赛诺菲(SNY.US)和再生元(REGN.US)合作开发的IL-33单抗在中国再获批临床 针对慢性鼻窦炎
智通财经APP获悉，今日（1月15日），中国国家药监局药品审评中心（CDE）官网公示，由赛诺菲（Sanofi）(SNY.US)申报的1类新药itepekimab注射液获批临床，拟适用于治疗慢性鼻窦炎不伴鼻息肉（CRSsNP）患者。公开资料显示，这是一款靶向IL33的单克隆抗体，由赛诺菲与再生元（Regeneron）(REGN.US)合作开发。该产品此前已经在中国获得多项临床试验默示许可，适应症包括治疗非囊性纤维化支气管扩张症（NCFB）、中度至重度慢性阻塞性肺疾病（COPD）患者的添加维持治疗。
截图来源：CDE官网
白介素-33（IL-33）是一种作用广泛的IL-1家族细胞因子，在外伤、过敏原暴露或感染等外部因素触发后，会从应激或受损的屏障组织（包括内皮和上皮）中释放出来。在正常生理条件下，IL-33可启动保护性免疫反应，然而过量的IL-33释放或慢性信号传导也会驱动组织损伤性炎症。研究表明，IL-33活性失调可能与多种炎症性疾病和严重感染性疾病的病理有关。抗IL-33抗体的治疗潜力已在针对哮喘、特应性皮炎和食物过敏等多种疾病的研究中得到初步验证。
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