科济药业：自研CAR-T细胞治疗产品恺力美获批上市

财中社16:53

　　6月22日，科济药业（02171）发布公告，国家药品监督管理局批准公司自主研发的Claudin18.2自体人源化CAR-T细胞治疗产品恺力美®（舒瑞基奥仑赛注射液）的新药上市申请。

　　公告指出，恺力美®用于治疗Claudin18.2阳性、人表皮生长因子受体2（HER2）阴性，至少二线治疗失败的晚期胃/食管胃结合部腺癌。同时，恺力美®是全球首款获批用于实体瘤治疗的CAR-T细胞治疗产品。

　　公司表示，正积极扩展恺力美®在癌症早期治疗和围术期治疗中的应用布局，包括一项正在中国开展的针对胰腺癌辅助治疗的I期临床试验、用于根治术后的胃/胃食管结合部腺癌患者辅助治疗后的巩固治疗的研究者发起的临床试验、用于胃/胃食管结合部腺癌一线治疗后的序贯治疗的研究者发起的临床试验。

（文章来源：财中社）

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