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安科生物PD1注射液獲藥品注冊申請受理

來源:上海證券報 胡心宇      發布日期:2019-01-15    瀏覽量:2444
安科生物1月14日晚間披露,當日公司收到國家藥品監督管理局藥品審評中心行政許可文書《受理通知書》,公司申報的“重組抗PD1人源化單克隆抗體注射液”臨床試驗申請已獲得受理。

目前,國外已有OPDIVO(百時美施貴寶)、KEYTRUDA(默沙東)和LIBTAYO(Regeneron&sanofi)獲批上市,在黑色素瘤、肺癌、霍奇金淋巴瘤等多種腫瘤中顯示了良好的治療效果。我國也有多家企業的PD1單抗進入臨床前或臨床研究階段,截至目前已有包括OPDIVO和KEYTRUDA在內的共4款PD1單抗藥物上市。

公司稱,本次獲得受理僅是新藥研發的階段性成果,后續能否獲得國家藥品監督管理局的批準進行臨床試驗、上市尚存在諸多不確定性。
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