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澤璟製藥(688266.SH):收到甲苯磺酸多納非尼片藥品註冊現場核查通知
格隆匯 12-30 17:50

格隆匯 12 月 30日丨澤璟製藥(688266.SH)公佈,日,公司收到國家藥品監督管理局藥品審評中心(“CDE”)簽發的藥審中心關於啟動甲苯磺酸多納非尼片注冊現場查的通知》(編號:No.HCY20200144)根據《藥品註冊管理辦法》有關規定,CDE需對公司申報註冊的多納非尼啟動藥品註冊核查(藥學)

根據相關行政審批程序,藥品註冊批件的最終審批結果和獲批時間尚不確定,此次收到現場核查通知對公司近期業績不會產生重大影響公司將對該產品的後續進展情況及時履行信息披露義務,敬請廣大投資者謹慎決策,注意防範投資風險。

多納非尼是公司開發的口服多靶點、多激酶抑制劑類小分子抗腫瘤藥物,屬1類新藥。20205月,多納非尼的新藥上市申請(NDA)獲得國家藥品監督管理局受理。202010,多納非尼的新藥上市申請(NDA)被納入優先審評審批程序。202012月,公司收到CDE簽發的《補充資料通知》。截至公吿披露日,公司已按照要求向CDE遞交了相關補充資料。

此次收到現場核查通知表明多納非尼的註冊工作取得了重要進展,待通過臨牀和藥學現場檢查、中檢院抽樣檢驗合格,以及通過國家藥品監督管理局的審評審批後可取得註冊批件。

多納非尼一線治療晚期肝細胞癌臨牀研究結果顯示:相對於現有一線標準治療藥物索拉非尼,多非尼具有更好的療效和安全性,能夠顯著延長患者生存期,其臨牀研究結果已在具有國際影響力的美國臨牀腫瘤學會2020年會(ASCO 2020)上向全球口頭報吿。多納非尼療效確切、安全性好,已獲得臨牀專家的推薦和認可。

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