奧賽康(002755.SZ)子公司獲得注射用替莫唑胺生產註冊受理通知書
格隆匯8月19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(“江蘇奧賽康”)於近日收到國家藥品監督管理局(“藥監局”)下發的注射用替莫唑胺註冊《受理通知書》。
藥品名稱為注射用替莫唑胺;劑型為注射劑;規格為0.1g;註冊分類為化學藥品第3類;申報階段為生產。
江蘇奧賽康藥業有限公司向國家藥品監督管理局提交藥品註冊申請並獲受理。替莫唑胺是咪唑並四嗪類具有抗腫瘤活性的烷化劑,替莫唑胺最早由美國Schering-Plough公司開發,FDA分別於1999年、2009年先後批准上市了替莫唑胺膠囊、注射劑兩種劑型。注射用替莫唑胺目前已在歐盟、美國和日本等多個國家和地區上市,規格為0.1g,用於治療新診斷的多形性膠質母細胞瘤,開始先與放療聯合治療,隨後作為維持治療。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。
經查詢Cortellis數據庫,2018年替莫唑胺全球銷售額約為2.14億美元,美國銷售額約為600萬美元,美國以外銷售額約為2.09億美元。
注射用替莫唑胺目前僅有江蘇恆瑞醫藥股份有限公司於2018年12月批產,江蘇奧賽康完成了臨牀研究後遞交生產註冊申請。經查詢國內樣本醫院數據庫(PDB),國內抽樣醫院替莫唑胺膠囊銷售額約為7.29億元。
截至目前,該產品項目已投入研發費用約為 1167萬元人民幣。根據我國藥品註冊相關的法律法規要求,藥物經國家藥監局審評審批通過後方可生產上市。
注射用替莫唑胺的註冊受理標誌着該品種的研發工作進入了新的階段,如順利通過審批將進一步豐富公司產品線,增強公司市場競爭力。
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