地舒单抗在国内获批上市了吗？

Has it been approved for listing in China? Desosumab has been launched in my country in 2019. Let’s review the launch process of denosumab.

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. In June of the same year, denosumab was approved by the FDA for marketing.

In 2018, denosumab was included in the list of overseas new drugs in urgent clinical need (first batch) and entered the rapid review channel of the National Medical Products Administration. This approval makes denosumab the first and currently the only drug for the treatment of giant cell tumor of bone, bringing patients an innovative treatment option to control disease progression and improve quality of life.

On May 27, 2019, Amgen China announced that denosumab has been 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 a body weight ≥45 kg).

Desosumab 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.

It has a high affinity to RANKL, prevents RANK ligands from activating RANK on the surface of osteoclasts, inhibits osteoclast activation and development, reduces bone resorption, increases bone density and bone strength of both cortical bone and trabecular bone, promotes bone reconstruction, and reduces the incidence of vertebral, non-vertebral and hip fractures in postmenopausal osteoporotic women.