Is denosumab available in China?

(Denosumab), trade names Prolia and Xgeva, is a human monoclonal antibody, RANKL inhibitor, indicated for the treatment of osteoporosis, therapy-induced bone loss, metastasis to bone, and giant cell tumor of bone. Works by preventing the development of osteoclasts, cells that break down bone (bone resorption). Desosumab was developed by biotech company Amgen to reduce the risk of fractures in cancer patients. Denosumab is contraindicated in people with low blood calcium levels. The most common side effects are joint and muscle pain in the arms or legs.

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 hormonal ablation of prostate cancer for the treatment of bone loss in men. Denosumab was approved by the European Commission on May 28, 2010.

On June 2, 2010, the brand name Prolia was approved by the United States (FDA) for use in postmenopausal women with the risk of osteoporosis.

In November 2010, the brand name Xgeva was approved for the prevention of bone-related events in patients and the treatment of solid tumors with bone metastasis. Denosumab is the first RANKL inhibitor to receive FDA approval.

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

On October 26, 2018, Amgen Pharmaceuticals submitted a marketing application 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 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.

Although denosumab has been approved for marketing in my country, it is conditionally approved, and it is less than five months since it was launched, which means that ordinary domestic patients still do not have access to this drug. Moreover, for Chinese patients, imported original research drugs, new drugs, and special effects drugs will definitely cost a lot of money even if they become popular one day!