Xgeva® is the official global commercial brand name, and Anjiawei is its Chinese brand name developed by Amgen. It is a fully‑human monoclonal antibody against RANKL. It binds to RANKL specifically, inhibits osteoclast formation, activation and survival, thereby reducing bone destruction.
Main Indications
Treatment of giant cell tumour of bone in skeletally mature adults and skeletally mature adolescents whose epiphyses have closed and who are unresectable or where surgical resection is likely to result in severe morbidity;
Prevention of skeletal‑related events in patients with bone metastases from solid tumours.
Clinical Research
Global multicenter phase II pivotal trials demonstrated that denosumab induced tumour response and controlled bone lesions in patients with unresectable giant‑cell tumour of bone;
Global phase III head‑to‑head trials confirmed denosumab was superior to zoledronic acid in preventing skeletal‑related events among patients with solid‑tumour bone metastases;
Clinical trials including Chinese subjects showed consistent efficacy and safety outcomes compared with global study populations;
Long‑term follow‑up data validated durable tumour control for giant‑cell tumour of bone.
Common Side Effects
Hypocalcaemia (rare but severe);
Common mild adverse reactions: fatigue, back pain, extremity pain, musculoskeletal pain, nausea, diarrhoea;
Increased risk of infection, osteonecrosis of jaw, atypical femoral fracture.
Approval Status in China
Original drug Xgeva® (Denosumab Injection) was officially approved for marketing in China in 2019, with the specification of 120 mg (1.7 mL)/vial. It is currently a prescription drug included in China’s national medical insurance catalogue.
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