荃信生物子公司乌司奴单抗注射液适应症获批

财中社
Mar 03

  3月3日,荃信生物-B(02509)发布公告,2025年3月3日,公司宣布其子公司与中美华东合作的药物QX001S(赛乐信®,乌司奴单抗注射液)获得国家药品监督管理局的批准,新增适应症为儿童斑块状银屑病。这一适应症的批准主要是针对6岁及以上儿童和青少年(体重60公斤至100公斤)中重度斑块状银屑病患者,药物的注册分类为治疗用生物制品3.3类。

  根据公告内容,QX001S的研发与注册情况显示,该药物是原研产品Stelara®(喜达诺®,乌司奴单抗注射液)的生物类似药,具有阻断IL-12和IL-23介导的信号传导的作用。全球范围内,Stelara®在2024年的销售额达到103.61亿美元(约752.21亿元人民币),而在中国市场,2023年及2024年上半年该药物的销售额分别为13.22亿元人民币和7.39亿元人民币。

(文章来源:财中社)

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