A Multicenter, Randomized, Open-Label, Positive Controlled Phase III Study to Evaluate the Efficacy and Safety of VSA012 Injection in Participants With Paroxysmal Nocturnal Hemoglobinuria Who Are Naive to Complement Inhibitor Therapy

A Multicenter, Randomized, Open-Label, Positive Controlled Phase III Study to Evaluate the Efficacy and Safety of VSA012 Injection in Participants With Paroxysmal Nocturnal Hemoglobinuria Who Are Naive to Complement Inhibitor Therapy

A study of the efficacy and safety of VSA012 Injection compared to eculizumab for 24 weeks in patients with PNH.

Inclusion Criteria:

• 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%.
• Mean hemoglobin level <100 g/L at screening.
• LDH > 1.5 x Upper Limit of Normal (ULN) at screening.
• Vaccination against Neisseria meningitidis infection is required prior to the
• start of study treatment. If not received previously, vaccination against
• Streptococcus pneumoniae and Haemophilus influenzae infections should be given.

Exclusion Criteria:

• Known or suspected hereditary or acquired complement deficiency;
• Presence or suspicion of a systemic active bacterial, viral, or fungal infection
• History of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.)
• Patients with reticulocytes <100x10^9/L; platelets <30x10^9/L; neutrophils <0.5x10^9/L.
• Positive of HIV, HBsAg or HCVAb.
• History of recurrent invasive infections caused by encapsulated organisms,e.g. meningococcus or pneumococcus.
• Previous splenectomy.
• A history of malignancy within 5 years before screening