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中國生物製藥(01177.HK)抗癌藥“注射用阿扎胞苷”獲藥品註冊批件
格隆匯 10-10 16:40

格隆匯10月10日丨中國生物製藥(01177.HK)發佈公告,由公司附屬公司正大天晴藥業集團股份有限公司開發的抗癌藥“注射用阿扎胞苷”,已獲國家藥品監督管理局頒發藥品註冊批件。該產品屬於化學藥品註冊分類第3類,且是國內首個按照美國食品藥品監督管理局頒佈的《阿扎胞苷指南草案》完成生物等效性研究,並通過了驗證性臨牀試驗的仿製藥。

阿扎胞苷為胞嘧啶核苷類似物,是一種具有雙重作用機制、目前唯一經臨牀研究證實能夠改善總生存期的去甲基化藥物。它具有作用機制明確、療效肯定、安全性高及臨牀適用廣泛等特點。阿扎胞苷適用於治療以下成年患者:國際預後評分系統中的中危-2及高危骨髓增生異常綜合症;慢性粒-單核細胞白血病;及按照世界衞生組織分類的急性髓系白血病、骨髓原始細胞為20%~30%伴多系發育異常。

阿扎胞苷適用於對骨髓增生異常綜合症的所有亞型的治療,並具有罕見病治療藥資格。對於年齡65歲以上高危老年患者,阿扎胞苷治療為首選,可使患者獲得顯着生存優勢。

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