#China #Hong Kong #CAR-T therapy #IASO Bio #FUCASO

IASO Bio Celebrates BLA Approval of Fucaso for Multiple Myeloma Treatment

On November 27, 2025, IASO Bio, a leading biopharmaceutical company based in China, announced an important milestone in the field of oncology. The Hong Kong Department of Health granted approval for the Biologics License Application (BLA) for Fucaso (Equecabtagene Autoleucel), a novel CAR-T therapy designed specifically for adult patients suffering from relapsed or refractory multiple myeloma (R/R MM). This therapeutic option becomes particularly relevant for those patients who have already undergone three or more lines of previous treatments, including at least one proteasome inhibitor and one immunomodulatory agent.

Fucaso’s approval is historic as it is recognized as the first CAR-T cell therapy developed in China to receive authorization in Hong Kong. Moreover, it stands out as the first Advanced Therapy Medicinal Product (ATMP) from the country that has attained PIC/S GMP recognition. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) involves over 56 regulatory authorities globally, including prestigious bodies such as the U.S. FDA and Japan's PMDA, which sets rigorous standards for good manufacturing practices worldwide.

This approval is particularly significant as it was granted under Hong Kong's innovative "1+" regulatory mechanism. This approach considers approvals that have already been issued in Mainland China and relies on clinical evidence provided by the FUMANBA-1 registrational study (CTR20192510; NCT05066646). The review conducted by the Hong Kong Department of Health was comprehensive, covering submitted information related to quality, nonclinical data, clinical findings, and manufacturing processes.

Since November 2024, patients in Hong Kong have had access to Fucaso through a Named Patient Programme (NPP). With the recent BLA approval, IASO Bio has articulated its intentions to broaden its “Manufactured in Nanjing, Supplied Globally” operations model. This strategy aims to facilitate patient access to Fucaso across various regions, adhering to local regulatory frameworks and requirements.

According to Ms. Jinhua Zhang, the Founder and CEO of IASO Bio, this approval marks a vital step in the company's global strategy. She acknowledged the meticulous and efficient review process by the Hong Kong Department of Health, emphasizing the importance of collaboration in bringing innovative therapies to patients in need. “We remain devoted to ensuring quality and patient safety while enhancing global regulatory cooperation,” she remarked.

Global Registration Progress of Fucaso

The journey toward attaining global market approval for Fucaso has been marked by several achievements:

• - In June 2023, BLA approval was received from the National Medical Products Administration (NMPA) for the Chinese market.
• - Following that, in March 2025, the Macau Pharmaceutical Administration Bureau granted its approval.
• - With the recent approval in Hong Kong in November 2025, IASO Bio is now focusing on additional approvals in Singapore and Saudi Arabia, which are currently under review. Furthermore, South Korea has already granted Orphan Drug Designation and ATMP Fast Track designation, while Japan has approved a Clinical Trial Notification. Registration efforts are still ongoing in other regions and countries.

Understanding Multiple Myeloma

Multiple Myeloma is a severe hematological malignancy that has shown increasing incidence rates globally. From an estimated 164,300 cases in 2019, the annual incidence rose to approximately 197,200 in 2024, with projections reaching 273,600 by the year 2040. In China alone, the incidence has escalated from 28,100 cases in 2019 to 31,800 by 2024. Notably, reports indicate that 30-40% of patients may progress to third-line therapy, highlighting the urgent need for effective treatment options.

About IASO Bio

Founded in 2017, IASO Bio has quickly established itself as one of the few commercial-stage biopharmaceutical companies focusing on advanced therapy medicinal products in China. The company is dedicated to harnessing cutting-edge technologies and fully integrated platforms that span the entire lifecycle of product development, from discovery through to commercialization. Their core focus remains on cell therapies and biologics targeting hematological malignancies and autoimmune diseases.

With the approval of Fucaso, IASO Bio is poised to play a pivotal role in addressing the challenges posed by relapsed or refractory multiple myeloma, setting new standards for patient care and innovation in the biopharmaceutical landscape.