Shanghai Meiye Biotechnology Co., Ltd.

Primary objective: To observe the pharmacokinetic characteristics of a single intravenous injection of 12 μg/kg of rhEPO-Fc for injection in healthy Chinese male subjects before and after the change of origin, and to evaluate the bioequivalence of the three preparations under fasting conditions. Secondary objective: To observe the pharmacodynamic characteristics, immunogenicity, and safety of a single intravenous injection of 12 μg/kg of rhEPO-Fc for injection in healthy Chinese male subjects before and after the change of origin. Exploratory objective: To explore the pharmacokinetic characteristics of rhEPO-Fc and EPO within 24 hours after a single intravenous injection of 12 μg/kg of rhEPO-Fc for injection in healthy Chinese male subjects.

By comparing rhEPO-Fc with the positive drug Levitra, the efficacy and safety of rhEPO-Fc for maintenance treatment of anemia in Chinese chronic kidney disease patients undergoing hemodialysis were investigated.

To explore the safety and efficacy of rhEPO-Fc in Chinese subjects with renal anemia after using different doses of rhEPO-Fc, different dosing intervals, and for 12 consecutive weeks; to provide a basis for the next stage of clinical research.