智通财经APP讯，康哲药业(00867)公布，肾性贫血新药德昔度司他片(原名：德度司他片)上市许可申请已于2026年3月13日获得中国国家药品监督管理局(NMPA)批准。产品为一种创新型口服低氧诱导因子-脯氨酰羟化酶抑制剂(HIF-PHI)，适用于非透析的成人慢性肾臓病(CKD)患者的贫血治疗。
CKD患者肾功能逐渐丧失，最终出现肾衰竭。健康的肾脏会自然分泌促红细胞生成素 (EPO) ，这种激素可促进红细胞生成。如果肾功能受损，肾脏生成EPO水平下降或完全不生成EPO，从而导致贫血。HIF-PHI通过增加内源性促红细胞生成素的生成、改善铁的利用率和降低铁调素的水平来促进红细胞生成。产品中国III期临床试验取得了积极结果。主要研究终点血红蛋白(Hb)水平(第7-9周Hb平均值相对于基线的变化)结果显示，试验组优于安慰剂组。扩展期研究结果显示，产品可使Hb水平长期维持在达标水平，且安全性良好。此外，产品还可以显著降低铁调素水平，纠正铁代谢紊乱。
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