君實生物(01877.HK):JS026注射液臨牀試驗申請獲得受理
格隆匯10月28日丨君實生物(01877.HK)公吿,近日,公司收到國家藥品監督管理局核准簽發的《受理通知書》,JS026注射液(項目代號“JS026”)的臨牀試驗申請獲得受理。
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(以下簡稱“COVID-19”)的預防和治療。JS026以SARS-CoV-2刺突蛋白S1亞基為靶點,高親和力結合受體結合區域(以下簡稱“RBD”),阻斷RBD和宿主細胞表面受體血管緊張素轉化酶2(以下簡稱“ACE2”)的結合,從而進一步阻斷SARS-CoV-2侵染宿主細胞。
JS026自COVID-19康復者體內單個記憶B細胞中篩選得到,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的結合表位位於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與埃特司韋單抗(etesevimab,JS016)具有聯合用藥的潛力,以有效應對各種病毒突變。
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