华东医药(000963.SZ)：赛乐信®和赛捷宁®克罗恩病适应症获批上市

智通财经05-21

智通财经APP讯，华东医药(000963.SZ)发布公告，近日，公司全资子公司杭州中美华东制药有限公司(以下简称“中美华东”)收到国家药品监督管理局(NMPA)核准签发的《药品注册证书》及《药品补充申请批准通知书》，由中美华东申报的乌司奴单抗注射液(静脉输注)(商品名：赛捷宁®)和乌司奴单抗注射液(商品名：赛乐信®)(研发代码：HDM3001-2/QX001S)用于克罗恩病的上市许可申请和补充申请获得批准。

公司赛乐信®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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