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艾迪藥業(688488.SH):艾諾韋林片獲批上市
格隆匯 06-28 17:48

格隆匯6月28日丨艾迪藥業(688488.SH)公吿,公司已獲得國家藥品監督管理局於2021年6月25日核准簽發的艾諾韋林片(即:ACC007片)《藥品註冊證書》,該藥商品名為艾邦德”。

艾邦德®是全新結構的非核苷類逆轉錄酶抑制劑,為公司首個抗艾滋病1類新藥,用於治療HIV-1感染初治患者。艾邦德®的Ⅲ期臨牀研究試驗結果顯示,其抗病毒有效性與對照組的依非韋倫相當,可快速降低患者體內病毒載量,對高、低基線病毒載量抑制均有效且療效持續穩定;在安全性方面,艾邦德®能顯著減少頭暈、睡眠障礙等中樞神經系統不良反應、脂代謝指標控制良好、肝毒性和皮疹發生率低,安全性優於依非韋倫。

艾邦德®作為公司首個獲批上市的一類新藥,對公司的經營發展具有重要意義,其獲批上市標誌着公司具備了在國內市場銷售該產品的資格。

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