智通财经APP获悉,百济神州(06160)涨超3%,截至发稿,涨3.28%,报110.1港元,成交额1.62亿港元。
消息面上,12月27日晚,百济神州宣布,美国食品药品监督管理局(FDA)已批准百泽安®(替雷利珠单抗)联合含铂和氟尿嘧啶类化疗用于肿瘤表达PD-L1(≥1)的不可切除或转移性HER2阴性胃或胃食管结合部(G/GEJ)癌成人患者一线治疗。新适应症基于全球3期试验结果,证明百泽安®联合化疗可显著改善晚期胃癌患者的总生存期。据悉,这是FDA在2024年授予百泽安®的第二项批准。
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