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石藥集團(01093.HK):烏司奴單抗注射液生物製藥上市申請獲得受理
格隆匯 11-26 16:59

格隆匯11月26日丨石藥集團(01093.HK)發佈公吿,公司附屬公司石藥集團巨石生物製藥有限公司開發的烏司奴單抗注射液的生物製藥上市申請已獲中國國家藥品監督管理局正式受理。該產品是一種全人源IgG1κ單克隆抗體,為IL-12/IL-23p40抑制劑。烏司奴單抗與IL-12和IL-23的p40蛋白亞單位以高親和力特異性結合,阻斷IL-12和IL-23與細胞表面受體IL-12Rb1的相互作用,從而抑制IL-12和IL-23介導的信號傳導和細胞因子的級聯反應,進而抑制角質細胞的增生,發揮治療銀屑病藥效作用。

該產品按照治療用生物製品3.3類申報,適應症為成人和兒童斑塊狀銀屑病。本次申請主要是基於一項關鍵III期臨牀試驗,入組患者為對任一系統性治療(包括環孢素、甲氨喋呤(MTX)、PUVA(補骨脂素和紫外線A)、阿維A膠囊)不應答、有禁忌或無法耐受的中度至重度斑塊狀銀屑病成人患者。臨牀試驗結果顯示該產品與原研藥喜達諾?於治療中度至重度斑塊狀銀屑病受試者的有效性高度一致,且安全性良好。該產品治療斑塊狀銀屑病療效好,穩定期給藥間隔為每12周給藥一次,具有顯著的臨牀應用優勢。

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