君实生物-B(01877.HK)重组人源化抗IL-17A单克隆抗体注射液获准进行临床试验
格隆汇8月27日丨君实生物-B(01877.HK)公布,近日,公司及其子公司苏州君盟生物医药科技有限公司、上海君实生物工程有限公司、苏州众合生物医药科技有限公司收到国家药品监督管理局核准签发的重组人源化抗IL-17A单克隆抗体注射液的《药物临床试验通知书》。
2019年6月20日,公司、苏州君盟生物医药科技有限公司、上海君实生物工程有限公司、苏州众合生物医药科技有限公司向国家药监局递交临床试验申请并获得受理;近日,公司收到国家药监局核发的临床试验通知书,同意该药物进行临床试验。截至2019年7月31日,公司在该药品研发项目已直接投入约5,065万元人民币。
IL(白细胞介素)-17A是一种具有多效性的细胞因子,其分泌失调与自身免疫性疾病如银屑并类风湿性关节炎、强直性脊柱炎等疾病的发生发展密切相关。重组人源化抗 IL-17A单克隆抗体通过与IL-17A高亲和力结合并选择性地阻断IL-17A与其受体IL-17RA/IL-17RC的结合,从而阻断下游信号通路的激活和炎性因子的释放,缓解疾病症状。
目前,国外已获批上市具有相同靶点的单抗产品包括可善挺(Secukinumab,诺华)、Taltz(Ixekizumab,礼来)和Siliq(Brodalumab,Valeant),其中诺华的可善挺已于国内上市。
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