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# I-Mab Gets Breakthrough for Nephropathy
- URL: https://www.fdaweb.com/i-mab-gets-breakthrough-for-nephropathy/
- Published: 2023-11-02T12:00:00.000Z
- Updated: 2026-09-14T14:15:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155714

FDA has granted I-Mab a breakthrough therapy designation for felzartamab, an investigational CD38 antibody for treating primary membranous nephropathy (PMN). The designation was based on clinical data from the M-PLACE Phase 1b/2a proof-of-concept, open-label study, according to the company.

“We believe that the cellular depletion strategy with felzartamab in PMN is applicable to many more immune-mediated diseases driven by antibodies produced in CD38+ plasma cells,” I-Mab says. “For that reason, we are currently developing felzartamab in multiple diseases including PMN, IgA nephropathy, antibody-mediated rejection and lupus nephritis.”

I-Mab says it is also currently conducting a Phase 3 registrational study of felzartamab in combination with lenalidomide and dexamethasone as a second-line treatment for multiple myeloma in China with progression-free survival as the primary endpoint. A data read-out is expected in 2024, followed by a planned BLA submission, it adds.

PMN is a rare autoantibody-mediated autoimmune kidney disease and a leading cause of nephrotic syndrome in adults worldwide, according to the company. It is characterized by a “thickening of the glomerular basement membrane due to the formation and deposition of immune complexes in this space between podocytes and the glomerular endothelium of the kidney,” it says, adding that about 80% of PMN cases occur due to autoantibodies that recognize the phospholipase A2 receptor antigen expressed on podocytes.