康诺亚：重点研发产品CM512拿下突破性治疗认定

财中社07-23 14:46

　　7月23日，康诺亚（02162）发布公告，公司重点研发产品CM512（TSLP/IL-13双抗）已被国家药品监督管理局药品审评中心纳入突破性治疗品种名单，用于治疗慢性鼻窦炎伴鼻息肉。

　　CM512是公司自主研发的一种重组抗胸腺基质淋巴细胞生成素（TSLP）和抗白介素-13 （IL-13）双特异性抗体，为全球首款IgG-like长效型TSLPxIL-13双阻断剂。

　　公告提到，突破性疗法认定是一种旨在加速治疗严重或危及生命疾病的新药研发与审评的特殊认定程序。其核心是让在早期临床试验中展现出显著疗效优势的药物，能获得药监部门更密切的指导与更快的审评通道，从而尽快惠及患者。

（文章来源：财中社）

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