Johnson & Johnson's (JNJ.US) NicaRliMonoclonal Injection is planned to be included in priority review.

On November 12, the CDE official website announced that Johnson & Johnson's Nipocalimab injection is planned to be included in priority review, suitable for treating adult and adolescent (ages over 12) patients with generalized myasthenia gravis (gMG) who are positive for autoantibodies. Nipocalimab is a investigational FcRn antibody acquired by Johnson & Johnson through the approximately $6.5 billion acquisition of Momenta Pharmaceuticals. In August of this year, the drug has already been filed for approval in the United States for the treatment of myasthenia gravis. Being included in the priority review by the CDE this time means that the drug may soon be approved for sale in China. Myasthenia gravis (MG) is an autoimmune antibody disease. The initial manifestation of MG is usually in the eyes, but about 85% of patients will develop symptoms beyond eye muscles, leading to generalized myasthenia gravis (gMG). In China, gMG has been included in the "First Batch of Rare Disease Catalog". In October of this year, Johnson & Johnson also announced positive results from the phase II/III Vibrance-MG study of Nipocalimab for the treatment of AChR-positive adolescents (ages 12-17). Johnson & Johnson's press release pointed out that this is the first FcRn inhibitor to demonstrate sustained disease control for 24 weeks in adolescents aged 12-17 who are positive for autoantibodies, expanding the study population for Nipocalimab.