地诺单抗国内上市没？

It is a drug targeting the RANK ligand. Compared with bisphosphonates that have been used clinically, denosumab has the advantage of significantly prolonging the occurrence time of bone damage-related events. It can be administered subcutaneously in clinical practice and is easy to use. Moreover, clinical data shows that the drug does not require monitoring of renal function, while the use of bisphosphonates must be based on patient Renal function monitoring determines the speed of administration; however, denosumab is currently relatively expensive, and the balance between its long-term efficacy and cost-effectiveness needs to be further confirmed. It is expected that denosumab, a drug specifically targeting RANK ligand inhibitors, can obtain more valuable research results in the treatment of solid tumors and bring new hope to patients with bone metastasis. Since the therapeutic effect of denosumab is so good, has it been launched in the country?

On May 27, 2019, Amgen China announced today 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 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 body weight >45 kg). 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 in China for the treatment of giant cell tumor of bone, bringing patients an innovative treatment option to control disease progression and improve quality of life.

The approval of denosumab is based on the results of two open-label trials in patients with recurrent, unresectable giant cell tumor of bone or in whom planned surgical resection is likely to cause severe functional disability. The latest analysis of the study, presented at the European Society for Medical Oncology (ESMO) Annual Meeting in 2017, showed that among patients who could be surgically resected, 80% improved after receiving neoadjuvant denosumab: 44% underwent surgery with less impact on function, and 37% avoided surgery. In unresectable patients, it resulted in effective long-term disease control, with a 5-year progression-free survival (PFS) rate of 88%.