I-Mab Announces China NMPA Approval For Phase 1b Trial Of Felzartamab In Systemic Lupus Erythematosus

SHANGHAI and GAITHERSBURG, Md., June 25, 2021 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application to initiate a phase 1b trial of felzartamab, a CD38 antibody, in patients with systemic lupus erythematosus (SLE) The phase 1b trial of felzartamab, also known as TJ202/MOR202, is a multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in patients with SLE in China. Felzartamab is a fully human and differentiated monoclonal antibody that targets dysregulated CD38-positive B cells responsible for the pathogenic inflammatory processes underlying SLE inducing immune-mediated tissue damage. As it selectively targets the pathogenic B cells involved in SLE, felzartamab is supposed to have a distinct advantage over conventional B-cell targeting therapies. Preclinical studies suggest that felzartamab has disease-modifying potential in the treatment of SLE. "SLE is a chronic and incurable auto-immune disease, which can cause multiple organ damages. The current treatment options are very limited," said Dr. Joan Shen, CEO of I-Mab. "Felzartamab has the potential to modify the underlying pathophysiology of this disease and may offer a unique treatment option in long-term clinical management of SLE if approved." I-Mab is also currently conducting two parallel registrational trials with felzartamab to aim for registration for the treatment of multiple myeloma in Greater China. Felzartamab originally derived from MorphoSys' HuCAL® antibody technology and MorphoSys is currently evaluating the safety and efficacy of felzartamab in patients with anti-PLA2R antibody-positive membranous nephropathy.

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