Haosen Pharmaceutical's Class 1 new drug Peihua Xihippocampal peptide injection has been declared and marketed

October 09, 2021

Recently, Jiangsu Hausen Pharmaceutical Group Co., Ltd. (hereinafter referred to as "Hausen Pharmaceutical" or the "Company") independently developed a Class 1 new drug Peihua Xihippocampal peptide injection formally submitted a new drug listing application to the State Drug Administration. The drug is intended to be used for the treatment of "dialysis patients who are receiving erythropoietin therapy due to anemia caused by chronic kidney disease (CKD)". It only needs to be administered once every four weeks. After approval, it will bring patients with renal anemia New treatment options.

Chronic kidney disease (CKD) is a global public health problem and one of the most common major chronic diseases in my country. Epidemiological data show that in China, the prevalence of CKD accounts for about 10.8% of the adult population, and the total number of patients is about 120 million, of which more than 50% of patients have anemia. Renal anemia is a common complication of CKD. The incidence of anemia in CKD stage 5 patients is as high as 90%. If renal anemia is not effectively treated for a long time, it will seriously affect the quality of life of CKD patients. Peihuaxi hippocampal peptide injection is a class 1 new drug independently developed by Hausen Pharmaceuticals, and it is a new long-acting polypeptide erythropoietin (EPO) receptor agonist. The results of a key phase III clinical study conducted in erythropoietin-treated CKD dialysis anemia patients showed that the Peihuaxi hippocampal peptide injection study reached the primary efficacy endpoint and showed superiority; in healthy subjects and patients with renal anemia It has good safety and tolerability; Peihuaxi hippocampal peptide injection does not increase the risk of cardiovascular events compared with Lixebao in CKD population, and has potential safety advantages. It is worth mentioning that the current renal anemia drugs commonly used in clinical treatment are mostly administered once a week. After Peihuaxi hippocampus injection is approved for marketing, it will extend the interval between patients' medication to once every four weeks, which greatly relieves The inconvenience caused by frequent injections of patients improves patient compliance.

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