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中國生物製藥(01177.HK)旗下抗菌藥"利奈唑胺葡萄糖注射液"獲通過一致性評價
格隆匯 06-02 21:30

格隆匯6月2日丨中國生物製藥(01177.HK)宣佈,集團研製的抗菌藥"利奈唑胺葡萄糖注射液"(商品名:天禮)已獲中華人民共和國國家藥品監督管理局頒發藥品補充申請批准通知書,通過了仿製藥質量和療效一致性評價。利奈唑胺用於治療由特定微生物敏感株引起的下列感染:院內獲得性肺炎,社區獲得性肺炎,複雜性皮膚和皮膚軟組織感染,非複雜性皮膚和皮膚軟組織感染,萬古黴素耐藥的屎腸球菌感染。

利奈唑胺屬於惡唑烷酮類抗菌藥物。其作用機制獨特,對多種臨牀致病的革蘭氏陽性(G+)菌有效,具有抗菌譜廣、體液和組織穿透性強、安全性高等特點,與其他抗菌藥物(如頭孢菌素類、喹諾酮類或β內醯胺類抗生素)間幾乎沒有交叉耐藥性,在呼吸、血液、重症加強護理病房(ICU)、結核╱傳染等科室廣泛使用。

易瑞達(集團另一個早前獲通過一致性評價的利奈唑胺產品)和天禮相繼過評,這將有助於集團利奈唑胺產品的進一步市場拓展。

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