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康希諾(688185.SH):二價新型冠狀病毒mRNA疫苗的臨牀試驗申請獲批

格隆匯4月16日丨康希諾(688185.SH)公佈,近日,公司收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批件》,公司在研產品二價新型冠狀病毒mRNA疫苗(簡稱“二價新冠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)生物研發有限公司(簡稱“康希諾生物研發”)、康希諾(上海)生物科技有限公司(簡稱“康希諾生物科技”)共同申請。

隨着SARS-CoV-2的不斷進化,出現了具有強免疫逃逸性的變異毒株,已有新冠疫苗對變異株的中和抗體滴度和保護率均表現出較大程度的下降。因此公司與下屬公司康希諾生物研發、康希諾生物科技共同開發了二價新冠mRNA疫苗,該產品由公司第一代廣譜新冠mRNA疫苗和基於OmicronBA.4/5變體的新冠mRNA疫苗組成,臨牀上擬用於預防新冠肺炎。臨牀前研究結果顯示,二價新冠mRNA疫苗相較於單價新冠疫苗對原始毒株、OmicronBA.1、BA.2.75、BA.4/5和XBB.1具有更廣譜的中和抗體反應。該產品毒理學研究結果顯示其具有較高的安全性,臨牀開發前景良好,在保護機體免受現有變異株感染方面具有臨牀潛力。

公司當前建立的mRNA技術平台,擁有自主設計、開發的序列優化軟件,可得到影響穩定性的關鍵位點及有效提高抗原表達量的最優序列,CMC(Chemistry, Manufacturing and Controls)工藝簡練,可以縮短產品開發時間,快速實現科研成果產業化。公司mRNA疫苗生產基地一期項目設計產能1億劑,目前已進入工藝驗證階段。

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