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貝達藥業(300558.SZ):取得鹽酸恩沙替尼註冊現場檢查通知
格隆匯 07-02 20:27

格隆匯 7 月 2日丨貝達藥業(300558.SZ)公佈,近日,公司收到國家藥品監督管理局藥品審評中心(“藥審中心”)簽發的《藥審中心關於鹽酸恩沙替尼註冊現場檢查的通知》(編號:HG20200156)和《藥審中心關於鹽酸恩沙替尼膠囊註冊現場檢查的通知》(編號:HG20200157)。

產品名稱:鹽酸恩沙替尼;申請事項:新藥申請;優先審評程序;申報適應症:用於此前接受過克唑替尼治療後進展的或者對克唑替尼不耐受的間變性淋巴瘤激酶(ALK)陽性的局部晚期或轉移性非小細胞肺癌(NSCLC)患者;申報階段:申報生產;申請人:貝達藥業股份有限公司;受理號:CXHS1800044,CXHS1800045,CXHS1800046。

鹽酸恩沙替尼的藥品註冊申請於2018年12月獲得國家藥品監督管理局受理,現已完成各專業技術審評工作及臨牀試驗數據核查工作。

基於技術審評需要,藥審中心將對公司註冊申報品種鹽酸恩沙替尼(原料藥和膠囊)組織開展註冊現場檢查,相關現場檢查任務已函告國家藥品監督管理局食品藥品審核查驗中心。

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