Shanghai Henlius Biotech Inc. (HKG: 2696) and its US partner Organon (NYSE: OGN) have jointly announced that the Biologic License Application (BLA) for HLX14, an investigational biosimilar of Amgen’s (NASDAQ: AMGN) Prolia/Xgeva (denosumab), has been accepted for review by the US Food and Drug Administration (FDA).
Denosumab, a recombinant anti-RANKL human monoclonal antibody injection, is indicated for various conditions, including 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. In June 2022, Henlius entered into a licensing agreement with Organon, granting the company exclusive commercialization rights to Henlius’s biosimilars of Perjeta (pertuzumab, HLX11) and Prolia/Xgeva (denosumab, HLX14) in global territories outside Greater China.- Flcube.com
