Tremfya® is the commercial brand name of Guselkumab Injection, a fully human monoclonal antibody against IL‑23p19 developed by Janssen. It specifically binds interleukin‑23 to interrupt the inflammatory cascade, alleviating immune-mediated inflammatory lesions.
Main Indications
Treatment of moderately to severely active Crohn’s disease in adult patients with inadequate response, loss of response or intolerance to conventional therapy or biologic agents;
Treatment of moderate to severe plaque psoriasis suitable for systemic therapy in adult patients;
Treatment of active psoriatic arthritis in adult patients.
Clinical Research
Global multicenter phase III pivotal trials confirmed that guselkumab induces clinical remission and mucosal improvement in inflammatory bowel disease and achieves high skin clearance rates in plaque psoriasis;
Registration trials conducted in Chinese patients showed consistent therapeutic efficacy and comparable safety data with global research cohorts;
Long-term extension studies validated stable disease control during long-term maintenance administration and a predictable safety profile.
Common Side Effects
Severe but important risks: Serious infections including tuberculosis and invasive fungal infections, severe hypersensitivity reactions, hepatic impairment;
Common mild adverse reactions: Upper respiratory tract infection, headache, arthralgia, diarrhoea, fatigue and injection site reactions.
Approval Status in China
Original drug Tremfya® (Guselkumab Injection) was officially approved for marketing in China, with the intravenous infusion specification of 200mg/20mL per vial. It is a prescription biologic agent.
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