Shandong Boan Biotechnology Co., Ltd (HKG: 6955), a controlling subsidiary of China-based Luye Pharma Group (HKG: 2186), has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for BA1102, a biosimilar version of Amgen’s Xgeva (denosumab). BA1102 is now approved for use in treating giant cell tumors of bone that are not removable through surgery or that may result in severe functional impairment, including adult and adolescent patients with mature bone development (defined as at least one mature long bone and a weight of ≥ 45 kg).
Denosumab, a novel RANKL inhibitor originally developed by Amgen, is currently marketed in China by BeiGene. The 120mg dosage form of the drug, sold under the brand name Xgeva, received approval in China in May 2019. Another dosage form, 60mg under the brand name Prolia for treating bone loss (osteoporosis) in at-risk patients, was approved in June 2020. Phase I and Phase III head-to-head clinical studies comparing BA1102 with denosumab have confirmed their similarity in pharmacokinetics, pharmacodynamics, clinical efficacy, and safety.- Fineline.com
