The main purpose of this study is to evaluate the efficacy of MY008211A in PNH patients with residual anemia despite treatment with anti-C5 antibody.
Male and female participants ≥ 18 years of age and BMI ≥ 18.0 kg/m2 with a diagnosis of PNH confirmed by high-sensitivity flow cytometry with clone size ≥ 10%.
Stable regimen of anti-C5 antibody treatment for at least 6 months before treatment, and Hb was still < 100 g/L.
The average hemoglobin level of at least two tests in 4 months before screening < 100 g/L.
The average hemoglobin level of two tests in the central laboratory during screening < 100 g/L.
Patients with reticulocytes <100x10^9/L; platelets <30x10^9/L; neutrophils <0.5x10^9/L.
History of recurrent invasive infections caused by encapsulated organisms,e.g. meningococcus or pneumococcus.
Known or suspected hereditary complement deficiency.
Previous bone marrow or hematopoietic stem cell transplantation.