China-based Shanghai Henlius Biotech Inc. (HKG: 2696) received approval from Australia’s Therapeutic Goods Administration (TGA) to conduct a global multi-center Phase III study of HLX14, its biosimilar of Amgen’s Prolia/Xgeva (denosumab), targeting postmenopausal osteoporosis in high-fracture-risk women.
Study Details
The trial will evaluate the efficacy, safety, tolerability, and immunogenicity of HLX14 compared to the originator drug. The first patient was dosed in June 2022 in a China-based Phase III study, with Organon LLC securing exclusive commercialization rights outside China via a licensing deal with Henlius.
Drug Profile
Denosumab is a recombinant anti-RANKL monoclonal antibody used to treat osteoporosis in postmenopausal women at high fracture risk. HLX14 aims to offer a biosimilar alternative, with the Phase III study designed to demonstrate equivalence in therapeutic effect.
Global Development
Henlius plans to expand the study’s global reach, leveraging the TGA approval to enroll patients in Australia and other regions. The partnership with Organon underscores efforts to commercialize HLX14 worldwide.-Fineline Info & Tech
