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天士力(600535.SH):吉非替尼片獲得藥品註冊證書
格隆匯 01-08 18:20

格隆匯 1 月 8日丨天士力(600535.SH)公佈,近日,公司全資子公司江蘇天士力帝益藥業有限公司品種吉非替尼片收到國家藥品監督管理局(“國家藥監局”)核准簽發的《藥品註冊證書》。

吉非替尼片於2017年2月完成BE備案,2017年11月完成BE試驗,於2018年1月申報CDE(受理號CYHS1800007),經CDE技術審評,達到與原研藥質量療效一致,再經國家審核查驗中心對研製、生產、臨牀等環節現場核查,於近日獲得國家藥監局核准簽發的《藥品註冊證書》。

吉非替尼是野生型和某些突變型EGFR的可逆性抑制劑,可抑制EGFR受體酪氨酸的自體磷酸化,從而進一步抑制下游信號傳導,阻止EGFR依賴的細胞增殖。吉非替尼由英國阿斯利康公司開發,2002年7月在日本首次上市,之後陸續在美國、歐洲上市。阿斯利康公司吉非替尼片(商品名:易瑞沙)於2004年在國內獲批上市。公司仿製藥與易瑞沙質量和療效一致。

截至目前,公司對該項目累計研發總投入1247.81萬元人民幣。

吉非替尼片獲得藥品註冊證書,視同通過一致性評價,標誌着公司在抗腫瘤治療領域又增添一個品種,進一步豐富了公司的產品管線。

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