Generon Receives Special Protocol Assessment For Global Phase III Trial Of F-627 In Chemotherapy-Induced Neutropenia

SHANGHAI--(BUSINESS WIRE)--Generon Corporation, an innovative biopharmaceutical company in China developing novel biological therapeutics, today announced it has reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) regarding the second pivotal global Phase III study design of F-627. F-627 (Benegrastim) is a recombinant human granulocyte colony-stimulating factor (rhG-CSF) dimer with a best-in-class potential to manage chemotherapy-induced neutropenia (CIN) in cancer patients. The SPA provides a binding agreement with the FDA’s review division that the Phase III trial can adequately address objectives in support of a U.S. regulatory submission for approval of F-627 for the treatment of cancer patients with CIN. Final marketing approval depends upon the efficacy results, safety profile and an evaluation of the risk/benefit of treatment demonstrated in the Phase III clinical trial.

“Obtaining the FDA’s agreement on the F-627 Phase III trial design, endpoints, patient population and statistical approach is a significant accomplishment as it presents a clear path forward,” said Dr. David Lacey, Chairman of Generon’s Scientific Advisory Board. “Collaborative discussions with the FDA led to a positive outcome with this SPA that reduces regulatory risk for this product,” he continued.

The current phase III study is a two-arm, randomized (1:1), open label, active controlled study designed to assess the efficacy of F-627 in breast cancer patients receiving chemotherapy in trial centers in multiple countries. Patients receive either a dose of F-627 or a standard dose of the comparator after each chemotherapy cycle.

The management executives of E-fan Pharmaceuticals congratulated Generon’s team on this success and emphasized their continued confidence in Generon’s ability to pursue F-627’s clinical development. Dr. Xiao Qiang Yan, Chairman and CEO of Generon, commented, “Reaching this agreement with the FDA and achieving an SPA was a major goal for Generon this year and is a significant step towards our mission of Innovating for Life. Generon is committed to bringing the best-in-class rhG-CSF to patients world-wide.” The first pivotal phase III study of F-627 is a placebo-controlled study conducted in multiple countries. The patient enrollment is completed.

Chemotherapy-induced Neutropenia (CIN)

CIN occurs commonly during current cancer treatments involving cytotoxic chemotherapy. In the U.S. alone, it is estimated that approximately 1.7 million cancer patients receive chemotherapy treatment, which amounts to a total of 7.5 million chemotherapy cycles performed annually with approximately 5.0 million chemotherapy cycles involving CIN. The global CIN market is estimated to be at $7.0 billion with about >85% of patients still on first-generation of rhG-CSFs, and less than 15% of patients using second-generation rhG-CSFs.

About F-627

F-627 (benegrastim) is under development for the treatment of CIN in cancer patients. F-627 is a recombinant fusion protein containing G-CSF and human IgG2-Fc and is expressed in Chinese Hamster Ovary (CHO) cells. F-627 has an immunoglobulin-like structure. It consists of two G-CSF molecules at the N-terminal of Fc fragments (a G-CSF dimer). G-CSF is a growth factor acting on the neutrophilic lineage in the hematopoietic system. G-CSF binds to specific G-CSF receptors (G-CSFR) on the cell surface and stimulates differentiation, proliferation, and activation of neutrophilic granulocytes. F-627 has showed stronger bioactivities than the monomeric rhG-CSFs in vitro and in vivo.

About Generon Corporation

Generon (Shanghai) Corporation (Generon) is a privately held and leading biotechnology company located in Shanghai, China focusing on the development of innovative biological therapies for patients worldwide.