Novartis' Subcutaneous CD20 Monoclonal Antibody Ofatumumab Approved in China for Relapsing Multiple Sclerosis

According to the latest announcement by the National Medical Products Administration (NMPA) of China, the import registration application for Ofatumumab Injection, a rare disease treatment drug submitted by Novartis, has been approved through the priority review and approval process. It is indicated for the treatment of adult relapsing multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple sclerosis.

Source: NMPA official website

Multiple Sclerosis (MS) is an immune-mediated chronic central nervous system disease that has been included in the first batch of China's rare disease catalog. Ofatumumab Injection is a fully human immunoglobulin G1 monoclonal antibody targeting the CD20 molecule, which exerts its therapeutic effect by inducing B-cell lysis.

This variety is administered once a month via subcutaneous injection, allowing patients to self-administer at home, providing a treatment option for patients.

Ocrelizumab is a novel fully human monoclonal antibody targeting CD20. The drug was first approved by the FDA in 2009 for the treatment of chronic lymphocytic leukemia (CLL) and is administered via intravenous infusion. According to public information, the drug was initially developed by GlaxoSmithKline (GSK) and Denmark's Genmab. Novartis acquired the relevant rights to the drug a few years ago. After years of clinical development by Novartis, in August 2021, the FDA approved a new indication for ocrelizumab: as a subcutaneous injection for the treatment of adult patients with relapsing multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

In 2020, Novartis submitted a new drug marketing application for Ocrelizumab in China and was granted priority review. It is indicated for the treatment of adult relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple sclerosis.

Editor: Liuli

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