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荃信生物-B(02509.HK):QX001S(賽樂信,烏司奴單抗注射液)用於兒童斑塊狀銀屑病的補充申請獲得批準
格隆匯 03-03 20:04

格隆匯3月3日丨荃信生物-B(02509.HK)公告,於2025年3月3日,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》,QX001S新增兒童斑塊狀銀屑病適應症的補充申請獲得批準。

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IL-23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。

此次QX001S新增適應症的獲批,不會對公司當前財務狀況和經營成果產生重大影響,未來該產品的銷售受到行業政策變化、市場需求及競爭狀況等多種因素的影響,對公司利潤影響有一定不確定性。公司將積極保障產品供給,全力支持該產品的商業化工作。

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