荃信生物-B(02509.HK):QX001S(烏司奴單抗注射液)用於克羅恩病的上市許可申請和補充申請獲得受理
格隆匯2月12日丨荃信生物-B(02509.HK)發佈公告,於2025年2月11日,烏司奴單抗注射液(靜脈輸注)和烏司奴單抗注射液(研發代碼:QX001S/HDM3001-2)用於克羅恩病的上市許可申請和補充申請獲得受理。
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。
此次獲得烏司奴單抗克羅恩病適應症上市許可申請和補充申請受理通知書,是該款藥品研發進程中的又一重要進展,對公司當期業績不會產生重大影響,長期有利於提升產品覆蓋人羣,進一步提升公司在自身免疫領域的核心競爭力。
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