中国的NMPA批准了JW Therapeutics的Carteyva®治疗复发性/耐药性地细胞淋巴瘤. China's NMPA approves JW Therapeutics' Carteyva® for relapsed/refractory Mantle Cell Lymphoma.

中国批准首个用于治疗复发或难治性套细胞淋巴瘤的细胞疗法。 China approves first cell therapy for relapsed or refractory Mantle Cell Lymphoma. 作为JW Therapeutics的Carteyva®,一种CD19自体化基因抗原受体T (CAR-T) 细胞免疫疗法产品,获得了中国国家医疗产品管理局 (NMPA) 的批准,用于治疗复发或不耐药的上衣细胞淋巴瘤 (r/r MCL) 的成年患者. JW Therapeutics' Carteyva®, a CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product, receives approval from China's National Medical Products Administration (NMPA) for treating adult patients with relapsed or refractory mantle cell lymphoma (r/r MCL). 批准的依据是一项关键临床研究,显示答复率和安全情况高。 The approval is based on a pivotal clinical study showing high response rates and safety profile.