The company has received FDA regulatory clearance for the randomized, multicenter, open-label, active-controlled trial of F-627.
Generon CEO Yu-Liang Huang said, "This is the first innovative biologic drug developed by a Chinese biotech company entering global clinical development."
The trial is expected to enroll 200 patients and to be conducted at 35 clinical centers in North America and Europec.
The primary objective of this study is to analyze the efficacy and safety of various once-per-cycle dosing of F-627 as compared with the standard dosing of Neulasta (pegfilgrastim) in breast cancer patients undergoing myelotoxic chemotherapy.