Clinical Research Directory

Inclusion Criteria: * Male or female, aged 18 to 65 years. * Diagnosis of PNH based on flow cytometry with clone size \> 10% by granulocytes. * Presence of one or more PNH-related signs or symptoms within 3 months prior to screening or a history of transfusion due to PNH. * LDH level ≥2.0×upper limit of the normal range(ULN). * Hemoglobin level \<100 g/L at screening. Exclusion Criteria: * Active or suspected active viral, bacterial, fungal, or parasitic infection within 14 days prior to screening. * History of meningococcal infection. * History of splenectomy or congenital asplenia. * History of systemic autoimmune disease or known/suspected immunodeficiency. * History of hematopoietic stem cell transplantation. * Use of any complement inhibitor within 3 months prior to screening or within 5 drug half-lives (whichever is longer). * Pregnant or breastfeeding women, or women planning to become pregnant during the study or follow-up period.