Proof of Concept Study to Assess the Efficacy, Safety of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria

Inclusion Criteria:

1. Diagnosis of PNH confirmed by flow cytometry with clone size ≥ 10%.

2. Have not received complement inhibitor therapy ;

3. LDH > 1.5×ULN;

4. Hemoglobin level < 10 g/dL.

Exclusion Criteria:

1. Known or suspected hereditary or acquired complement deficiency;

2. Patients with laboratory evidence of bone marrow failure (reticulocytes <100x109/L;platelets <30x109/L; neutrophils <0.5x109/L);

3. Presence or suspicion of a systemic active bacterial, viral, or fungal infection (based on judgment of the investigator) within 2 weeks prior to the first dose ofHRS-5965;

4. History of infection with capsular bacteria (e.g., meningococcus, pneumococcus,etc.)

5. Positive of HIV, HBsAg or HCVAb.