Xgeva在国内上市了吗？

Has it been launched in China? Xgeva has been approved for domestic marketing in 2019. On October 26, 2018, Amgen Pharmaceuticals submitted a marketing application for Xgeva in China, with the application name: denosumab. On May 23, 2019, China’s National Medical Products Administration announced conditional approval of the import registration application for (Xgeva) 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.

Xgeva is the first approved monoclonal antibody specifically targeting 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. Osteoclasts are responsible for bone resorption, and osteoclast precursors must have low levels of macrophage colony-stimulating factor and RANKL during their differentiation into mature osteoclasts.

It has a high affinity with RANKL, preventing RANK ligand from activating RANK on the surface of osteoclasts, inhibiting osteoclast activation and development, reducing bone absorption, and reducing the incidence of vertebral, non-vertebral and hip fractures in postmenopausal osteoporotic women. Hypocalcemia must be corrected before starting treatment with Xgeva. For patients who are prone to hypocalcemia and mineral metabolism imbalance (such as those with a history of hypoparathyroidism, thyroid surgery, parathyroid surgery, malnutrition, small bowel resection, severe renal insufficiency), clinical monitoring of creatinine and mineral levels is required, and such patients should be instructed to pay attention to the symptoms of hypocalcemia and to supplement adequate amounts of calcium and vitamin D.