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山東新華製藥股份(00719.HK):腦保護劑達拉奉注射液獲得藥品註冊批件
格隆匯 03-03 16:47

格隆匯3月3日丨山東新華製藥股份(00719.HK)公佈,公司於近日收到國家藥品監督管理局核准簽發的依達拉奉注射液《藥品註冊批件》。

依達拉奉是一種腦保護劑(自由基清除劑),具有神經保護作用,可以通過清除神經系統中的自由基來減緩病情的發展,用於改善急性腦梗塞所致的神經症狀、日常生活活動能力和功能障礙。新華製藥於2013年11月向國家藥品監督管理局遞交依達拉奉注射液仿製藥藥品註冊申請資料並獲受理;2014年07月國家藥品審評中心啟動審評工作;2020年02月獲得《藥品註冊批件》。

依達拉奉由日本田邊三菱製藥研發生產,2001年在日本被批准用於治療腦卒中,商品名:Edaravon。2003年美國《缺血性腦卒中患者早期處理指南》和2004年日本的《腦卒中治療指導原則》確認其是唯一經大規模臨牀試驗證實有效的神經保護劑。2004年在中國國內獲准上市,現已被寫入國內相關用藥指南,醫保類別為乙類。經查詢,除新華製藥外,目前國內有包括原研日本田邊三菱製藥、先聲藥業、吉林博大製藥等多家企業獲批上市及銷售。

經查詢相關數據庫,依達拉奉注射液2018年全球銷售額約為6.6億美元,2018年國內147城市醫院用藥銷售額約為12.8億元。

截至目前,公司在依達拉奉注射液項目上已投入研發費用約為656.1萬元人民幣。

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