Benlysta® is the commercial brand name of Belimumab powder for concentrate for solution for infusion, a human monoclonal antibody developed by GSK. It binds to soluble B lymphocyte stimulator (BLyS), inhibits the survival of autoreactive B cells, lowers the level of autoantibodies, and relieves autoimmune inflammatory damage.
Main Indications
Treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus on standard therapy;
Treatment of adult patients with active lupus nephritis receiving standard treatment.
Clinical Research
Global multicenter phase III BLISS-52 and BLISS-76 pivotal trials confirmed that belimumab significantly improves disease activity and reduces the risk of severe flares in patients with systemic lupus erythematosus.
Phase III BLISS-LN trial demonstrated improved renal endpoints for patients with active lupus nephritis treated with belimumab combined with standard therapy.
Long-term open-label extension studies verified sustained disease control and persistent reduction of flare frequency after repeated intravenous infusions.
Dose-finding trials confirmed favorable efficacy and manageable infusion tolerability of the 120mg loading dose regimen.
Chinese domestic registration trials validated consistent therapeutic effects and acceptable safety profiles in local patients with lupus.
Common Side Effects
Common mild adverse reactions: Nausea, diarrhea, pyrexia, fatigue, headache and upper respiratory tract infections;
Laboratory abnormalities: Transient mild leukopenia;
Severe but uncommon risks: Severe hypersensitivity and infusion-related reactions, serious infections and psychiatric adverse events.
Approval Status in China
Original drug Benlysta® (Belimumab powder for concentrate for solution for infusion) was officially approved for marketing in China in 2019, with the specification of 120mg per vial, 1 vial per box. It is currently a prescription biologic drug included in China’s Category B medical insurance catalogue.
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