金吾财讯 | 云顶新耀(01952)宣布，耐赋康®(NEFECON®)已获中国国家药监局的完全批准，取消了对蛋白尿水平的限制，用于治疗具有疾病进展风险的原发性Ig A肾病（“Ig A肾病”）成人患者。此次完全批准意味着耐赋康®成为中国首个且唯一获得中国药监局完全批准的Ig A肾病对因治疗药物。此次获批是基于Nef Ig Ard III期临床研究的完整数据。NefIgArdIII期临床试验是一项随机、双盲、全球多中心研究，在接受RAS抑制剂优化支持治疗的原发性IgA肾病成人患者中评估了耐赋康®（16mg，每日一次）与安慰剂相比的疗效和安全性。IgA肾病是一种进行性慢性自身免疫性疾病。缺乏半乳糖的Ig A1被自体抗体辨识并产生含IgA1免疫复合物,当该复合物沉积在肾脏的肾小球系膜时就会攻击肾脏。这种在肾脏中的沉积可导致进行性肾脏损伤，并可能导致终末期肾病。
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.