艾迪藥業(688488.SH):艾諾米替片Ⅲ期臨牀試驗總結報吿擬在國內外專業會議中通報
格隆匯7月31日丨艾迪藥業(688488.SH)公佈,公司於近日取得復邦德®(艾諾米替片,又稱複方ACC007片,研發項目代號:ACC008)轉換治療經治獲得病毒抑制的人免疫缺陷病毒1(HIV-1)感染者Ⅲ期臨牀試驗總結報吿(方案編號:ASL-ACC008-301),公司計劃在國內外專業會議中通報或展示此數據。
艾諾米替片系公司開發的具有自主知識產權的三聯單片複方抗HIV-1感染化學藥品1類新藥,是在公司抗HIV-1感染化學藥品1類新藥—新型非核苷類逆轉錄酶抑制劑(NNRTI)艾諾韋林片(商品名:艾邦德®)的基礎上,加入兩個核苷類逆轉錄酶抑制劑(NRTIs)—富馬酸替諾福韋二吡呋酯(TDF)和拉米夫定(3TC)所組成的複方製劑。
艾諾米替片於2022年12月30日獲得國家藥品監督管理局核准簽發的《藥品註冊證書》(國藥準字H20220033),用於治療成人HIV-1感染初治患者。作為完整抗HIV方案,艾諾米替片口服單片複方製劑的組合方案系國際國內抗HIV臨牀實踐指南推薦的標準治療方案。HIV-1感染者僅需每天服用艾諾米替片1片,無需再服用其他抗HIV藥物,可以顯著減輕患者服藥負擔,改善依從性,提高療效,減少耐藥發生。
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