MSC303 Subcutaneous Injection for the Treatment of Immunologic Glomerular Disease.

The primary endpoint of Phase Ib：Evaluate the safety of MSC303 in patients with Lupus Nephritis (LN）and ANCA-associated glomerulonephritis (ANCA-GN).

The primary endpoint of Phase II：Evaluate the change of Urine Protein/Creatinine Ratio (UPCR) in Week 12 compared with the baseline of MSC303 in patients with Lupus Nephritis(LN） and ANCA-associated glomerulonephritis (ANCA-GN).

Inclusion criteria

• Aged 18 to 65 years (including boundary values), gender unspecified；
• Willing to participate voluntarily in this clinical study and with good compliance；
• Regarding the criteria for the study diseases, meet the diagnostic criteria for any of the following diseases:

• Diagnosed with lupus nephritis(LN);
• diagnosed with ANCA-associated glomerulonephritis (ANCA-GN);
• Sufficient organ function;

Exclusion criteria

• History of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of MSC303；
• Active infection requiring antibiotic treatment；
• Concomitant with other serious diseases；
• Patients with congenital immunoglobulin deficiency；
• Infection with human immunodeficiency virus (Human immunodeficiency virus (HIV)), hepatitis B or hepatitis C (including HBsAg, HBcAb positive with abnormal Hepatitis B Virus DNA (HBV DNA) or Hepatitis C virus RNA (HCV RNA ));
• Other exclusion criteria may apply.