Human coagulation factor IX (FIX) fusion protein, preparation method therefor, and use thereof

US11472863B2 · kind B2 · utility

Assignees

• AMPSOURCE BIOPHARMA SHANGHAI INC. · CN
• Pharmab, Inc. · CN

Inventors

• Yongjuan Gao · Shanghai, CN
• Si Chen · Pearland, US
• Zirui Li · Shanghai, CN
• Xiaoping Tu · Shanghai, CN
• Bill N. C. Sun · Bellaire, US
• Qiang Li · Beijing, CN

Key dates

• Filing date: Apr 10, 2017
• Grant date: Oct 18, 2022
• Expiry date: May 3, 2037

Classification

• Technology area (CPC Y): Emerging Cross-Sectional Technologies
• CPC primary: Y02A50/30
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

A hyperglycosylated recombinant human coagulation factor IX (FIX) fusion protein, a preparation method therefor, and use thereof. The fusion protein sequentially comprises, from N- to C-terminus, a human FIX, a flexible peptide linker, at least one human chorionic gonadotropin β subunit carboxy-terminal peptide rigid unit, and a half-life extending moiety. The fusion protein has a biological activity similar to that of the recombinant FIX, an extended in vivo activity half-life, and reduced immunogenicity, so as to improve pharmacokinetics and pharmacodynamics.