智通财经APP讯，荃信生物-B（02509）公布，于2025年2月11日，乌司奴单抗注射液（静脉输注）和乌司奴单抗注射液（研发代码：QX001S/HDM3001-2）用于克罗恩病的上市许可申请和补充申请获得受理。
QX001S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。
此次获得乌司奴单抗克罗恩病适应症上市许可申请和补充申请受理通知书，是该款药品研发进程中的又一重要进展，对公司当期业绩不会产生重大影响，长期有利于提升产品覆盖人群，进一步提升公司在自身免疫领域的核心竞争力。
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