荃信生物-B(02509):QX001S(赛乐信®,乌司奴单抗注射液)用于儿童斑块状银屑病的补充申请获得批准

智通财经
03 Mar

智通财经APP讯,荃信生物-B(02509)发布公告,于2025年3月3日,中美华东收到国家药品监督管理局(NMPA)核准签发的《药品补充申请批准通知书》,QX001S新增儿童斑块状银屑病适应症的补充申请获得批准。

QX001S是原研产品Stelara®(喜达诺®,乌司奴单抗注射液)的生物类似药,作用机理为阻断IL-12和IL-23共有的p40亚基与靶细胞表面的IL-12Rβ1受体蛋白的结合,从而抑制IL-12和IL-23介导的信号传导和细胞因子级联反应。IL-12和IL-23是两种天然存在的细胞因子,在免疫介导的炎症性疾病中发挥着关键作用。

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