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前沿生物(688221.SH):艾可寧獲得柬埔寨藥品註冊證書
格隆匯 09-22 17:20

格隆匯9月22日丨前沿生物(688221.SH)公佈,近日,公司核心產品艾可寧收到柬埔寨衞生部核准簽發的《藥品註冊證書》。

據悉,艾可寧是公司自主研發的國家1.1類新藥,於2018年5月獲得國家藥監局頒發的新藥證書,是全球首個獲批的長效HIV融合抑制劑,在全球主要市場具有自主知識產權。

艾可寧需與其他抗逆轉錄病毒藥物聯合使用,對主要流行的HIV-1病毒以及耐藥病毒均有效,通過注射方式每週給藥一次,具有用藥頻率低、起效快、耐藥屏障高、安全性高、副作用小等特點,為患者提供了新的用藥選擇,對部分患者具有一定的臨牀不可替代性。

根據世界衞生組織公佈的數據,截至2018年,柬埔寨存活的HIV感染者約7.3萬人,本次艾可寧在柬埔寨獲批上市,有利於產品銷售收入的增加,公司及當地合作伙伴正在積極準備艾可寧上市的推廣和銷售工作。

2021年3月,艾可寧在厄瓜多爾獲得《藥品註冊證書》,柬埔寨是艾可寧獲得《藥品註冊證書》的第二個海外國家,進一步提升了公司及產品在艾滋病治療領域的國際知名度及細分市場競爭力,有利於產品在海外市場的拓展,公司將繼續積極推進艾可寧在其他國家的藥品註冊申請工作。

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