君實生物(01877.HK):JT118獲得藥物臨牀試驗申請受理通知書
格隆匯6月11日丨君實生物(01877.HK)公告,近日,公司控股子公司上海君拓生物醫藥科技有限公司收到國家藥品監督管理局覈準簽發的《受理通知書》,JT118注射液(項目代號“JT118”)的臨牀試驗申請獲得受理。
JT118是由猴痘病毒抗原A35(屬於胞外囊膜病毒抗原)和M1(胞內成熟病毒抗原)串聯融合組成的“二合一”重組蛋白疫苗,擬主要用於預防猴痘病毒感染。猴痘是一種由猴痘病毒感染所致的人獸共患病毒性疾病,猴痘病毒歸類於痘病毒科正痘病毒屬,痘科病毒複製過程中,產生兩種形態不同的病毒粒子:胞外囊膜病毒和胞內成熟病毒,且都有感染性。JT118既保留了抗原A35和M1兩種天然抗原的表位結構,又通過多抗原融合大幅增加了分子量,更有利於免疫激發。臨牀前研究結果表明,JT118在大小動物上接種均可以產生高水平的結合抗體、痘苗病毒/猴痘病毒中和抗體和細胞免疫激活,對痘苗病毒/猴痘病毒感染的大小動物模型均具有顯著的保護作用,且安全性良好。
2023年10月,公司與北京大學、中國科學院微生物研究所、山西高等創新研究院、北京航空航天大學達成合作,共同開發猴痘重組蛋白疫苗。截至本公告披露日,國內尚無預防猴痘病毒感染疫苗獲批上市。
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