Core Viewpoint - Shenzhen Xinlitai Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the drug Enarodustat (恩那度司他片) to treat anemia in chronic kidney disease (CKD) patients undergoing dialysis, marking a significant expansion of its therapeutic applications [1][2]. Group 1: Drug Information - The drug Enarodustat is a new generation hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) approved for treating anemia in both dialysis and non-dialysis adult CKD patients [2]. - Enarodustat is available in tablet form with specifications of 1mg, 2mg, and 4mg, and is classified as a chemical drug of category 3 [1][2]. - The drug's approval number includes National Drug Approval Codes H20233662, H20233663, and H20233664 [1]. Group 2: Clinical Significance - Anemia is a common complication in CKD patients, significantly affecting their quality of life and increasing the risk of cardiovascular events and mortality [2]. - Enarodustat selectively targets the PHD1 enzyme, promoting endogenous EPO production closer to physiological levels, thereby improving iron metabolism and effectively increasing hemoglobin (Hb) levels with a high achievement rate and low thrombosis risk [2]. - The drug offers advantages such as once-daily oral administration, good adherence, no need for weight adjustment, and low risk of drug interactions [2]. Group 3: Future Prospects - The approval of the new indication for Enarodustat is expected to positively impact the company's future performance and long-term development [3]. - The company is also conducting clinical research for other indications of Enarodustat, including treatment for chemotherapy-induced anemia in non-myeloid malignancy patients, currently in various stages of clinical trials [2].

人民财讯9月5日电，信立泰（002294）9月5日晚间公告，近日，公司收到国家药监局核准签发的恩那度 司他片(恩那罗)药品注册证书，其用于治疗透析(包括血液透析和腹膜透析)慢性肾脏病(CKD)患者的贫 血适应症获批。 恩那罗是国内上市的新一代缺氧诱导因子脯氨酰羟化酶抑制剂(HIF-PHI)药物，2023年已获批用于非透 析的成人慢性肾脏病(CKD)患者的贫血治疗，并于同年被纳入国家医保目录；此次获批的适应症为治疗 透析CKD患者的贫血(统称"肾性贫血")。 ...