China-based Shanghai Henlius Biotech Inc. (HKG: 2696) has announced the first patient dosing in a global multi-center Phase III clinical study for its drug candidate HLX14, a biosimilar of Amgen’s Prolia/Xgeva (denosumab). The study targets the treatment of postmenopausal osteoporosis in women at high risk of fracture.
Clinical Trial Design
The randomized, double-blind, global multi-center, parallel-controlled Phase III study assesses HLX14’s efficacy, safety, tolerability, and immunogenicity. Subjects are randomized 1:1 to receive subcutaneous injections of HLX14 or the originator every six months for two cycles. The primary endpoint is the rate of change in lumbar spine bone mineral density (BMD) from baseline to Week 52 (D365).
Drug Background
Denosumab, a recombinant anti-RANKL human monoclonal antibody injection, treats conditions including postmenopausal osteoporosis in high-risk women. A Phase I study for the drug began in November 2020. Amgen’s Prolia/Xgeva is marketed globally, including in China, generating USD 5.85 billion in global sales in 2021, with RMB 156 million (USD 23.3 million) from China.
Commercialization Deal
Henlius recently signed a licensing agreement with US-based Organon (NYSE: OGN), granting exclusive commercialization rights to its biosimilars of Perjeta (pertuzumab, HLX11) and Prolia/Xgeva (denosumab, HLX14) outside Greater China.-Fineline Info & Tech
