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: All clinical trials have been completed and the Biologics License Application (BLA) was submitted to the US Food & Drug Administration (FDA) in March 2021.  Evive is working towards submitting a Marketing Authorization Application to the European Medicines Agency (EMA) and a New Drug Application to China’s National Medical Products Administration (NMPA), and other national regulatory agencies in accordance with regulatory requirements as well.

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:

China’s National Medical Products Administration (NMPA) approved the investigational new drug (IND) application for F-899. Other DiKineTM and long-acting multi-specific platform products are in pre-clinical development stage.

Ryzneuta™ (F-627)

Introduction

Ryzneuta™ (F-627) 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, and the BLA has been submitted to US FDA in March 2021. Ryzneuta™ is a recombinant fusion protein containing human granulocyte colony-stimulating factor (G-CSF) and the crystallizable fragment domain of human IgG2 (Fc). Ryzneuta™ is expressed in Chinese Hamster Ovary (CHO) cells. Ryzneuta™ 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. Evive 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.