Remicade® is the commercial brand name of Infliximab for Injection, a chimeric monoclonal antibody targeting tumor necrosis factor alpha (TNF-α) developed by Janssen Biologics. It specifically binds to soluble and membrane-bound TNF-α to block inflammatory signaling pathways and suppress excessive autoimmune inflammatory responses.
Main Indications
Treatment of rheumatoid arthritis and ankylosing spondylitis;
Treatment of Crohn’s disease in adults and children aged 6 years and above;
Treatment of plaque psoriasis and psoriatic arthritis;
Treatment of ulcerative colitis in adults and children aged 6 years and above.
Clinical Research
Global multicenter phase III trials demonstrated that infliximab effectively relieves inflammatory symptoms, inhibits joint destruction and promotes mucosal healing in patients with rheumatic and inflammatory bowel diseases;
Registration trials among Chinese patients confirmed stable therapeutic efficacy and comparable tolerability data with global research populations;
Long-term clinical observation studies verified sustained disease control after regular intravenous infusion and a predictable safety profile.
Common Side Effects
Severe but important risks: Serious opportunistic infections including tuberculosis, invasive fungal infections, malignant tumors, infusion-related hypersensitivity reactions, hepatic injury;
Common mild adverse reactions: Headache, nausea, fatigue, upper respiratory tract infection, abdominal discomfort and rash.
Approval Status in China
Original drug Remicade® (Infliximab for Injection) was officially approved for marketing in China in 2007. It is currently a prescription biologic drug included in China’s Category B medical insurance catalogue.
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