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君實生物(688180.SH):用於新型冠狀病毒肺炎預防和治療的JS026注射液獲批臨牀試驗
格隆匯 11-19 18:46

格隆匯11月19日丨君實生物(688180.SH)公佈,近日,公司收到國家藥品監督管理局(“國家藥監局”)核准簽發的藥物臨牀試驗批准通知書JS026注射液(項目代號“JS026”)的臨牀試驗申請獲得批准

JS026注射液是一種重組全人源單克隆抗體主要用於新型冠狀病毒肺炎(COVID-19”)的預防和治療JS026SARS-CoV-2刺突蛋白S1亞基為靶點,高親和力結合受體結合區域(“RBD”),阻斷RBD宿主細胞表面受體血管緊張素轉化酶2(ACE2)的結合,從而進一步阻SARS-CoV-2侵染宿主細胞JS026COVID-19康復者體內單個記憶B細胞篩選得到,不與人體自身抗原結合,因此其產生抗藥性抗體和毒副作用的可能性低。JS026結合表位位於RBD相對保守區域,與RBD/ACE2相互作用位點幾乎不重疊截至目前尚未發現任何RBD突變對JS026的結合產生影響,有望成為大多數病毒株的中和抗體進入臨牀試驗後,JS026 埃特司韋單抗(etesevimabJS016)具有聯合用藥的潛力,以有效應對各種病毒突變。

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