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沃森生物(300142.SZ):收到重組新型冠狀病毒變異株疫苗(CHO細胞)境外臨牀試驗倫理批件並獲得CEPI資金資助
格隆匯 02-08 19:35

格隆匯2月8日丨沃森生物(300142.SZ)公佈,公司控股子公司上海澤潤生物科技有限公司(“上海澤潤”)自主研發的重組新型冠狀病毒變異株疫苗(CHO細胞)於近日獲得馬裏巴馬科科技大學倫理委員會批准的Ⅰ/Ⅱ期臨牀試驗倫理批件,經倫理委員會確認,同意該疫苗在馬裏開展Ⅰ/Ⅱ期臨牀試驗,評估疫苗在18歲至60歲以上健康成人中的安全性、反應原性和免疫原性。

上海澤潤研發的重組新型冠狀病毒疫苗(CHO細胞)用於預防由SARS-CoV-2感染所致的疾病。上海澤潤此前已有針對新型冠狀病毒原型株的疫苗處於Ⅱ期臨牀試驗階段,本次獲批開展臨牀試驗的重組新型冠狀病毒疫苗為針對新型冠狀病毒變異株的疫苗。

近期,歐洲藥品管理局(EMA)已經批准美國Novavax公司研發的新型冠狀病毒重組蛋白疫苗NVX-CoV2373附條件上市,世界衞生組織(WHO)、印度、印度尼西亞、菲律賓、韓國、澳大利亞等國家藥監部門也已批准了Novavax公司該疫苗的緊急使用授權,國內智飛生物、國藥集團中國生物的重組蛋白新冠疫苗也獲得了緊急使用授權。全球針對新型冠狀病毒變異株的重組蛋白疫苗目前均處於研究階段。

同時,流行病防範創新聯盟(CEPI)宣佈將向上海澤潤提供815萬美元的資金資助,用於支持上述即將在馬裏開展的Ⅰ/Ⅱ期臨牀試驗。截至目前,CEPI對上海澤潤新冠候選疫苗的資金資助累計已達2510萬美元。

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