China’s drug regulator has granted approval for batoclimab injection, a treatment designed for adult patients with generalized myasthenia gravis who test positive for specific antibodies. The National Medical Products Administration (NMPA) approved the Biologics License Application (BLA) for the 170 mg (1 mL)/vial formulation, marking the entry of a new option into the market for this chronic autoimmune condition. Harbour BioMed announced the approval, which supports the use of the drug for patients with anti-acetylcholine receptor (AChR) antibody positivity.
Phase 3 Results Show Significant Improvement
The decision is based on data from a key phase 3 study conducted across 27 centers in China. The trial included patients with generalized myasthenia gravis who were positive for acetylcholine receptor antibodies (AChR-Ab) or muscle-specific tyrosine kinase antibodies (MuSK-Ab). The primary endpoint measured the proportion of patients achieving sustained improvement in the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) score during the first treatment cycle. Sustained improvement was defined as a reduction of at least 3 points from baseline that persisted for four weeks.
Among the treated group, 58.2 percent of patients met this primary endpoint, a statistically significant figure compared to the 31.3 percent rate observed in the placebo group. Treatment effects became evident as early as the second week of therapy. Secondary endpoints also showed marked improvements, including a higher rate of sustained quantitative myasthenia gravis (QMG) improvement (64.2 percent versus 40.6 percent), a greater duration of 3-point or greater MG-ADL improvement (51.5 percent versus 36.1 percent), and a higher proportion of patients reaching a minimal symptom state (25.4 percent versus 4.7 percent).
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The drug was generally well tolerated during the trial. The most frequently reported adverse event in the treatment group was peripheral edema, which occurred in 38.8 percent of patients compared to 4.6 percent in the placebo group. All instances of this side effect were classified as mild to moderate in severity. Plasma albumin levels decreased during treatment but returned to normal levels after the medication was stopped.
Regulatory Context and Market Strategy
The agreement between Harbour BioMed and NBP Pharma was signed in October 2022. This partnership outlines the commercialization strategy for batoclimab in the region. Harbour BioMed is a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other areas.
Targeting the Disease Mechanism
Batoclimab functions by targeting the neonatal Fc receptor. This receptor is responsible for recycling IgG antibodies. Batoclimab blocks this recycling process. Consequently, pathogenic autoantibodies are degraded more quickly. This mechanism offers a targeted approach. The drug was originally developed by HanAll Biopharma. The company licensed the rights to Harbour BioMed in 2017. The collaboration was established through a strategic agreement. This partnership allowed batoclimab to complete its clinical development in China.
