The board of directors of Shanghai Henlius Biotech, Inc. announced that, recently, a phase 1 clinical study of a biosimilar of denosumab HLX14 (recombinant anti-RANKL human monoclonal antibody injection) ("HLX14") independently developed by the Company in Chinese healthy adult male subjects, has been successfully completed. The results of the study suggest that HLX14 had highly similar pharmacokinetics (PK) and pharmacodynamics (PD), as well as comparable safety, tolerability, and immunogenicity to the reference drugs (defined as follows) from different sources. This study met all of the pre-specified endpoints.

This is a two-part phase 1 clinical study in Chinese healthy adult male subjects. Part 1 is an open-label, randomised, parallel-controlled, single-dose, two-arm pilot study with the primary objective to compare the PK parameters of HLX14 and EU-sourced denosumab after subcutaneous injection, to provide further basis for the study design of part 2. The secondary objective of part 1 is to compare the PD, safety, tolerability, and immunogenicity of HLX14 and EU-sourced denosumab. Part 2 is a double-blind, randomised, parallel-controlled, single-dose, four-arm study with the primary objective to compare the PK similarity of HLX14with US-, EU-, and CN-sourced denosumab ("reference drug").

The secondary objective of part 2 is to compare PD, safety, tolerability, and immunogenicity between HLX14 and the reference drugs. The results of the study suggest that HLX14 had highly similar PK and PD to the reference drugs from different sources, with geometric mean ratios (GMRs) of primaryPK endpoints near 1 and their 90% confidence intervals (CIs) falling entirely in pre-specified equivalence margins of 0.8 to 1.25. Safety, tolerability, and immunogenicity were also comparable.

This study met all of the pre-specified endpoints.