【科济药业-B(02171.HK)：国药监局受理舒瑞基奥仑赛注射液新药上市申请用于治疗晚期胃╱食管胃结合部腺癌】智通财经

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【科济药业-B(02171.HK)：国药监局受理舒瑞基奥仑赛注射液新药上市申请用于治疗晚期胃╱食管胃结合部腺癌】智通财经APP讯，科济药业-B(02171.HK)发布公告，中国国家药品监督管理局(NMPA)已受理舒瑞基奥仑赛注射液(产品编号：CT041，一种靶向Claudin18.2的自体CAR-T细胞产品)的新药上市申请(NDA)，用于治疗Claudin18.2表达阳性、至少二线治疗失败的晚期胃╱食管胃结合部腺癌(G/GEJA)患者。此次递交的NDA主要是基于一项在中国开展的开放标签、多中心、随机对照的确证性II期临床试验(CT041-ST-01, NCT04581473)结果。相关数据已在《The Lancet》和2025年美国临床肿瘤学会 (ASCO)年会上正式公布。

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