地诺单抗获批的适应症有什么呢？

It is a new type of RANKL inhibitor developed by Amgen. It is a fully human monoclonal IgG2 antibody of RANKL. It has high affinity and specificity for the soluble, transmembrane form of human RANKL. On May 28, 2010, the European Commission approved denosumab for the treatment of bone loss associated with hormone suppression in postmenopausal women with osteoporosis and prostate cancer. It can also be used in patients who are currently ineffective or intolerant to other treatments to reduce the risk of fractures.

On June 13, 2013, denosumab was approved to treat adults and adolescents with giant cell tumor of bone (GCTB), a rare and usually noncancerous tumor.

On May 27, 2019, Amgen China announced that denosumab injection has been approved by the National Medical Products Administration for the treatment of giant cell tumors of bone that are unresectable or that may result in severe functional disability after surgical resection, including adults and adolescent patients with skeletal maturity (defined as at least 1 mature long bone and body weight >45 kg).

Denosumab is the first approved monoclonal antibody that specifically targets RANK ligand. RANK ligand is a transmembrane or soluble protein that is necessary for osteoclasts to maintain their structure, function, and survival. Human RANKL mRNA is mainly found in bones, bone marrow and lymphoid tissues. Its main function in bones is to stimulate the differentiation and activity of osteoclasts and inhibit the apoptosis of osteoclasts. Denosumab has a high affinity for RANKL, preventing RANK ligands from activating RANK on the surface of osteoclasts, inhibiting osteoclast activation and development, reducing bone resorption, increasing bone density and bone strength of both cortical bone and trabecular bone, promoting bone reconstruction, and reducing the incidence of vertebral, non-vertebral and hip fractures in postmenopausal osteoporotic women. 

The above are the relevant approved indications. If you have any other questions, please consult the medical companion travel service.