美国安进的地舒单抗在国内上市了吗？

The earliest indication was approved for the treatment of unresectable giant cell tumor of bone. Desosumab can significantly reduce tumor size, inhibit bone destruction, and block pathological development. Desosumab is the first RANKL inhibitor approved by the FDA. So, has Amgen’s denosumab been launched in China?

On May 27, 2019, denosumab was approved by the National Medical Products Administration for the treatment of giant cell tumor of bone that is 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).

Amgen is principally engaged in the discovery, development, production and sales of innovative drugs for human use, and is committed to exploring the potential of biotechnology for the treatment of patients with serious diseases. As a leader in the global biopharmaceutical industry, Guizhou has strong R&D capabilities and product advantages. It insists on developing in the field of biotechnology for disease treatment. Its main fields include human genome, cancer, neuroscience and small molecule chemistry.

Desosumab is a fully humanized immunoglobulin (Ig) G2 monoclonal antibody prepared using recombinant DNA technology. Its target is receptor activator of nuclear factor-κB ligand (RANKL).

Large-scale clinical trials abroad have proven that denosumab can significantly improve bone turnover markers (BTM) in postmenopausal osteoporosis patients, including a significant reduction in the bone resorption markers C-telopeptide of type I collagen (CTX) and N-telopeptide of type I procollagen (PINP). At the same time, the bone mineral density (BMD) of the subjects' lumbar spine and hip joints was significantly increased. In its 2010 guidelines for the treatment of postmenopausal osteoporosis, the American Society of Clinical Endocrinologists listed denosumab as a first-line drug along with bisphosphonates.

On June 13, 2013, the U.S. FDA approved it for the treatment of adults and skeletally mature adolescents with giant cell tumors of bone that are unresectable or in which resection would result in significant morbidity.