石藥集團(01093.HK):沙庫巴曲纈沙坦鈉片獲藥品註冊批件
格隆匯8月24日丨石藥集團(01093.HK)發佈公吿,公司附屬公司石藥集團歐意藥業有限公司開發的沙庫巴曲纈沙坦鈉片(50mg、100mg、 200mg)已獲得中國國家藥品監督管理局頒發的藥品註冊批件,並視同通過仿製藥質量和療效一致性評價。
該產品含有腦啡肽酶抑制劑沙庫巴曲和血管緊張素受體拮抗劑纈沙坦。該產品通過 LBQ657(前藥沙庫巴曲的活性代謝產物)抑制腦啡肽酶,同時通過纈沙坦阻斷血管緊張素 II的1型受體,發揮舒張血管、預防和逆轉心血管重構和尿鈉排泄等作用。該產品用於(1) 射血分數降低的慢性心力衰竭(NYHA II-IV級,LVEF ≤ 40%)成人患者,降低心血管死亡和心力衰竭住院的風險;及(2)治療原發性高血壓。該產品的獲批將進一步豐富集團在心腦血管領域的產品線。
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