Rystiggo® is the commercial brand name of Rozanolixizumab Injection, a humanized anti-FcRn monoclonal antibody developed by UCB Pharma. It binds to the neonatal Fc receptor (FcRn), accelerates the clearance of pathogenic immunoglobulin G (IgG) autoantibodies in the body, reduces circulating autoantibody levels, and alleviates autoimmune-mediated tissue damage. The drug is administered via subcutaneous injection.
Main Indications
Treatment of adult patients with generalized myasthenia gravis (gMG) who are positive for acetylcholine receptor (AChR) antibodies;
Treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in adult patients to reduce disease relapse.
Clinical Research
Global multicenter Phase III pivotal clinical trials proved that rozanolixizumab achieved sustained reduction of IgG levels, obvious improvement in myasthenia gravis daily activity score and muscle weakness symptoms for generalized myasthenia gravis patients;
Registered clinical trials enrolling Chinese subjects verified consistent autoantibody-lowering efficacy and safety profiles consistent with overseas multi-center research data;
Long-term maintenance treatment trials showed durable disease control, reduced reliance on corticosteroids and immunosuppressants for autoimmune neuromuscular disease patients.
Common Side Effects
Frequent adverse reactions include headache, diarrhea, fever, fatigue, injection site reactions (erythema, pain, swelling);
Infrequent adverse events include upper respiratory tract infection, nausea, arthralgia; most adverse reactions are mild to moderate and tolerable during long-term administration.
Approval Status in China
Rystiggo® (Rozanolixizumab Injection, 280mg (2mL) per vial) was approved for marketing by the National Medical Products Administration of China for generalized myasthenia gravis, imported and marketed by UCB Pharma.
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