Batoclimab Wins NMPA Approval for AChR Antibody Positive Adult Generalized Myasthenia Gravis

CSPC Pharmaceutical and HBM Pharmaceuticals' batoclimab injection has been approved by the NMPA, in combination with conventional therapy, for adults with generalized myasthenia gravis who are AChR antibody positive. The drug is given subcutaneously at 170 mg (1 mL) per vial. NMPA posted the approval on October 22, with the applicant listed as Jiaxi Holdings Limited and the trademark holder as CSPC Pharmaceutical. The source views it as the fourth FcRn antagonist to land in China in the second half of 2026, after Johnson & Johnson's nipocalimab, and says it is the first anti-FcRn therapy to complete full clinical development for gMG in China.