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華東醫藥(000963.SZ):獲得烏司奴單抗注射液兒童斑塊狀銀屑病適應症補充申請批準通知書
格隆匯 03-03 17:22

格隆匯3月3日丨華東醫藥(000963.SZ)公佈,2025年3月3日,華東醫藥股份有限公司全資子公司杭州中美華東製藥有限公司(簡稱“中美華東”)收到國家藥品監督管理局(NMPA)覈準簽發的《藥品補充申請批準通知書》,由中美華東申報的烏司奴單抗注射液(商品名稱:賽樂信®,研發代碼:HDM3001/QX001S)新增兒童斑塊狀銀屑病適應症的補充申請獲得批準。

HDM3001(QX001S)是原研產品Stelara®(喜達諾®,烏司奴單抗注射液)的生物類似藥,作用機理爲阻斷IL-12和IL-23共有的p40亞基與靶細胞表面的IL-12Rβ1受體蛋白的結合,從而抑制IL-12和IL23介導的信號傳導和細胞因子級聯反應。IL-12和IL-23是兩種天然存在的細胞因子,在免疫介導的炎症性疾病中發揮着關鍵作用。

截至目前,公司在HDM3001(QX001S)項目的研發直接投入總金額約爲15,860萬元。

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