Johnson & Johnson: IMAAVY® Nipocalimab Injection approved for market by NMPA
On May 21, the NMPA website announced that Johnson & Johnson’s innovative drug with a novel mechanism,Nipocalimab Injection (trade name:IMAAVY®), officially received marketing approval from the National Medical Products Administration (NMPA). It can be used in combination with conventional treatment regimens for the treatment of antibody-positive generalized myasthenia gravis (gMG) in adults and adolescents aged 12 years and above, offering a new therapeutic option for patients with rare neuroimmunological diseases in China.
Nipocalimab is a fully human, specific antagonist of the neonatal Fc receptor (FcRn) with a differentiated, innovative mechanism of action. The drug binds to the FcRn with high affinity, blocks the binding and recycling of FcRn with pathogenic immunoglobulin G (IgG) antibodies, accelerates the degradation of pathogenic autoantibodies, reduces harmful IgG levels at the source, and precisely intervenes in the disease pathogenesis.
Previously, this product had been included in the priority review pathway by the CDE due to its outstanding clinical value. It is also the first imported biologic product approved for domestic segmented manufacturing in China, offering both clinical breakthrough and localization advantages.
This major new drug originated from Johnson & Johnson’s significant industrial layout. In August 2020, Johnson & Johnson acquired Momenta Pharmaceuticals for $6.5 billion, successfully obtaining this core innovative asset. Globally, Nipocalimab first received approval in the United States in April 2025, becoming at that time the world’s first and only FcRn blocker approved for both anti-AChR and anti-MuSK antibody-positive gMG, covering adults and adolescents aged 12 years and older. Subsequently, the drug obtained approval in major pharmaceutical markets such as the European Union, Japan, and the United Kingdom, expanding its global commercial footprint.
The successful approval in China will further improve the domestic precision treatment system for myasthenia gravis and help upgrade the diagnosis and treatment of rare neuroimmunological diseases in the country.
