地诺单抗在中国上市没呢？

(Denosumab) is a human monoclonal antibody, RANKL inhibitor, indicated for the treatment of osteoporosis, therapy-induced bone loss, metastasis to bone, and giant cell tumor of bone. Works by preventing the development of osteoclasts, cells that break down bone (bone resorption).

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.

Denosumab was developed by biotech company Amgen to reduce the risk of fractures in cancer patients. Denosumab is contraindicated in people with low blood calcium levels. The most common side effects are joint and muscle pain in the arms or legs.

Is it listed in China? On October 26, 2018, Amgen Pharmaceuticals submitted a marketing application in China. Denosumab was approved by the National Medical Products Administration in May 2019 for the treatment of giant cell tumors of bone that are unresectable or where surgical resection may result in severe functional disability, including adults and adolescent patients with skeletal maturity (defined as at least 1 mature long bone and body weight >45 kg).