How much does denosumab cost in China?

Giant cell tumor of bone (GCTB) is a benign invasive (borderline) bone tumor. First reported by Cooper and Travers, GCTB accounts for approximately 5% of primary bone tumors in the United States and is more common in China and India, accounting for approximately 20% of all primary bone tumors. GCTB is most common in people between the ages of 20 and 40, and is more common in women. In the past, systemic treatments for GCTB included bisphosphonates, chemotherapy, interferon-α, dasatinib, and sunitinib. Most evidence-based medicine does not have a high level of evidence and is not a commonly used standard treatment. In recent years, (denosumab) has attracted widespread attention as a new treatment modality. GCTB contains two components: multinucleated osteoclast-like giant cells and mononuclear stromal cells. The latter can express RANKL. The RANKL/RANK signaling pathway is the key to initiating the osteoclast process in the pathogenesis of GCTB. Denosumab is a fully human monoclonal antibody with high affinity for RANKL (receptor activator of nuclear factor KB ligand). It inhibits the osteoclast process by blocking this signaling pathway.

Denosumab was originally developed by Amgen to treat osteoporosis. In 2004, a phase I clinical trial initially verified the efficacy and safety of denosumab in inhibiting bone resorption. Later, in 2009, a randomized controlled trial (FREEDOMTrial) including 7868 female patients with osteoporosis confirmed that the denosumab group could significantly reduce the risk of fracture by 32% compared with the placebo control group (p<0.001). At the same time, Smith et al (Denosumab HALT Prostate Cancer Study Group) reported a randomized controlled trial involving 1,468 patients with non-metastatic prostate cancer who had undergone castration treatment. Denosumab treatment can increase bone density and reduce the risk of new vertebral fractures.

In 2011, in a randomized, double-blind trial of denosumab versus zoledronic acid, Henry et al. reported that denosumab was no less effective than zoledronic acid in reducing or preventing skeletal-related events (SREs) in patients with advanced cancer (breast cancer, prostate cancer) bone metastasis and multiple myeloma. Based on the above and related clinical research findings, the FDA (U.S. Food and Drug Administration) in 2010 and the EMA (European Medicines Agency) in 2011 approved denosumab for osteoporosis (postmenopausal osteoporosis), delaying the occurrence of bone-related events in patients with bone metastases, and bone loss induced by aromatase and androgen deficiency.

Although the country conditionally approved denosumab for marketing in May 2019, due to the conditional approval and the fact that it was only on the market for five months, the domestic selling price of this drug cannot be collected. What is certain is that as imported original research drugs, new drugs, and special effects drugs, the domestic prices must be very high.