Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)

Exclusion Criteria

• •1. Any previous treatment with anti-CD20, eculizumab, anti-BLyS monoclonal antibody (e.g., belimumab), any other treatment for prevention of multiple sclerosis (MS) relapse (e.g., interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) within 6 months prior to baseline.
• •2. Received immunosuppression such as azathioprine, mycophenolate mofetil, methotrexate, cyclophosphamide, tacrolimus, mitoxantrone, cyclosporine A, etc, and rug therapy, biological agents such as satralizumab, tocilizumab, eculizumab, etc, 3 months prior to the first administration.
• •3. Evidence of serious uncontrolled concomitant diseases that may preclude participant participation, as described; Other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency.
• •4. Known active infection within 3 months prior to baseline
• •5. Pregnancy or lactation.
• •6. History of severe allergic reaction to a biologic agent
• •7. Evidence of chronic active hepatitis B or C
• •8. Evidence of active tuberculosis
• •9. Following laboratory abnormalities at screening\*:
• •1. White blood cells (WBC) \<4.0 x10\^3/microliter (μL)
• •2. Absolute neutrophil count (ANC)
• •3. Absolute lymphocyte count \<0.5 x10\^3/μL
• •4. Platelet count \<80 x 10\^9/ L
• •5. Aspartate aminotransferase (AST) or alanine aminotransferase
• •10. History of drug or alcohol abuse within 6 months prior to baseline
• •11. Receipt of any live or live attenuated vaccine within 4 weeks prior to baseline
• •12. Uncontrolled systemic diseases, including hypertension that cannot be effectively controlled after treatment (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg), diabetes, gastrointestinal diseases, etc.; or the investigator believes that there is anything inappropriate reasons for selection.