奧賽康(002755.SZ):注射用替莫唑胺獲得藥品註冊證書
格隆匯 1 月 18日丨奧賽康(002755.SZ)公佈,公司的全資子公司江蘇奧賽康藥業有限公司(“子公司”)於近日收到國家藥品監督管理局(“藥監局”)核准簽發的注射用替莫唑胺《藥品註冊證書》。
根據《中華人民共和國藥品管理法》及有關規定,經審查,本品符合藥品註冊的有關要求,批准註冊,發給藥品註冊證書。
替莫唑胺為新型烷化劑類抗腫瘤藥物。替莫唑胺由先靈葆雅公司(現為默克)研發,口服制劑於1999年和2000年分別在歐盟和美國上市,隨後於2007年在中國上市;注射劑於2009年在美國和歐盟上市,隨後於2010年在日本上市,用於治療新診斷的多形性膠質母細胞瘤及常規治療後復發或進展的多形性膠質母細胞瘤或間變性星形細胞瘤。公司於2019年8月完成臨牀研究向CDE遞交了生產註冊申請,近期獲得正式批准上市,為本品國內第二家獲批上市的企業。
腦膠質瘤佔顱內腫瘤的41~44.6%,具有發病率高、複發率高、病死率高、治癒率低的特點。替莫唑胺是第二代咪唑四嗪衍生物,在體內生理環境中迅速自發轉化為活性物質,易通過血腦屏障,到達腫瘤局部的濃度較高,不會出現傳統烷化劑所致的嚴重造血功能抑制和胃腸道不良反應,且與其他藥物沒有疊加毒性,還可用於對亞硝基脲耐藥的患者。PDB數據庫顯示2019年中國樣本醫院銷售額達8.1億元,市場潛力大。
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