Enspryng® is the official global commercial brand name, and Anshiping is its Chinese brand name developed by Roche. It is a humanized anti-interleukin-6 receptor (IL-6R) monoclonal antibody. It selectively binds to IL-6 receptor, blocks IL-6 signal transduction, suppresses abnormal autoimmune inflammatory responses, and reduces the relapse risk of neuromyelitis optica spectrum disorder.
Main Indications
Treatment of neuromyelitis optica spectrum disorder (NMOSD) in adolescents aged 12 years and older and adults who are aquaporin-4 (AQP4) antibody positive. It can be used as monotherapy or combined with immunosuppressive therapy.
Clinical Research
Two pivotal randomized, placebo-controlled global phase III clinical trials confirmed that satralizumab significantly reduces the annualized relapse rate in AQP4 antibody-positive NMOSD patients, whether administered alone or combined with immunosuppressants. Long-term extension studies demonstrated sustained relapse-prevention efficacy and stable safety profile over multiple years of treatment. Subcutaneous administration enables convenient home self-injection for patients.
Common Side Effects
Severe risks: Increased susceptibility to serious infections including tuberculosis, hepatitis B reactivation; hypersensitivity reactions.
Common mild adverse reactions: Upper respiratory tract infection, headache, arthralgia, fatigue, injection-related reactions, elevated liver enzymes, diarrhea.
Approval Status in China
Original drug Enspryng® (Satralizumab Injection, Chinese brand name: Anshiping®) was officially approved for marketing in China in May 2021, with the specification of 120mg (1mL) single-dose prefilled syringe. It is a prescription rare disease biologic drug included in China’s medical insurance catalogue.
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