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天宇股份(300702.SZ):子公司藥品厄貝沙坦片新規格(75mg)獲得批准
格隆匯 10-21 20:06

格隆匯10月21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10月20日收到國家藥品監督管理局核准簽發的關於厄貝沙坦片的《藥品補充申請批准通知書》。

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,安徽環球藥業股份有限公司、揚子江藥業集團北京海燕藥業有限公司、南京長澳製藥有限公司、瀚暉製藥有限公司及浙江華海藥業股份有限公司等5家企業通過一致性評價後批准上市。

諾得藥業厄貝沙坦片 75mg規格於2021年3月獲得國家藥監局受理,目前該品種0.15g規格及75mg規格累計研發費用支出約1188萬元。

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