沃森生物(300142.SZ)合作研發的新型冠狀病毒mRNA疫苗獲得藥物臨牀試驗批件
格隆匯6月28日丨沃森生物(300142.SZ)公佈,公司於2020年5月11日與蘇州艾博生物科技有限公司(以下簡稱“艾博生物”)簽署了《技術開發合作協議》,各方本着優勢互補、合作共贏的原則,共同合作開展新型冠狀病毒mRNA疫苗的臨牀前研究、臨牀試驗並實施商業化生產。
公司作為共同申報方於近日收到國家藥品監督管理局批准的新型冠狀病毒mRNA疫苗《藥物臨牀試驗批件》,藥品名稱為新型冠狀病毒mRNA疫苗。
審批結論:為應對新型冠狀病毒感染的肺炎疫情,根據《中華人民共和國藥品管理法》、《中華人民共和國疫苗管理法》、《藥品註冊管理辦法》和《國家食品藥品監督管理局藥品特別審批程序》,經特別專家組評議審核,應急批准本品進行臨牀試驗,適應症為預防由SARS-CoV-2感染所致的疾病(COVID-19)。
本疫苗的研究獲得國家科技部重點研發計劃“公共安全風險防控與應急技術裝備”重點專項支持,為科技部部署的新冠疫苗5條技術路線中的“核酸疫苗”技術路線。
臨牀前研究表明,本疫苗不僅可在小鼠和食蟹猴體內誘導產生高水平中和抗體,還可誘導保護性的T細胞免疫反應。食蟹猴攻毒實驗表明,本疫苗免疫的動物可耐受高滴度新冠病毒攻擊,有效阻止病毒複製和肺病理進展,顯示出良好的保護效果。
本疫苗是中國首個獲批進入臨牀試驗階段的mRNA新型冠狀病毒疫苗,目前僅有美國、德國等少數幾個國家的新型冠狀病毒mRNA疫苗進入臨牀試驗階段。此前我國尚未批准過mRNA疫苗進入臨牀試驗。
根據國家藥品註冊的相關規定,本疫苗臨牀試驗工作後續需要開展進行Ⅰ期、Ⅱ期、Ⅲ期,具體臨牀試驗的進程和結果,公司將按照相關法規和規範性文件的規定及時履行信息披露責任和義務。
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