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悦康藥業(688658.SH):YKYY017霧化吸入劑取得用於預防新型冠狀病毒感染臨牀試驗批件
格隆匯 12-26 16:50

格隆匯12月26日丨悦康藥業(688658.SH)公佈,公司於近日獲得國家藥品監督管理局核准簽發關於YKYY017霧化吸入劑用於預防新型冠狀病毒感染的《藥物臨牀試驗批准通知書》(受理號:CXHL2200935、通知書編號:2022LP02145),將於近期開展I期臨牀試驗。

YKYY017霧化吸入劑是公司與中國醫學科學院病原生物學研究所合作開發的最新一代廣譜、高效的冠狀病毒膜融合抑制劑,公司擁有YKYY017全球獨佔權益。該產品是由43個氨基酸組成的脂肽類化合物,通過與新冠病毒S蛋白S2亞基的七肽重複序列區1(HR1)相互作用形成異源六螺旋束(6‑HB),從而抑制病毒本身HR1和HR2結構域之間同源6‑HB的形成,阻斷病毒與宿主細胞的融合過程,進而達到抗病毒目的。

體外藥效學研究顯示,YKYY017對新型冠狀病毒原始株及其多種流行變異株(Delta、OmicronBA.1、OmicronBA.2、OmicronBA.4及OmicronBF.7)均有顯著的抑制效果,不受病毒變異影響,具有廣譜性。體內藥效研究結果表明,攻毒感染前不同時間點給藥,YKYY017霧化吸入劑均可顯著抑制新型冠狀病毒在肺組織中的複製,表現出對新型冠狀病毒優良的預防作用。現有研究結果表明,該產品對新型冠狀病毒感染兼具治療和預防雙重作用,安全性良好。

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