狄诺塞麦国内哪能买到?
(denosumab, also known as AMG-162, trade name Prolia) is a bone resorption inhibitor with a unique mechanism of action. It specifically targets receptor activator of nuclear factor kappa B (RANK) ligand, inhibits the activation and development of osteoclasts, reduces bone resorption, and increases bone density. 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. Denosumab was approved for the first time in 27 EU member states, as well as Norway, Iceland, and Liechtenstein. In June of the same year, denosumab was approved by the FDA. In addition, denosumab is a drug that targets the RANK ligand. Compared with the 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 and is easy to use. Clinical data shows that the drug does not require monitoring of renal function, while the use of bisphosphonates does. The dosing speed is determined based on the patient's renal function monitoring; 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.
On May 23, 2019, China’s National Medical Products Administration announced conditional approval of the import registration application for Denosumab Injection (English name: Denosumab Injection). The drug will be used to treat adults and skeletally mature adolescent patients with unresectable giant cell tumors of bone or whose surgical resection may result in severe functional impairment.
Even though denosumab has been approved in China, it is subject to conditional approval, and the approval is less than five months away. Therefore, it is difficult for ordinary domestic patients to have access to this drug. It is not sold in large domestic hospitals and pharmacies. It can be said that denosumab is not available in China. Even if denosumab is sold publicly in China one day, given its status as an imported original research drug, new drug, and special effect drug, the domestic price will definitely be high.
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