Johnson & Johnson Submits NDA for FcRn Antibody Nipocalimab in China for Generalized Myasthenia Gravis

April 23,Johnson & Johnson's FcRn Antibody Nikalimab Injection Marketing Application Accepted by NMPA.

Nipocalimab is aAntibody Therapy Targeting Neonatal Fc Receptor (FcRn). The product has been submitted to the U.S. FDA for market approval, intended for the treatment of generalized myasthenia gravis (gMG), with a PDUFA date ofApril 29。

NipocalimabHas been shown in clinical trials to reduce immunoglobulin (IgG) levels, including pathogenic IgG, which is considered one of the root causes of autoimmune antibody diseases.

In November 2024, the therapy was included in the priority review by the CDE., applicable for the treatment of adult and adolescent (over 12 years old) patients with generalized myasthenia gravis (gMG) who are autoantibody-positive. gMG is a chronic rare autoimmune disease.

Previously, Johnson & Johnson had successively submitted a Marketing Authorization Application (MAA) for nicarelimab to the FDA and the European Medicines Agency (EMA), seeking approval for the gMG indication.

The company announced in January this year a pivotal Phase 3 clinical trial designed to evaluate the efficacy of Nicarelimab in adult patients with generalized Myasthenia Gravis (gMG) who are positive for a broad range of antibodies (anti-AChR, anti-MuSK, and anti-LRP4).Test results.Notably, this therapy was also listed by the industry media Evaluate as one of the top 10 potential blockbuster therapies expected to launch this year at the beginning of the year.One of.

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