貝達藥業(300558.SZ):已向CDE遞交鹽酸恩沙替尼原料藥和製劑藥學研究補充資料
格隆匯4月17日丨貝達藥業(300558.SZ)公佈,2019年12月底,公司收到國家藥品監督管理局藥品審評中心(簡稱“CDE”)簽發的關於鹽酸恩沙替尼原料藥和製劑的《補充資料通知書》,公司第一時間制訂工作計劃,全力落實推進相關研究工作,並克服新冠肺炎疫情影響,確保工作進度。
近日,經過團隊的努力工作,公司已向CDE遞交了補充資料。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。
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