地诺单抗国内上市了吗？

Binds to RANKL, a transmembrane or soluble protein that plays an important role in the formation, function, and survival of osteoclasts, the cells responsible for bone resorption, and regulates the release of calcium from bone. Through RANKL stimulation, osteoclast activity is enhanced, mediating the occurrence of bone metastasis bone pathology in solid tumors. In addition, giant cell tumors of bone contain stromal cells that express RANKL, and osteoclast-like giant cells express RANKL receptors, which signal to each other leading to osteolysis and tumor growth. Denosumab prevents RANKL from activating its receptor RANK expressed on the surface of osteoclasts, precursor cells, and osteoclast-like giant cells.

Is denosumab available in China?

Amgen China recently announced that Angavir (English brand name 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 Angarvi 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 treatment with neoadjuvant denosumab: 44% underwent surgery with less impact on function, and 37% avoided surgery. In unresectable patients, Denosumab resulted in effective long-term disease control, with a 5-year progression-free survival (PFS) rate of 88%.