A Phase III Study to Evaluate the Efficacy and Safety of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Are Naive to Complement Inhibitor Therapy

Inclusion criteria

• Age ≥ 18 and ≤ 75 years, Male and female patients;
• Diagnosis of PNH based on flow cytometry with clone size > 10% by granulocytes;
• Have not received complement inhibitor treatment;
• Blood LDH values > 1.5 ×upper limit of the normal range (ULN) ;
• Hemoglobin level < 10 g/dL at screening.

Exclusion criteria

• Hereditary or acquired complement deficiency;
• Active primary or secondary immunodeficiency;
• History of splenectomy, bone marrow/ hematopoietic stem cell or solid organ transplants;
• History of recurrent invasive infections caused by encapsulated organisms( e.g. meningococcus or pneumococcus) or Mycobacterium tuberculosis;
• Patients with laboratory evidence of bone marrow failure (reticulocytes < 100x10^9/L, or platelets < 30x10^9/L or neutrophils < 0.5x10^9/L) ;
• Active systemic infection within 2 weeks prior to study drug administration;
• History of serious comorbidities that have been determined to be unsuitable for participation in the study.
• Pregnant or Lactating women.