Shanghai Meiyue Biotech Development Co. Ltd.

To evaluate the pharmacokinetic (PK) characteristics of MY008211A tablets in subjects with normal renal function, moderate and severe renal impairment; to evaluate the safety of MY008211A tablets in subjects with normal renal function, moderate and severe renal impairment.

Primary objective To evaluate the long-term safety and tolerability of MY008211A tablets in the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH). Secondary objective To evaluate the long-term efficacy of MY008211A tablets in the treatment of patients with PNH.

Primary objective: To evaluate the efficacy of MY008211A tablets in the treatment of subjects with paroxysmal nocturnal hemoglobinuria on Day (D) 84, using the proportion of subjects whose hemoglobin (Hb) concentration increased by ≥20 g/L compared with baseline in subjects who did not receive red blood cell transfusion after 4 weeks of dosing. Secondary objective: To evaluate the safety and efficacy of MY008211A tablets in subjects with paroxysmal nocturnal hemoglobinuria. Exploratory objective: To explore the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of MY008211A tablets in subjects with paroxysmal nocturnal hemoglobinuria.