Hong Kong Approves Breakthrough CAR-T Therapy Fucaso: A New Hope for Multiple Myeloma Patients

Published: 28 Nov 2025

Author: Precedence Research

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With Hong Kong's Department of Health awarding full BLA approval for its CAR-T therapy Fucaso (Equecabtagene Autoleucel), IASO Bio has reached a significant worldwide milestone that will significantly improve the lives of patients with relapsed or refractory multiple myeloma. This approval, one of the strongest acknowledgements to date for an advanced therapy developed in China, is important not only for the region but also for the broader field of cell therapy.

Adult patients who have received three or more previous treatment lines, including immunomodulatory medications and proteasome inhibitors, but whose disease is still progressing, are now officially eligible for Fucaso. The development of a powerful BCMA-targeting CAR-T therapy offers new hope for these people, who often have few treatment options. The approval also demonstrates Hong Kong's confidence in the treatment's quality, safety, and clinical outcomes.

A defining aspect of this decision is its alignment with Hong Kong’s “1+” regulatory evaluation framework, which evaluates both prior approvals of the drug and new clinical evidence. The therapy’s strong performance in the pivotal FUMANBA-1 clinical trial was crucial, demonstrating compelling efficacy in patients who had exhausted standard treatment options. Hong Kong’s health authorities conducted an independent and comprehensive review of clinical, manufacturing, and quality data before concluding that Fucaso met all regulatory standards.

Fucaso had been available to certain patients in Hong Kong since late 2024 through a Named Patient Program before this approval. IASO Bio intends to broaden access through its global supply model, which is produced at its Nanjing facility and is now distributed globally following formal authorization. As more approvals are sought, this regulatory victory strengthens the company's goal of expanding its CAR-T innovations into new areas.

IASO Bio, founded in 2017, has rapidly grown into a global competitor in the cell therapy space. Fucaso stands as one of its most promising innovations, a fully human anti-BCMA CAR-T therapy developed using the company’s comprehensive R&D and manufacturing platforms. The approval in Hong Kong reinforces IASO Bio’s strong momentum, marking an important step in expanding advanced, life-saving therapies to global markets.

Hong Kong's approval of Fucaso is essentially a breakthrough that expands treatment options for patients with multiple myeloma and places China-originated cell therapies on a global scale.