Pipeline

Our focus on efficiency and quality provides patients with new, safe, and efficacious treatment options quickly. We plan the development of our products to meet regulatory requirements for commercial marketing. We stand by our philosophy: do one thing, do it well.

 

Late Stage Products:

F-627: Once all clinical trials are completed, Evive will submit marketing authorization applications to FDA, EMA, CDE and other national regulatory agencies in accordance with regulatory requirements.

Development Stage Products:

Two Phase IIa trials have been completed with F-652, each demonstrating safety and efficacy in two indications with high unmet medical needs. Further development is planned, based on orphan dug designation recently granted by the FDA. Expansion of the indication is also planned.

Early Stage Products:

F-899 is in preparation for IND filling. A-337 and A-319 are in Phase I clinical study. Other DiKineTM and ITabTM products are in pre-clinical development stage.

F-627 Ryzneuta™

Introduction

Ryzneuta™ is intended to treat chemotherapy-induced neutropenia (CIN) in patients with cancer. Two Phase III head-to-head trials against Neupogen (filgrastim) and Neulasta (peg-filgrastim) have been successfully completed for China and global markets (including the US and Europe) respectively, with regulatory filings to follow soon. F-627 is a recombinant fusion protein containing human granulocyte colony-stimulating factor (G-CSF) and the crystallizable fragment domain of human IgG2 (Fc). F-627 is expressed in Chinese Hamster Ovary (CHO) cells. F-627 exists as a homodimer. G-CSF binds to specific G-CSF receptors (G-CSFR) on the cell surface and influences the survival, proliferation, and differentiation of all cells in the neutrophil lineage, from haemopoietic stem cell through mature neutrophil.

F-652

Introduction

IL-22 is produced by activated immune cells in response to inflammation of infection and primarily acts on epithelial cells and stroma cells through binding to its receptors selectively expressed on the surface of these cell types. Once bound to its receptors, IL-22 promotes proliferation, remodeling, and repair of various tissues and organs to maintain innate host defense mechanisms that control the invasion of pathogens. IL-22 plays a broad role in protecting damages to barrier integrity and tissue homeostasis induced by a variety of pathogens such as viruses, bacteria, and chemicals.

IL-22 still remains a novel target without any drug launched on the market. However, numerous studies have shown the correlation between IL-22 and various inflammatory diseases. Generon is leading research in this field and is one of only two companies worldwide to develop an IL-22 drug through a Phase II clinical trial, along with Genentech (Roche).

Our leading drug in this field, F-652, is an IL-22-Fc fusion protein under development. F-652 is a recombinant fusion protein consisting of a human interleukin 22 (IL-22) moiety and a human IgG2 Fc moiety. F-652 is manufactured in Chinese Hamster Ovary (CHO) cells. It exists as a homodimer. F-652 is a first-in-class biological drug.

Other Early Stage Assets

Bi-specific antibodies generated from Evive’s ITabTM platform simultaneously bind to CD3 molecules on human T cells and to specific tumor antigens, forming a synapsis between a tumor cell and T cells linked by the ITabTM antibodies. The formation of a synapsis leads to activation of T cells, and the release of mediators lysing the tumor cells. The ITabTM antibody can drive the expansion of T cells rendering T cells as serial killers of tumor cells.

A-319 is a bi-specific antibody (BsAb) designed to target CD19 and CD3 (anti-CD19, anti-CD3) and is under development for the treatment of patients with B cell malignancies including ALL, CLL, Lymphoma. A-319 activates the immune system, specifically T cells in a patient, to kill B cells. The China Phase I IND application has been filed with CFDA.