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健康元(600380.SH):厄貝沙坦片通過一致性評價
格隆匯 12-18 15:46

格隆匯 12 月 18日丨健康元(600380.SH)公佈,近日,公司全資子公司深圳市海濱製藥有限公司(深圳海濱)收到國家藥品監督管理局核准簽發的《藥品補充申請批准通知書》,深圳海濱生產的厄貝沙坦片通過仿製藥質量和療效一致性評價(一致性評價)。

深圳海濱首次提交厄貝沙坦片一致性評價獲得受理時間為2019年09月04日,受理號為CYHB1950640。

本品適應症為治療原發性高血壓。合併高血壓的2型糖尿病腎病的治療。

截至公告披露日,厄貝沙坦片一致性評價已累計投入的直接研發費用約為人民幣1,185.03萬元。

公司厄貝沙坦片2019年度銷售收入約為人民幣2,248.18萬元。根據IQVIA抽樣統計估測數據,國內厄貝沙坦片製劑產品2019年度終端銷售金額約為人民幣21.11億元。根據國家藥品監督管理局藥品審評中心網站及鹹達數據庫顯示,截至目前,國內共有10家企業(含深圳海濱)取得了厄貝沙坦片的藥品註冊批件,其中共有9家國內企業(含深圳海濱)已通過一致性評價。

此次通過一致性評價有利於提高該藥品的市場競爭力,同時為公司後續產品開展一致性評價工作積累了寶貴經驗。

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