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国家药监局批准用于罕见病治疗的奥法妥木单抗注射液上市

證券時報 ·  Dec 21, 2021 16:24
Securities Times Network News, according to news from the State Drug Administration on the 21st, recently, the China Drug Administration approved the import registration application for the rare disease drug ofatumumab injection (English name: Ofatumab Injection) through a priority review and approval procedure to treat recurrent multiple sclerosis (RMS) in adults, including clinically isolated syndrome, relapse-relieving multiple sclerosis, and active secondary progressive multiple sclerosis.
Multiple sclerosis (MS) is an immune-mediated chronic central nervous system disease and has been included in the first batch of rare diseases in China. Ofatumab injection is an all-human immunoglobulin G1 monoclonal antibody against CD20. It targets CD20 molecules and achieves therapeutic effects by inducing B-cell lysis. The marketing of this variety provides patients with treatment options.

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