狄诺塞麦国内上市了吗？

Has it been launched domestically? On May 23, 2019, the China National Medical Products Administration announced conditional approval of the import registration application for (Angavi) denosumab injection (alias: denosumab). 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. The launch of denosumab has brought a new treatment option to Chinese patients.

Denosumab’s overseas listing history:

Denosumab (desosumab) was developed by Amgen of the United States. 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 the treatment of prostate cancer by hormone ablation for the treatment of bone loss in men. It was approved for marketing by the European Commission on May 28, 2010.

Not long after, denosumab was also approved for marketing in the United States for postmenopausal women at risk of osteoporosis, under the trade name Prolia. In November 2010, denosumab was approved for the prevention of bone-related events in patients and the treatment of bone metastases to solid tumors. Trade name Xgeva. In June 2013, the U.S. FDA approved denosumab 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.

Denosumab’s domestic listing history:

In 2018, denosumab (desosumab) was included in the list of overseas new drugs in urgent clinical need (first batch) and entered the fast review channel of the National Medical Products Administration. In May 2019, it was officially approved for listing in my country.

It can effectively reduce the disease progression of patients, significantly prolong the occurrence time of bone adverse events, and improve the quality of life of patients. Denosumab is already on the market in the country, and the price is relatively high. The price of Amgen's Turkish version is much lower. You can consult the Medical Companion Travel Service for specific information.