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神州細胞(688520.SH):重組新冠病毒Alpha+Beta變異株S三聚體蛋白疫苗獲得藥物臨牀試驗批件
格隆匯 11-12 20:59

格隆匯11月12日丨神州細胞(688520.SH)公佈,公司控股子公司神州細胞工程收到國家藥監局核准簽發的《藥物臨牀試驗批件》,公司在研產品重組新冠病毒Alpha+Beta變異株S三聚體蛋白疫苗的臨牀試驗申請獲得批准。

CTV01C是神州細胞工程針對新冠病毒變異快、以原始株為基礎的國內外第一代疫苗對變異株中和抗體滴度和保護率下降等問題自主研發的重組新冠病毒Alpha+Beta變異株S三聚體蛋白與水包油佐劑混懸液新一代疫苗,臨牀上擬用於預防新型冠狀病毒感染所致疾病(COVID-19)。

SCTV01C的活性成分包含兩種WHO認定的主要變異株重組蛋白抗原,臨牀前藥學和非臨牀研究結果顯示,該兩種蛋白模擬了S蛋白的天然三聚體結構,具有高產量、高純度和三聚體結構穩定等特點,可誘導出針對WHO認定主要變異株的高滴度廣譜中和抗體和Th1偏向性T細胞免疫反應,且與單個變異株疫苗相比,可激發更強、更廣譜的變異株中和抗體滴度,可更有效抵禦變異株的感染風險。

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