I-Mab and HI-Bio have received breakthrough therapy designation from the US Food and Drug Administration (FDA) for the investigational CD38 antibody, felzartamab, to treat primary membranous nephropathy (PMN).

PMN is a rare autoimmune kidney disease and is a major contributor to nephrotic syndrome among adults globally.

Felzartamab received the designation based on clinical data from the open-label Phase Ib/IIa proof-of-concept study, M-PLACE.

In November 2017, MorphoSys and I-Mab signed a licensing agreement for felzartamab.

The agreement provided I-Mab full rights for the development and commercialisation of the therapy across Greater China: mainland China, Hong Kong, Taiwan and Macau.

In June 2022, HI-Bio in-licensed felzartamab from MorphoSys and now holds exclusive global rights, except for Greater China.

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I-Mab is assessing felzartamab for both autoimmune and oncology diseases.

It is carrying out a Phase III registration trial for felzartamab in conjunction with lenalidomide and dexamethasone as a second-line multiple myeloma (MM) therapy in China.

The primary endpoint of the trial is progression-free survival.

The data read-out is expected in 2024, followed by a planned submission for a biologics licence application (BLA).

I-Mab president Dr Andrew Zhu stated: “We are excited about the potential therapeutic benefit of felzartamab through this breakthrough therapy designation by the FDA, following the orphan drug designation received in May.

“This designation represents an important milestone for I-Mab, our partner HI-Bio, and the PMN community as we continue to evaluate felzartamab as an innovative immunotherapy for multiple indications, including cancers and autoimmune diseases.”