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中國生物製藥(01177.HK):抗感染藥"利奈唑胺葡萄糖注射液"獲通過一致性評價
格隆匯 01-07 16:35

格隆匯 1 月 7日丨中國生物製藥(01177.HK)宣佈,集團的抗感染藥"利奈唑胺葡萄糖注射液"(商品名:易瑞達)(規格:100ml及300ml)已獲中國國家藥品監督管理局頒發藥品補充申請批准通知書,獲通過仿製藥質量和療效一致性評價,為該品種國內首批通過一致性評價。

利奈唑胺葡萄糖注射液屬於惡唑烷酮類抗菌藥物,主要用於經驗性治療G+菌感染,具有機制獨特、穿透率高、抗菌譜廣、安全性高的特點,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。利奈唑胺葡萄糖注射液是2020版國家醫保目錄品種,被中華醫學會《HAP/VAP診斷和治療指南(2018版)》及《利奈唑胺抗結核治療專家共識》、世界衞生組織(WHO)《耐藥結核的治療指南》等權威指南推薦為經驗性治療G+菌感染的一線用藥。通過了一致性評價,這將有助於易瑞達的進一步市場拓展。

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