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悦康藥業(688658.SH):YKYY017霧化吸入劑獲批開展臨牀試驗
格隆匯 11-30 15:51

格隆匯11月30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藥物臨牀試驗批准通知書(受理號:CXHL2200916、批件號:2022LP01964),公司YKYY017霧化吸入劑符合藥品註冊的有關要求,同意該品開展臨牀試驗。

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,詳情請關注《悦康藥業集團股份有限公司關於自願披露與中國醫學科學院病原生物學研究所合作開發廣譜冠狀病毒膜融合抑制劑多肽藥物的公吿》(公吿編號:2022-003)。該產品是由43個氨基酸組成的脂肽類化合物。YKYY017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。

體內藥效學研究顯示,在攻毒後給予YKYY017霧化吸入劑治療,可顯著降低SARS-CoV-2(Delta和OmicronBA.2變異株)感染倉鼠肺部的病毒載量,並可有效緩解感染倉鼠肺部的病理損傷。毒理學研究結果顯示,YKYY017未見明顯的致毒性及相關不良反應,安全性較好。

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