百济神州(06160)：百泽安新适应症上市许可申请在中国获得受理

智通财经网2022-06-21

百济神州(06160)发布公告，中国国家药品监督管理局(NMPA)药品审评中心(CDE)已受理公司自主研发的抗PD-1抗体百泽安® (替雷利珠单抗)联合化疗，用于一线治疗肿瘤表达PD-L1的晚期或转移性胃或胃食管结合部(G/GEJ)腺癌患者的新适应症上市许可申请(sBLA)。此次上市许可申请的递交，是基于百泽安®联合化疗与安慰剂联合化疗用于一线治疗局部晚期、不可切除或转移性G/GEJ腺癌患者的...

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