A Clinical Study on the Efficacy and Safety of HBM9161 in Patients With ITP

Exclusion Criteria

• •1. Other autoimmune systemic diseases other than ITP.
• •2. Multi-lineage immune cytopenias, such as Evan's syndrome, autoimmune pancytopenia.
• •3. Secondary ITP.
• •4. Received a vaccine within 4 weeks prior to the first dose of the study drug or planned during the study.
• •5. Use of anticoagulants or any agents that have antiplatelet effect or can affect thrombopoiesis within 3 weeks prior to the first dose of the study drug.
• •6. Received blood transfusion within 1 week prior to the first dose of the study drug.
• •7. Received the intravenous gamma globulin, anti-D immunoglobulin, or plasmapheresis within 2 weeks prior to the first dose of the study drug.
• •8. Received high-dose dexamethasone or high-dose methylprednisolone within 2 weeks prior to the first dose of the study drug.
• •9. Received recombinant human thrombopoietin (rhTPO) within 4 weeks prior to the first does of the study drug.
• •10. Received rituximab or other non-rituximab anti-CD20 drugs within 6 months prior to the first does of the study drug.
• •11. Treated with splenectomy within 4 weeks prior to first dose of the study drug.
• •12. Any thromboembolic or embolic events within 12 months prior to the first does of the study drug.
• •13. Serum total IgG \< 700 mg/dL at the screening visit.