Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Inclusion criteria

• Patients have fully understood the trial, have voluntarily agreed to participate in this clinical trial, and have signed a written Informed Consent Form (ICF).
• Patients who have completed the treatment of the Phase Ⅱ clinical study of LP-005 Injection and are assessed by the investigator as eligible for continued treatment with LP-005 Injection.
• Patients who have received Neisseria meningitidis vaccine and Streptococcus pneumoniae vaccine in accordance with the requirements of previous studies; if the vaccine protection period does not cover the treatment duration of this study, patients must agree to receive booster vaccination in a timely manner in accordance with the vaccine administration guidelines and the requirements of local vaccination institutions.
• Females and males of childbearing potential (including male subjects with female partners) must agree to use effective contraceptive measures from the start of the trial until 3 months after the end of the trial.

Exclusion criteria

• Patients who have not completed the treatment of the Phase II clinical trial (P10-LP005-02) of the study drug.
• Patients who have completed the Phase II treatment phase but are unwilling to continue receiving the study drug treatment.
• Patients for whom the investigator does not recommend the continued use of LP-005 Injection after comprehensive assessment.
• Patients who did not participate in the Phase II clinical trial (P10-LP005-02) of the study drug.