狄诺塞麦中国上市了吗？

Is it listed in China? On May 27, 2019, Amgen China announced that denosumab injection has been approved by the National Medical Products Administration for the treatment of giant cell tumors of bone that are unresectable or that may result in severe functional impairment after surgical resection, including adults and adolescent patients with skeletal maturity (defined as at least 1 mature long bone and body weight >45 kg). Denosumab, also known as denosumab, is the first and currently only drug used in the treatment of giant cell tumor of bone in China, bringing patients an innovative treatment option to control disease progression and improve quality of life.

Denosumab (desosumab) is a RANK ligand (RANKL) inhibitor with a different mechanism of action than currently approved drugs that reduce skeletal complications of tumors. It is a fully humanized monoclonal antibody (IgG2 monoclonal antibody) that specifically targets receptor activator of nuclear factor-κB ligand (RANKL). It prevents RANKL from binding to its receptor substances, inhibits osteoclast activation and development, reduces bone resorption, and increases bone density.

Denosumab requires subcutaneous injection (upper arm, upper thigh, or abdomen) of 120 mg every 4 weeks, along with calcium or vitamin D infusion to prevent hypocalcemia. Pregnant women and children should use it with caution. Patients with allergies and hypocalcemia are prohibited from using it.

Hypocalcemia must be corrected before initiating treatment with denosumab. 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.

The launch of (Denosumab) in China provides a new treatment option for domestic patients, which can effectively control the progression of the disease and extend the survival period of patients. It is good news for domestic patients with bone metastasis.