Shanghai Henlius Biotech Inc. (HKG: 2696), a biopharmaceutical company based in China, has announced that the European Medicine Agency (EMA) has accepted two marketing approval filings for its drug candidate HLX14, a biosimilar version of Amgen’s Prolia/Xgeva (denosumab).
Denosumab, a recombinant anti-RANKL human monoclonal antibody injection, is utilized for various indications, including the treatment of postmenopausal women with osteoporosis who are at a high risk of fracture. In June 2022, Henlius entered into a licensing agreement with US-based Organon (NYSE: OGN), which granted Organon exclusive commercialization rights to Henlius’s biosimilars of Perjeta (pertuzumab, HLX11) and Prolia/Xgeva (denosumab, HLX14) in global markets outside of Greater China.
The two filings with the EMA encompass all the indications of denosumab approved in the European Union (EU). These include the treatment of postmenopausal women with osteoporosis at high risk of fracture, certain patients with giant cell tumor of bone, skeletal-related events in patients with multiple myeloma, and patients with bone metastases from solid tumors.- Flcube.com
