A Clinical Trial of BAT4406F Injection in Patients with Neuromyelitis Optica Spectrum Disorders

Inclusion Criteria:

1. Age greater than or equal to the age of 18 and less than or equal to 65 patients,gender not limited;

2. Met the 2015 international NMO diagnostic panel (IPND) criteria for NMOSD, AndAQP4-IGG positive patients

3. Screening before 2 times at least 2 years experience with clinical records ofrelapse，or experienced at least 1 clinically documented recurrence within 1 yearprior to screening

4. For subjects who had a relapse before screening, symptoms needed to be stable for atleast 4 weeks before randomization

5. Into the group of former dosage of corticosteroids under 30 mg and prednisoneequivalent，and the trial drug must be used within a month after the withdrawal ofhormones

6. The score of EDSS 7 or less

7. Has the fertility of men and women must agree during treatment and 6 months afterthe last dose of using effective birth control method;

8. Agreed to participate in trials, and books to sign the informed consent

Exclusion Criteria:

1. CD19 + b-cell count below the lower limit of normal, b-cell-scavenger drugs used 6months before baseline or within 5 half-lives of the drug, whichever is older (including but not limited to Rituximab, enalizumab, etc.) ;

2. 6 months prior to the baseline used other monoclonal antibody therapy;Baseline usedwithin five half-life before other biological preparation;

3. Used it for 3 months prior to the baseline McCaw phenol ester, azathioprine andmethotrexate;6 months prior to the baseline using cyclophosphamide;Baseline beforefive half-life

4. Within a month before the filter used intravenous immunoglobulin (IVIG), plasmaexchange (PE);

5. Within 4 weeks before screening received vaccine or live attenuated;Within 2 weeksbefore the baseline received inactivated vaccine;Baseline received within 4 weeksbefore the new coronavirus vaccine

6. In another clinical study and the baseline from the test drug treatment under threemonths or 5 half-life of the drug (the long time limit shall prevail);

7. This test for monoclonal antibody has a history of allergies, known in drug allergypatients;Serious drug allergy or for two or over two kinds of food or drugs；

8. 6 months prior to screening, except NMOSD need continuous oral or intravenousglucocorticoid dose > 20 mg/day of any more than 21 days

9. Abnormal liver, kidney and bone marrow reserve

10. HIV positive at HIV history or enrollment screening; History of hepatitis B Andorhepatitis C or Hepatitis B surface antigen (HBSAG) positivity at screening [ orHepatitis B core antibody positive, hepatitis B surface antibody negative, HepatitisB virus deoxynucleotides (HBV DNA) quantification exceeding normal range ] ; OrHepatitis C virus (HCV) antibody positive [ with HCV-rna quantitation exceeding thenormal range ] , Treponema pallidum antibody positive at the time of enrollment;

11. Comply with any of the following subjects a latent or active TB infection relatedstandards:

12. Current or past people with active TB;

13. In history and/or physical examination during filter tip physical signs orsymptoms of active TB;

14. Recent close contact with people with active TB;

15. At the time of screening, the positive result of TB infected T cells was found.A test could be repeated if the subject's first tb-infected t-cell test resultwas inconclusive, and the patient was excluded from this study if the testresult was inconclusive (or positive) again.

16. Covid-19 infection was diagnosed with clinical symptoms or signs consistent with 2019 coronavirus (COVID-19) infection (eg, fever, dry cough, dyspnea, sore throat,and fatigue) within 4 weeks before screening or during screening, or uponappropriate laboratory testing (at the discretion of the investigator or inaccordance with local regulations) . If COVID-19 infection is confirmed beforescreening, appropriate laboratory testing is required to confirm that the infectionhas been cured;

17. Suffering from metabolic, hematological, renal, hepatic, pulmonary, neuroendocrine,cardiac, infectious, gastrointestinal or other autoimmune diseases, the researchersbelieve there is an unacceptable risk to patients, or it may affect NMOSDassessment;

18. According to the researchers, there was a history of drug and alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL ofspirits, or 125 mL of wine) in the 12 months before screening；

19. Subjects who are unable to undergo an MRI scan (for example, are allergic toGd-containing MRI contrast media, have a pacemaker, defibrillator, or other metallicobject with internal or external limitations to performing an MRI scan) ;

20. Pregnant or lactating women, and screening or baseline pregnancy test positivefemale subjects;

21. Researchers think that the other does not fit to participate in this study.