the first CAR-T cell therapy product independently developed in China to be approved in Hong Kong, and it is also the first domestically produced ATMP (Advanced Therapy Medicinal Product) to receive international PIC/S GMP certification.PIC/S (Pharmaceutical Inspection Cooperation Scheme) consists of more than 56 member regulatory authorities, including the U.S. FDA and Japan's PMDA, and its GMP standards are widely regarded as the internationally recognized quality benchmark.This approval is based on Hong Kong's "1+" innovative regulatory mechanism, which comprehensively considers: the previous marketing approval of Fokushu® in mainland China; clinical data provided by the FUMANBA-1 registrational clinical study (CTR20192510; NCT05066646). The Hong Kong Department of Health independently reviewed the submitted data on quality, non-clinical, clinical, and manufacturing aspects.Since November 2024, Foleucel® has been providing cross-border drug supply to eligible patients through Hong Kong's Named Patient Program (NPP). Following its approval in Hong Kong, IASO Bio will further expand its "Produced in Nanjing, Supplied Globally" model to support the provision of cellular therapy products to patients in multiple regions in compliance with local regulatory requirements.Founder, Chairman and Chief Executive Officer of IASO BioMs. Zhang Jinhua stated"This approval in Hong Kong represents an important milestone in our efforts to advance our globalization strategy. We are grateful for the independent, rigorous, and efficient review process conducted by the Hong Kong Department of Health, and we recognize the value of the '1+' mechanism in enhancing the accessibility of advanced therapeutic medicines. Moving forward, we will continue to adhere to quality and safety standards, collaborate with regulatory authorities worldwide, and make innovative cell therapies accessible to more patients."Source: IASO Bio
Mastering CAR-T Therapy, Stem Cell Therapy, Gene
Therapy,Comprehensive Information on Oncolytic Viruses and Nucleic Acid Drugs
