地诺单抗国内上市日期

(Denosumab) When is the launch date in China? Denosumab, developed by biotech company Amgen, may reduce the risk of fractures in cancer patients. Denosumab (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. Denosumab (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 (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.

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 for which 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).

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