财中社12月23日电康诺亚-B(02162)发布自愿性公告,宣布中国国家药品监督管理局已批准司普奇拜单抗(商品名:康悦达)用于治疗慢性鼻窦炎伴鼻息肉的新适应症上市申请。该批准基于一项多中心、随机、双盲、安慰剂对照的III期临床研究,研究结果显示,司普奇拜单抗在治疗24周后,能够显著缩小鼻息肉,鼻息肉评分(NPS)较基线改善2.3,鼻塞评分(NCS)较基线改善0.7,且具有高度显著的统计学差异(P均<0.0001)。
司普奇拜单抗是一种针对白介素4受体α亚基的高效人源化抗体,是首个获得NMPA批准上市的IL-4Rα抗体药物。通过靶向IL-4Rα,能够双重阻断引发II型炎症的关键细胞因子IL-4和IL-13。该药物在多项临床试验中表现出良好的安全性和疗效,且已于2024年9月获批用于治疗成人中重度特应性皮炎。
(文章来源:财中社)
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