药明巨诺(02126.HK)治疗淋巴瘤药物获国家药监局突破性治疗药物认定

阿斯达克财经
10 Jan

药明巨诺-B(02126.HK) 公布,中国国家药监局药品审评中心已授予倍诺达®(瑞基奥仑赛注射液),用于二线治疗复发或难治性成人大B细胞淋巴瘤的突破性治疗药物认定。相关药物是药明巨诺自主开发的一款靶向CD19的自体嵌合抗原受体T细胞免疫治疗产品。
据介绍,瑞基奥仑赛注射液已被批准三项适应症,包括治疗经过二线或以上系统性治疗后成人患者的复发或难治性成人大B细胞淋巴瘤、治疗经过二线或以上系统性治疗的成人难治性或24个月内复发的滤泡性淋巴瘤,以及治疗经过包括布鲁顿酪氨酸激酶抑制剂(BTKi)治疗在内的二线以及系统性治疗的成人复发或难治性套细胞淋巴瘤。(js/u)

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