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貝達藥業(300558.SZ)收到埃克替尼術後輔助治療臨牀試驗數據核查通知
格隆匯 11-30 20:52

格隆匯 11 月 30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《藥審中心關於啟動鹽酸埃克替尼片臨牀試驗數據核查的通知》(編號:HCL20200058)。

產品名稱:鹽酸埃克替尼片;申請事項:境內生產藥品註冊;申請人:貝達藥業股份有限公司;受理號:CXHS2000030國;註冊分類:化學藥品2.4類;適應症:用於表皮生長因子受體(EGFR)基因敏感突變的非小細胞肺癌(NSCLC)患者術後輔助治療。

埃克替尼是公司自主研發的我國第一個擁有自主知識產權的小分子靶向抗癌藥,上市至今已9年有餘,自2016年開始連續4年的年銷售收入超10億人民幣。為充分挖掘埃克替尼的潛力、解決患者難題,今年公司提交了埃克替尼術後輔助治療適應症的藥品註冊申請,該申請於2020年9月22日獲得國家藥品監督管理局受理、10月22日納入優先審評程序。

現根據《藥品註冊管理辦法》有關規定,藥審中心需對埃克替尼片啟動藥品註冊核查(臨牀),相關核查任務已告知國家藥品監督管理局食品藥品審核查驗中心(“核查中心”),公司後續將按照要求向核查中心聯繫註冊核查事宜。

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