海正藥業(600267.SH):撤回厄貝沙坦氫氯噻嗪片藥品註冊申請
格隆匯4月16日丨海正藥業(600267.SH)公佈,近日,公司全資子公司瀚暉製藥收到國家藥監局關於瀚暉製藥主動申請撤回厄貝沙坦氫氯噻嗪片藥品註冊申請的《藥品註冊申請終止通知書》。
厄貝沙坦氫氯噻嗪片適用於治療原發性高血壓,該固定劑量複方用於治療單方厄貝沙坦或氫氯噻嗪不能有效控制血壓的患者。厄貝沙坦氫氯噻嗪片原研藥由賽諾菲公司研發,國內生產廠商主要有南京正大天晴製藥有限公司、浙江華海藥業股份有限公司等。
經查詢IMS數據庫,厄貝沙坦氫氯噻嗪片2019年全球銷售額約為4.68億美元,其中中國銷售額約為1.41億美元;2020年全球銷售額約為4.09億美元,其中中國銷售額為8525.45萬美元。截至目前,瀚暉製藥在該產品研發項目上已投入1159.60萬元人民幣左右。
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