China-based I-Mab (NASDAQ: IMAB) and its US partner HI-Bio have announced that they have received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for their CD38 monoclonal antibody (mAb), felzartamab. This designation highlights the drug’s potential as a treatment for primary membranous nephropathy (PMN), a rare kidney disease.
Background on Licensing Deals
I-Mab secured exclusive development and commercialization rights to felzartamab in Greater China through a licensing deal with MorphoSys in November 2017. Subsequently, HI-Bio entered into an equity investment and licensing agreement with MorphoSys in June 2022, which granted HI-Bio global rights and commercialization rights to the drug outside of Greater China.
Clinical Studies and Applications
I-Mab is currently conducting studies for felzartamab in both cancer and autoimmune diseases. This includes a Phase III regulatory study for the drug in combination with lenalidomide and dexamethasone for the treatment of second-line multiple myeloma (MM). The results of this study are anticipated in the coming year, offering the potential for significant advancements in the treatment of MM.-Fineline Info & Tech
