China-based Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its pipeline drug LY06006/BA6101, a biosimilar version of Amgen’s Xgeva (denosumab). The approval is for the treatment of osteoporosis in postmenopausal women at high risk of fracture.
Denosumab Profile
Denosumab, a novel RANKL inhibitor originated by Amgen and currently marketed in China by BeiGene, is a fully humanized monoclonal IgG2 antibody with high affinity and specificity for the soluble and transmembrane forms of human RANKL. The 120mg dosage form of the product, marketed as Xgeva, was approved in China in May 2019 for use in adults and adolescents with mature skeletal development (defined as at least one mature long bone and a weight of ≥45 kg) with inoperable giant cell tumor of bone or surgically removed giant cell tumors of bone that may cause severe dysfunction. It was commercially launched in December of the same year. The 60mg dosage form, sold under the trade name Prolia and used to treat bone loss (osteoporosis) in at-risk patients, was approved in China in June 2020.
LY06006/BA6101 Development
LY06006/BA6101, the world’s first Prolia biosimilar, has now received approval in China. The drug is also being prepared for clinical and market filings in Europe and the United States. This marks a significant step forward in expanding access to effective osteoporosis treatments globally.
Competitive Landscape
Meanwhile, other versions of the drug are still awaiting regulatory decisions in China. Qilu’s version is still under review, while Innovent Bio’s IBI307, Genor Bio’s GB223, and Henlius’s HLX14 are also under development. This competitive landscape highlights the growing interest in biosimilar development for osteoporosis treatments.-Fineline Info & Tech
