NMPA approves CSPC's subcutaneous batoclimab for AChR antibody-positive adult generalized myasthenia gravis

CSPC Pharmaceutical Group announced that subcutaneous batoclimab has received a drug registration certificate from the NMPA for use in combination with conventional therapy in AChR antibody-positive adults with generalized myasthenia gravis. The approval is based on a pivotal Phase III study conducted at 27 sites in China, in which 58.2% of the treatment group reached the primary endpoint versus 31.3% on placebo (P=0.001), with efficacy seen as early as week two. Secondary endpoints also improved significantly versus placebo, and the drug was generally well tolerated.