CSPC Pharmaceutical Group Limited (CSPC Pharma) has obtained a drug registration certificate from China’s National Medical Products Administration (NMPA) for Enlida® (Batoclimab Injection, subcutaneous), an in-licensed therapy from Harbour Biomed (Shanghai) Co., Ltd. The product is approved for use alongside conventional drugs to treat adult patients with anti-acetylcholine-receptor-positive generalized myasthenia gravis (gMG).

gMG is a rare, chronic autoimmune neuromuscular disorder characterised by fluctuating skeletal-muscle weakness and potential life-threatening crises. Current treatments—including cholinesterase inhibitors, glucocorticoids and other immunosuppressants—leave material unmet needs in efficacy, safety, accessibility and cost.

Batoclimab is a fully human monoclonal antibody that targets the neonatal Fc receptor (FcRn). By blocking FcRn-mediated recycling of immunoglobulin G, the drug accelerates degradation of pathogenic autoantibodies responsible for gMG. It is the first anti-FcRn therapy to complete full clinical development for gMG in China.

Approval was primarily underpinned by a pivotal Phase III study across 27 Chinese centres. Among adult patients positive for AChR or MuSK antibodies, 58.2% of those receiving batoclimab achieved sustained improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores during the first treatment cycle, versus 31.3% for placebo (P = 0.001). Benefits emerged as early as week 2 and extended to key secondary endpoints, including sustained Quantitative Myasthenia Gravis score improvements, longer maintenance of MG-ADL responses, and higher rates of minimal symptom expression (MG-ADL ≤ 1). The treatment demonstrated an acceptable safety profile.

The NMPA certificate positions CSPC Pharma to commercialise Enlida® in China, potentially broadening therapeutic options for thousands of adults managing gMG.