Nexavar® is the official global commercial brand name, and Duojimei is its Chinese brand name developed by Bayer. It is an oral multi-target kinase inhibitor. It simultaneously suppresses Raf serine/threonine kinases and VEGFR/PDGFR tyrosine kinases, inhibiting both tumor cell proliferation and angiogenesis.
Main Indications
Treatment of unresectable hepatocellular carcinoma in adults;
First-line treatment of advanced renal cell carcinoma in adults;
Treatment of locally recurrent or metastatic, progressive differentiated thyroid carcinoma refractory to radioactive iodine therapy.
Clinical Research
Global multicenter phase III pivotal trials fully validated its overall survival benefit for patients with advanced hepatocellular carcinoma and renal cell carcinoma;
Head-to-head controlled trials confirmed significant tumor stabilization and prolonged survival compared with placebo for late-stage liver cancer;
Long-term follow-up cohort studies demonstrated sustained disease control under continuous twice-daily oral administration;
Dose-finding research verified balanced anti-tumor efficacy and cutaneous tolerability of the 0.2g twice-daily standard regimen;
Chinese domestic registration trials confirmed consistent therapeutic activity and manageable adverse reaction spectrum for local liver, kidney and thyroid tumor populations.
Common Side Effects
Common mild adverse reactions: Hand-foot skin reaction, rash, diarrhea, fatigue, alopecia and pruritus;
Laboratory abnormalities: Transient mild liver transaminase elevation, hypophosphatemia and lymphopenia;
Severe but uncommon risks: Severe hand-foot syndrome, gastrointestinal perforation, severe hypertension, hemorrhage and cardiac ischemia.
Approval Status in China
Original drug Nexavar® (Chinese brand: Duojimei) was officially approved for marketing in China in 2006, with the specification of 0.2g per tablet, 60 tablets per box. It is currently a prescription targeted anti-tumor drug included in China’s Category B medical insurance catalogue.
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