天宇股份(300702.SZ):子公司厄貝沙坦片獲得藥品註冊證書
格隆匯 1 月 25日丨天宇股份(300702.SZ)公佈,公司全資子公司浙江諾得藥業有限公司(“諾得藥業”)於2021年1月23日收到國家藥品監督管理局(“國家藥監局”)核准簽發的關於厄貝沙坦片的《藥品註冊證書》。
厄貝沙坦用於治療原發性高血壓以及合併高血壓的2型糖尿病腎病的治療,最早由法國賽諾菲製藥公司研發上市,商品名為Aprovel(安博維)。根據國家藥監局藥品審評中心網站數據查詢,截至公吿日該規格製劑除原研藥企及諾得藥業外,湖南九典制藥股份有限公司等3家企業通過一致性評價後批准上市。
諾得藥業厄貝沙坦片於2019年3月獲得國家藥監局受理,目前累計研發費用支出約830萬元。
諾得藥業此次獲得藥品註冊證書後即可在境內生產、銷售厄貝沙坦片,是公司“原料藥、製劑一體化”戰略重大階段性成果,製劑業務豐富了公司業務板塊,進一步增加公司業務收入。
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