君实生物(688180.SH):偌考奇拜单抗注射液新药上市申请获得受理

智通财经
Dec 05, 2025

智通财经APP讯,君实生物(688180.SH)发布公告,近日,公司收到国家药品监督管理局核准签发的《受理通知书》,公司产品偌考奇拜单抗注射液(重组人源化抗IL-17A单克隆抗体注射液,产品代号:JS005)用于治疗适合系统治疗或光疗的中度至重度斑块状银屑病的成人患者的新药上市申请获得受理。

偌考奇拜单抗是公司自主研发的特异性抗IL-17A单克隆抗体。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病、类风湿关节炎、强直性脊柱炎等疾病的发生发展密切相关。偌考奇拜单抗通过与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,能有效地缓解自身免疫性疾病的症状。截至公告披露日,除本次新药上市申请外,偌考奇拜单抗用于治疗活动性强直性脊柱炎的Ⅱ期临床研究的所有参与者已完成治疗,进入安全随访期。

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