狄诺塞麦上市日期

Date of launch: Denosumab, also known as denosumab, was approved for marketing in the EU on May 28, 2010. In June 2010, denosumab was approved by the FDA for marketing in the United States. In 2019, denosumab was approved by the National Medical Products Administration for marketing in China.

Denosumab is a bone resorption inhibitor with a unique mechanism of action. It specifically targets receptor activator of nuclear factor kappa B ligand (RANKL), inhibits the activation and development of osteoclasts, reduces bone resorption, and increases bone density. The FDA approved denosumab for the treatment of postmenopausal women with osteoporosis who are at high risk of fracture. It can help reduce the incidence of vertebral, non-vertebral and hip fractures in postmenopausal women with osteoporosis. Denosumab can also be used to reduce the risk of fractures in patients who are currently ineffective or intolerant to other treatments.

Denosumab has a high affinity with RANKL, preventing RANK ligand 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 effect of denosumab on bone reconstruction can be evaluated by measuring some bone renewal markers, such as the bone resorption marker N-telopeptide, the bone formation marker bone-specific alkaline phosphatase, etc.

A phase I clinical study conducted in healthy postmenopausal women showed that a dose-dependent decrease in morning urine NTX levels was observed on day 2 after administration. This decrease lasted for 6 months, with the maximum decrease reaching 84% compared with baseline. This effect is reversible. When serum levels disappear, NTX levels can be seen to rise again, which reflects the reversibility of its effect on bone reconstruction. As treatment continues, these effects will persist for a new cycle.