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艾迪藥業(688488.SH):ACC008上市許可申請獲受理
格隆匯 05-19 17:00

格隆匯5月19日丨艾迪藥業(688488.SH)公佈,公司收到國家藥監局於2021年5月19日簽發的關於公司抗艾滋病領域在研1類新藥ACC008片(複方ACC007片,以下簡稱“ACC008”)境內生產藥品註冊上市許可申請的《受理通知書》。

在研抗艾滋三聯單片複方製劑ACC008,是公司在ACC007的基礎上,聯合2個核苷類逆轉錄酶抑制劑(拉米夫定和替諾福韋)開發的國產首款三合一單片複方創新藥製劑,其組合方案及藥物選擇符合國際趨勢,於2019年12月被列入國家十三五“重大新藥創制”科技重大專項。HIV患者每天僅需服用1片,無需再服用其它抗艾滋病藥物,有助於減輕患者服藥負擔,增加依從性,減少耐藥發生,可為國內患者提供一個國際同步的新選擇。

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