Novartis Submits Ofatumumab Injection for Market Approval in China Targeting CD20

On November 5, Novartis' marketing application for ofatumumab injection in China was accepted by the Center for Drug Evaluation (CDE).

Ofatumumab is a CD20 monoclonal antibody that was initially approved by the FDA in October 2009 for the treatment of chronic lymphocytic leukemia, administered via high-dose intravenous infusion under the brand name Arzerra. Given the established key role of B cells in the pathogenesis of autoimmune diseases such as multiple sclerosis (MS), Novartis launched a novel development program to investigate the efficacy of ofatumumab in treating relapsing multiple sclerosis (RMS).

In August 2020, the FDA approved ofatumumab (brand name: Kesimpta) as a subcutaneous injection for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. This is the first B-cell therapy that can be self-administered at home once monthly via an auto-injector pen.

The PharmaGo database from MedPharma Cube shows that currently, the only CD20 monoclonal antibodies approved for marketing in China are Roche's rituximab and its biosimilars. Additionally, Roche's obinutuzumab and Sinocelltech's lipertotamab have submitted production applications.