BDB-001 Phase III Trial in ANCA-Associated Vasculitis

Inclusion Criteria: 1. 18 years old≤Age≤75 years old, male or female; 2. Diagnosis of granulomatosis with polyangiitis(GPA) or microscopic polyangiitis(MPA)； 3. Newly diagnosed or relapsed GPA or MPA that requires treatment with a full starting dose of prednisone plus cyclophosphamide/azathioprine or rituximab； 4. Positive test for anti-proteinase 3(PR3) or anti-myeloperoxidase (MPO)； 5. Estimated glomerular filtration rate ≥15 mL/minute/1.73 m\^2； 6. At least 1 major item, or at least 3 non-major items, or at least the 2 renal items on BVAS； Exclusion Criteria: 1. Active tuberculosis infection; 2. alveolar hemorrhage requiring pulmonary ventilation support； 3. Any other known multi-system autoimmune disease including eosinophilic granulomatosis with polyangiitis (Churg-Strauss), systemic lupus erythematosus, IgA vasculitis (Henoch-Schönlein), rheumatoid vasculitis,anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis； 4. HBsAg positive,or HBcAb positive and HBV-DNA positive； 5. Received CYC within 3 months before the first administration or Received rituximab(RTX) within 12 months before the first administration； 6. Received glucocorticoid shock therapy within 4 weeks before the first administration； 7. Received an oral daily dose of a GC of \> 10 mg prednisone-equivalent for more than 6 weeks continuously before the first administration； 8. Received a anti-tumor necrosis factor and other biological agents treatment within 12 weeks before the first administration； 9. Received Continuous dialysis treatment for 12 weeks or more before the first administration; Received Dialysis within 1 week before the first administration; 10. Received intravenous immunoglobulin (Ig) or plasma exchange within 4 weeks before the first administration; 11. Pregnant or lactating.