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麗珠集團(000513.SZ):重組新型冠狀病毒融合蛋白二價(原型株/Omicron XBB變異株)疫苗(CHO細胞)納入緊急使用
格隆匯 12-03 16:42

格隆匯12月3日丨麗珠集團(000513.SZ)公佈,2023年12月1日,公司控股附屬公司珠海市麗珠單抗生物技術有限公司收到國家相關部門的函件,麗珠單抗研發生產的重組新型冠狀病毒融合蛋白二價(原型株/Omicron XBB變異株)疫苗(CHO細胞)經國家衞生健康委提出建議,國家藥品監督管理局組織論證同意納入緊急使用。本品是繼重組新型冠狀病毒融合蛋白疫苗(麗康V-01)之後,公司第二款被國家納入緊急使用的新冠疫苗產品。

本品已按國家藥監局批准的臨牀方案進行臨牀試驗,截至目前,已完成全部受試者入組(共4750例,其中老年受試者2002例),達到臨牀預設的主要研究終點。臨牀試驗結果顯示,本品接種後7天中和抗體滴度快速升高,接種後14天中和抗體滴度達到峯值,接種後28天仍維持在相當水平,對XBB.1.9.1的活病毒中和抗體滴度為407.9,顯著優效於對照原型苗V-01,老年組與成年組中和抗體滴度相當。同時,本品對EG.5.1、XBB.1.9.1、XBB.1.16、XBB.1.5等多種流行變異株均有廣譜中和效果,提示本品對當前主要流行毒株有很好的保護作用。本品安全性良好,不良事件主要為輕度常見不良事件,總體發生率低,且老年組不良事件發生率較成年組更低,與原型苗V-01相比未增加新的風險。

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