康诺亚(02162.HK)治疗慢性鼻窦炎伴鼻息肉药物新适应症上市申请获批

阿斯达克财经16:43

康诺亚(02162.HK) 公布，国家药监局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(sNDA)。

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。研究结果显示该项III期临床试验数据结果积极。(jl/u)(港股报价延迟最少十五分钟。沽空资料截至 2024-12-23 16:25。)

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