智通财经APP讯，康诺亚-B(02162)发布公告，中国国家药品监督管理局(NMPA)已于近日批准司普奇拜单抗(抗IL-4Rα单克隆抗体，商品名：康悦达，研发代号： CM310)治疗慢性鼻窦炎伴鼻息肉的新适应症上市申请。
本次获批是基于一项多中心、随机、双盲、安慰剂对照的III期临床研究，主要用于确证司普奇拜单抗注射液在治疗慢性鼻窦炎伴鼻息肉患者中的有效性及安全性。研究结果显示本项III期临床试验数据结果积极。相较安慰剂，司普奇拜单抗治疗24周后能显著缩小鼻息肉(鼻息肉评分(NPS)较基线改善2.3)、缓解鼻塞(鼻塞评分(NCS)较基线改善0.7)，具有高度显著的统计学差异(P均<0.0001)。同时有效减轻鼻窦炎症、恢复嗅觉、改善鼻部综合症状，并提高生活质量。其亦显示出良好的安全性。
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