According to the Securities Times APP, on November 12th, the CDE official website announced that Johnson & Johnson (JNJ.US) Nipocalimab injection is planned to be included in priority review, suitable for treating adult and adolescent patients (over 12 years old) with generalized myasthenia gravis (gMG) who are positive for autoantibodies. Nipocalimab is an investigational FcRn antibody acquired by Johnson & Johnson through a approximately $6.5 billion acquisition of Momenta Pharmaceuticals. In August of this year, the drug was already filed for market approval in the United States for the treatment of myasthenia gravis. Being included in the planned priority review by CDE this time means that the drug is also expected to be marketed in China soon.

Myasthenia gravis (MG) is an autoimmune disease. The initial manifestation of MG usually involves the eyes, but about 85% of patients will develop symptoms beyond the eye muscles, progressing to generalized myasthenia gravis (gMG). In China, gMG has already been included in the "First Batch of Rare Diseases Catalog."

In October of this year, Johnson & Johnson also announced positive results from the Phase II/III Vibrance-MG study of Nipocalimab for treating AChR-positive adolescents (12-17 years old). Johnson & Johnson press release noted that this is the first FcRn inhibitor demonstrating sustained disease control effects for 24 weeks in AChR-positive adolescents aged 12-17, expanding the research population of Nipocalimab.