Recombinant Human Coagulation Factor VIIa for Injection (NL201)

● Project Overview

　　Registration Category: Biological Products for Therapeutic Use, Category 3

　　Indications: Hemophilia

　　R&D Progress: Preclinical Studies

　　Market Outlook: Currently, the only available recombinant factor VIIa on the market is NovoSeven, an imported product that comes with a high price. Given this product’s excellent therapeutic and preventive effects on surgical procedures or invasive bleeding, the market size is expected to exceed 1 billion RMB.

　　 ● Mechanism of action

　　FVIIa is an important molecule in the extrinsic coagulation pathway. By binding to tissue factor, it triggers the conversion of prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin, forming an insoluble clot and thereby exerting a hemostatic effect.

　　 ●Research findings

　　In the NL201 project, the construction and screening of engineered strains have been completed, and a standardized seed bank has been established. Through small-scale trials, key technologies and parameters for the production process have been optimized, particularly addressing the challenges of low recombinant expression levels and high oxidation product formation in FVIIa products, and quality standards have been established.