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翰宇藥業(300199.SZ):HY3000鼻噴霧劑收到II期臨牀研究報吿
格隆匯 10-27 00:07

格隆匯10月26日丨翰宇藥業(300199.SZ)公佈,近日,公司收到HY3000 鼻噴霧劑 II 期臨牀研究報吿。

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 在動物體內外都表現出顯著降低新型冠狀病毒載量,對新冠病毒原始株及其多種流行變異株(Delta、Omicron BA.1、Omicron BA.2及 Omicron BA.4)具有抑制作用。預防性給藥能有效改善肺部病理變化。本品機制明確,經鼻給藥後藥物作用於冠狀病毒主要傳播路徑,與預防新型冠狀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。

本研究共計篩選 538 例受試者,篩選失敗 78 例,隨機入組 462 例,其中 459 例受試者(試驗組 232 例,安慰劑組 227 例)納入全分析數據集(FAS),參加療效分析;459 例受試者(試驗組 232 例,安慰劑組 227 例)納入安全性分析集(SS),參加安全性分析。

結論:深圳翰宇藥業股份有限公司生產的 HY3000 鼻噴霧劑在新型冠狀病毒感染高風險人羣中表現出良好的安全性和耐受性,且明確表現出具有預防新型冠狀病毒感染的療效趨勢,值得在較大樣本量人羣中進一步驗證其療效和安全性。公司將與國家藥品監督管理局藥品審評中心(CDE)溝通交流後,按照藥監部門要求開展 III 期臨牀試驗。

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