A Study of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 9MW3011 in Patients With Polycythemia Vera

Exclusion Criteria

• •1. The spleen is palpable at least 5 centimeters below the left costal margin upon palpation at baseline.
• •2. Heart failure, unstable angina pectoris, myocardial infarction, and other thrombotic diseases within the 6 months prior to screening.
• •3. Abnormal QTc interval of electrocardiogram within the 6 months prior to screening.
• •4. Uncontrolled hypertension prior to screening.
• •5. Any non-PV myeloproliferative neoplasms (MPN).
• •6. Blast cells and blast granulocytes in the peripheral blood within the 3 months prior to screening.
• •7. Hematological indicators do not meet the requirements at the time of screening.
• •8. Known positive for active hepatitis B, hepatitis C, syphilis or human immunodeficiency virus (HIV) infection.
• •9. History of invasive malignancies within the last 5 years.
• •10. Severe infection or uncontrolled active infection.
• •11. Other hematological and lymphatic system diseases or any diseases causing hemolysis or erythrocyte instability.
• •12. Other systemic diseases or a family history of systemic diseases, may affect the subject's safety or any other diseases and physiological conditions that may affect the results of the study, judged by the investigator.
• •13. Specific history of allergies.
• •14. Subjects who have used monoclonal antibodies within the 6 months prior to screening.
• •15. Patients who have received vaccinations within 6 weeks prior to screening.
• •16. Subjects who have received other antitumor therapeutic drugs for PV prior to screening.
• •17. Chronic diseases requiring treatment with systemic glucocorticoids or other immunosuppressants.
• •18. History of drug abuse or illicit drug use within 3 months prior to screening.
• •19. Participation in other clinical trials within 3 months prior to screening.
• •20. Planned elective surgery during the study.
• •21. History of surgery within 3 months prior to screening.
• •22. Intolerable iron deficiency-related symptoms judged by the investigator prior to the first dosing.
• •23. Pregnant or lactating females; women of reproductive age who are not using effective contraception.
• •24. Individuals directly associated with the research and/or their immediate family members.
• •25. Other factors which may potentially affect the assessment of the study results by the investigator.