Stelara® is the official global commercial brand name, and Xidanuo is its Chinese brand name developed by Janssen. It is a fully‑human monoclonal antibody. It targets the p40 subunit of interleukin‑12 (IL‑12) and interleukin‑23 (IL‑23), blocks abnormal inflammatory signalling pathways, restores normal immune homeostasis and suppresses excessive inflammatory responses of immune‑mediated inflammatory diseases.
Main Indications
Treatment of moderate‑to‑severe plaque psoriasis in adults and children aged 6 years and older with inadequate response or intolerance to other systemic therapies or phototherapy;
Treatment of moderately to severely active Crohn’s disease in adults with inadequate response to conventional therapy or anti‑TNF‑α agents.
Clinical Research
Global multicenter phase 2 and phase 3 pivotal trials demonstrated that ustekinumab achieves significant skin lesion clearance in patients with plaque psoriasis after induction treatment, and sustained clinical benefits can be maintained with a once‑every‑12‑week subcutaneous maintenance regimen;
Clinical trials including Chinese patients confirmed consistent efficacy and safety profiles comparable to global study populations;
Crohn’s disease clinical trials validated its efficacy in inducing and maintaining clinical remission among adult patients with active disease.
Common Side Effects
Increased susceptibility to infections: upper‑respiratory‑tract infection, nasopharyngitis, sinusitis; severe infections including tuberculosis and invasive fungal infections (rare but severe);
Common mild adverse reactions: headache, fatigue, diarrhoea, nausea, injection‑site erythema, pruritus, back pain, arthralgia and allergic reactions. Malignancy risk may be elevated due to immunomodulatory properties (rare).
Approval Status in China
Original drug Stelara® (Ustekinumab Injection) was officially approved for marketing in China in 2017, with specifications of 45 mg/0.5 mL and 90 mg/1.0 mL. It has been included in China’s national medical insurance catalogue since 2021.
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