A Study of the Efficacy and Safety of FXS6837 Capsules Compared to Eculizumab for 24 Weeks in Patients With PNH.

Exclusion criteria

• . With laboratory evidence of bone marrow failure during screening (reticulocyte count \< 100 × 109/L, or platelet count \< 30 × 109/L, or neutrophil count \< 0.5 × 109/L); Received acute treatment (such as platelet transfusion, granulocyte colony-stimulating factor) for thrombocytopenia or neutropenia within 30 days before screening;
• . Participants receiving other therapies before screening that have not reached the following stable treatment durations:
• . History of malignant tumors of any organ or system within 5 years before screening (except local basal cell carcinoma of the skin or carcinoma in situ of the cervix), regardless of whether treatment was received and whether there is evidence of local recurrence or metastasis;
• . History of bone marrow/hematopoietic stem cell or solid organ transplantation (such as heart, lung, kidney, liver);
• . History of splenectomy or planned surgery during the study period;
• . Subjects with significantly abnormal liver function at screening: any parameter of alanine aminotransferase (ALT), γ-glutamyl transpeptidase (GGT), or alkaline phosphatase (ALP) \> 3 × ULN;
• . Human immunodeficiency virus (HIV) infection (HIV antibody positive), active syphilis infection, hepatitis B virus infection (hepatitis B surface antigen positive), active hepatitis C virus infection, or active tuberculosis infection at screening;
• . Subjects with concurrent systemic major diseases, including but not limited to: advanced heart disease (such as New York Heart Association \[NYHA\] class IV), severe lung disease (such as severe pulmonary hypertension \[WHO class IV\]), active hepatitis, severe kidney disease (estimated glomerular filtration rate eGFR \< 30 mL/min/1.73 m2 or chronic kidney disease \[CKD\] stage 4 or dialysis patients), unstable thrombosis, active gastrointestinal bleeding, other hematologic diseases (such as chronic anemia unrelated to PNH), and deemed unsuitable for study participation by the investigator;