康希諾(688185.SH):新型冠狀病毒mRNA疫苗獲批開展臨牀試驗
格隆匯4月5日丨康希諾(688185.SH)公佈,近日,公司收到國家藥監局核准簽發的《藥物臨牀試驗批件》,公司在研產品新型冠狀病毒mRNA疫苗的臨牀試驗申請獲得批准,該疫苗由公司及下屬公司康希諾(上海)生物科技有限公司共同申請。適應症為預防新型冠狀病毒感染所致疾病(COVID-19)。
以原型株為基礎開發的新冠疫苗對於不斷出現的變異株的中和抗體滴度和保護率均有不同程度的下降。因此,公司與下屬公司康希諾(上海)生物科技有限公司共同開發了新型冠狀病毒mRNA疫苗,是對現有變異株有保護效果的新一代疫苗,臨牀上擬用於預防新冠肺炎。臨牀前研究結果顯示,該款疫苗可以誘導出針對多種WHO認定的重要變異株(包括當前流行株)的高滴度的中和抗體,與以原型株為基礎開發的新冠疫苗相比廣譜性更強,可以更有效地保護機體免受現有變異株的感染。
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