狄诺塞麦国内上市没？

Has it been launched domestically? On October 26, 2018, Amgen Pharmaceuticals submitted a marketing application in China, with the application name: denosumab. On May 23, 2019, the China National Medical Products Administration announced conditional approval of the import registration application for denosumab Xgeva (denosumab, denosumab). However, denosumab is not yet commercially available in China. If denosumab is launched in China in the future, it will provide new treatment options for patients with bone metastasis from advanced malignant tumors.

Denosumab, also known as denosumab, is a bone resorption inhibitor with a unique mechanism of action. It specifically targets the receptor activator of NF-kB ligand (RANKL), inhibits the activation and development of osteoclasts, reduces bone resorption, and increases bone density. On December 17, 2009, the European Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on denosumab for the treatment of postmenopausal osteoporosis in women and hormonal ablation of prostate cancer for the treatment of bone loss in men. Denosumab was approved by the European Commission on May 28, 2010. Denosumab was first approved by the FDA in 2010 for the treatment of osteoporosis and has since been used to prevent bone-related diseases in adults with solid tumors and bone metastases. In 2013, the FDA approved it for the treatment of adults and skeletally mature adolescents with giant cell tumors that are unresectable or may lead to severe mortality after surgery. On October 26, 2018, Amgen Pharmaceuticals submitted a marketing application in China, with the application name: denosumab.

Mainly, 120 mg is given by subcutaneous injection into the upper arm, upper thigh, or abdomen once every 4 weeks; calcium and vitamin D are given when treatment or prevention of hypocalcemia is needed. Xgeva denosumab (Prolia) is a prescription oncology drug that has certain toxic side effects and must be used under the guidance of a doctor with experience in drug use.