地诺单抗上市了吗？价格多少？

In May 2019, it was approved by the National Medical Products Administration for the treatment of giant cell tumors of bone that are unresectable or whose surgical resection may cause severe functional disability, including adults and adolescent patients with skeletal maturity (defined as at least 1 mature long bone and body weight >45 kg). Since denosumab is conditionally approved for marketing in China and has not been fully popularized, the domestic price of denosumab is not very clear. According to past experience, the price of new drugs on the market in my country will be relatively high.

On December 17, 2009, the European Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on denosumab for the treatment of postmenopausal osteoporosis in women and hormone ablation for the treatment of prostate cancer and bone loss in men. Denosumab was approved for marketing by the European Commission on May 28, 2010.

On June 2, 2010, denosumab was approved by the United States (FDA) for use in postmenopausal women with the risk of osteoporosis, under the trade name Prolia.

In November 2010, denosumab was approved for the prevention of bone-related events in patients and the treatment of solid tumors with bone metastases. Denosumab is the first RANKL inhibitor approved by the FDA under the trade name Xgeva.

On June 13, 2013, the U.S. Food and Drug Administration approved denosumab for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or in which resection would result in significant morbidity.

It is understood that denosumab available in the United States is 60mg/1ml tube/box and priced at US$1,169.98, which is simply unaffordable for domestic patients.

Fortunately, the product produced by the American company Amgen has been launched in Turkey. The specification is 125mg/1ml tube/box. The price is equivalent to RMB 3,000, which can be said to be high quality and low price. Therefore, more and more patients are choosing denosumab, which is marketed in Türkiye by Amgen of the United States.