翰宇藥業(300199.SZ):HY3000鼻噴霧劑新增適應症臨牀試驗註冊申請獲受理
格隆匯8月1日丨翰宇藥業(300199.SZ)公佈,2023年7月31日,深圳翰宇藥業股份有限公司收到國家藥品監督管理局簽發的《受理通知書》,公司HY3000鼻噴霧劑新增適應症臨牀試驗註冊申請獲得國家藥品監督管理局受理。
HY3000鼻噴霧劑是一款新型多肽膜融合抑制劑,通過與新冠病毒刺突蛋白S2亞基的HR1區域結合,阻止病毒六螺旋束結構形成,阻斷病毒侵染宿主細胞以達到抗病毒效果。
臨牀前研究顯示,HY3000在體內外都表現出顯著的抗新冠病毒作用,對新冠病毒原始株及其多種流行變異株(Delta、OmicronBA.1、OmicronBA.2及OmicronBA.4)的抑制活性顯著,且抗病毒活性不受病毒變異影響;預防性給藥能有效降低小鼠肺部病毒載量,改善肺部病變。本品機制明確,經鼻給藥後藥物主要分佈於上呼吸道,與預防新冠病毒感染的臨牀定位匹配。動物重複給藥毒性試驗顯示其具有良好安全性,無致突變風險。
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