地诺单抗国内有吗？

(Denosumab) Is it available in China? Let's take a look. Denosumab (Denosumab) was approved by the National Medical Products Administration in May 2019 for the treatment of giant cell tumor of bone that is unresectable or where surgical resection may cause severe functional disability, including adults and adolescent patients with skeletally mature disease (defined as at least 1 mature long bone and body weight >45 kg).

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

On June 2, 2010, denosumab (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 (denosumab) was approved for the prevention of bone-related events in patients and the treatment of solid tumors with bone metastases. Denosumab (Denosumab) is the first RANKL inhibitor approved by the FDA under the trade name Xgeva. On June 13, 2013, the U.S. FDA approved denosumab (denosumab) for the treatment of adults and skeletally mature adolescents with giant cell tumors of bone that are unresectable or where resection would result in significant morbidity.

It is understood that denosumab (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. Denosumab (Denosumab) produced by Amgen in the United States has been launched in Turkey. The specification is 125mg/1ml tube/box, and the price is equivalent to RMB 3,000.

Denosumab (Denosumab) is conditionally approved for marketing in China and has not been fully popularized, so the domestic price of (Denosumab) is not very clear.

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