Long-acting recombinant human follicle-stimulating hormone-Fc fusion protein

US10023624B2 · kind B2 · utility

Assignee

• UnicoHealth Co. Ltd. · CN

Inventors

• Yongmin Hou · 流花街道, CN
• Qiang Li · Beijing, CN
• Maobo Wu · 流花街道, CN
• Sha LIAO · Lexington, US
• Yujie Zhang · Lomita, US
• Zhenqi Xu · 流花街道, CN

Key dates

• Filing date: Aug 22, 2014
• Grant date: Jul 17, 2018
• Expiry date: Aug 22, 2034

Classification

• Technology area (CPC C): Chemistry; Metallurgy
• CPC primary: C07K2319/30
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

Recombinant Fc fusion proteins of human follicle-stimulating hormone (hFSH) with in vivo biological activities comparable to those of human follicle-stimulating hormone are disclosed. A recombinant hFSH-Fc fusion protein comprises β subunit of hFSH (hFSH β), CTP, α subunit of hFSH (hFSH α), a flexible peptide linker, and human IgG2 Fc variant (vIgG2Fc). A method is also disclosed to make such fusion proteins at good expression levels. These recombinant hFSH-Fc fusion proteins of the present disclosure exhibit sufficient biological activities and prolonged plasma half-lives, leading to improved pharmacokinetics and pharmacodynamics. Thus, a lower dosage may be used and/or better or different therapeutic efficacies with less side effects may be achieved. A method for the application of the recombinant hFSH-Fc fusion proteins in the treatment and/or prevention of human infertility is also disclosed.