药明巨诺倍诺达?获NMPA突破性治疗药物认定
财中社1月10日电药明巨诺-B（02126）发布公告，宣布其自主开发的倍诺达®（瑞基奥仑赛注射液）在中国获得国家药品监督管理局（NMPA）授予的突破性治疗药物认定，用于二线治疗复发或难治性成人大B细胞淋巴瘤（r/rLBCL）。该认定基于针对一线治疗失败后不适合自体干细胞移植的成人r/rLBCL患者的有效性和安全性研究，首次采用中国患者的临床试验数据支持。
倍诺达®是靶向CD19的自体嵌合抗原受体T（CAR-T）细胞免疫治疗产品，目前已获得三项适应症的批准，包括治疗r/rLBCL、复发或难治性滤泡性淋巴瘤（r/rFL）和复发或难治性套细胞淋巴瘤（r/r MCL）。该产品在中国是首个同时获得“重大新药创制”专项、新药上市申请优先审评资格及突破性治疗药物认定的CAR-T细胞免疫治疗产品，初步临床数据显示其最佳总缓解率高达84%。
（文章来源：财中社）
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