Generon commences F-627 Phase II trial in breast cancer

Generon (Shanghai) Corporation Ltd. today announced the initiation of a Phase II clinical trial for F-627 after US FDA regulatory clearance. The current study is a Phase II, randomized, multicenter, open-label, active-controlled trial of F-627 in women with breast cancer receiving myelotoxic chemotherapy. The clinical trial will enroll approximately 200 patients. The clinical trial will be conducted at approximately 35 clinical centers in North America and Europe. The primary objective of this study is to evaluate 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.

Generon completed a phase I study in healthy volunteers in Australia in 2011. The favorable safety and pharmacokinetics and pharmacodynamics properties of F-627 were demonstrated in this Phase I study. The company decided to further test the efficacy and safety of F-627 in cancer patients after chemotherapy in a global multicenter trial.

In reaction to FDA's green light to F-627 moving into Phase II in the US, Dr. Yu-Liang Huang, the CEO of Generon (Shanghai) Corporation, expressed the following thought: "This is the first innovative biologic drug developed by a Chinese biotech company entering global clinical development. We are very pleased with FDA's decision allowing us to conduct the Phase II trial in the US. This is a significant milestone for our science and business. We remain focused on our mission to innovate for life and to serve global patients."