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中國醫藥(600056.SH):奧拉西坦原料藥通過技術審評
格隆匯 02-25 17:16

格隆匯2月25日丨中國醫藥(600056.SH)公佈,近日,公司下屬全資子公司天方藥業有限公司(“天方有限”)奧拉西坦原料藥通過國家藥品監督管理局藥品審評中心的技術審評,該原料藥登記狀態為“A”(已批准在上市制劑使用的原料/輔料/包材)。

登記號:Y20170000541;品種名稱:奧拉西坦;企業名稱:天方藥業有限公司;包裝規格:25kg/桶;審批結論:通過技術審評;受理號:CYHS1300912。

奧拉西坦主要適用於腦損傷及其引起的神經功能缺失、記憶與智能障礙等症的治療。天方有限於2013年6月向國家藥品監督管理局提交了奧拉西坦原料藥及注射劑的註冊申請並獲得受理。截至公告披露日,天方有限在奧拉西坦原料藥及注射劑的研發投入約1400萬元人民幣(未經審計)。

經查詢國家藥品監督管理局藥品審評中心網站,截至目前,國內主要有蚌埠豐原塗山製藥有限公司、江蘇四環生物製藥有限公司、瑞陽製藥有限公司、石藥集團歐意藥業有限公司等十五家企業該原料藥的狀態標識為“A”,標誌着該原料藥已批准在上市制劑中使用。公司未從公開渠道獲知該原料藥的國內銷售數據。

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