HIF - PHI药物
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信立泰(002294.SZ):恩那罗(恩那度司他片)新增适应症获得药品注册证书
Ge Long Hui A P P· 2025-09-05 11:34
Core Viewpoint - The approval of Enarodustat (恩那度司他片) by the National Medical Products Administration marks a significant advancement in the treatment of anemia in chronic kidney disease (CKD) patients undergoing dialysis, providing a new therapeutic option that addresses unmet clinical needs [1] Company Summary - Xintai (信立泰) has received the drug registration certificate for Enarodustat, a new generation HIF-PHI drug, which selectively targets PHD1 enzyme, leading to a more rational regulation of HIF targets [1] - The drug promotes the production of endogenous EPO (erythropoietin) closer to physiological concentrations, improving iron metabolism trends and effectively increasing hemoglobin (Hb) levels [1] Industry Summary - Enarodustat is characterized by high achievement rates, low exceedance rates in elevation speed, and reduced thrombotic risks, making it a safer option for patients [1] - The drug offers advantages such as once-daily oral administration, good medication adherence, no need for weight adjustment, and low risk of drug interactions [1] - The launch of this new indication will provide CKD patients with anemia a novel treatment choice, better meeting the clinical demands in this area [1]