香港批准中国首次CAR-T治疗(Fucaso), 治疗超前多位骨髓瘤患者。 Hong Kong approves China’s first CAR-T therapy, Fucaso, for advanced multiple myeloma patients.

香港卫生部已经批准了IASO Bio’s Bio’s Bio’s Fucaso (Equecabtatene Autolleucel),这是中国开发的一种抗BCMA CAR-T疗法,针对至少前三次治疗失败的成人多位骨髓瘤患者。 Hong Kong’s Department of Health has approved IASO Bio’s Fucaso (Equecabtagene Autoleucel), a China-developed anti-BCMA CAR-T therapy, for adult multiple myeloma patients who have failed at least three prior treatments. 这标志着香港首次批准来自中国的CAR-T疗法,也是首次在香港检查后获得PIC/S GMP承认的中国ATMP。 This marks the first approval of a China-origin CAR-T therapy in Hong Kong and the first Chinese ATMP to receive PIC/S GMP recognition following a Hong Kong inspection. 该批准采用了香港的 " 1+ " 途径,以中国大陆先前的核准和FUMANBA-1号审判的数据为基础。 The approval used Hong Kong’s “1+” pathway, building on prior mainland China approval and data from the FUMANBA-1 trial. Fucaso自2024年11月以来就通过一个命名的病人方案在香港提供服务,并计划在IASO Bio的“南京制造、全球供应”模式下在全球推广。 Fucaso has been available in Hong Kong since November 2024 via a named patient program, with plans to expand globally under IASO Bio’s “Manufactured in Nanjing, Supplied Globally” model.