JD Supra6 天
FDA Accepts BLA for Shanghai Henlius Biotech’s and Organon’s HLX14, a Denosumab Biosimilar
The first study was a two-part phase 1 trial in healthy adult males in China. Part 1 was an open-label pilot study, comparing HLX14’s pharmacokinetics with EU-sourced PROLIA after subcutaneous ...