Highly glycosylated human blood-clotting factor VIII fusion protein, and manufacturing method and application of same

US11471513B2 · kind B2 · utility

Assignees

• AMPSOURCE BIOPHARMA SHANGHAI INC. · CN
• Furen Pharmaceutical Group Co., Ltd · CN
• Pharmab, Inc. · CN
• Kaifeng Pharmaceutical (Group) Co., Ltd. · CN

Inventors

• Qiang Li · Beijing, CN
• Wenchen Zhu · Zhengzhou, CN
• Yuanli Li · Chongqing, CN
• Chenggong Zhu · Zhoukou City, CN
• Yongjuan Gao · Shanghai, CN
• Zijia Ren · Kaifeng, CN
• Luyan Zhu · Kaifeng, CN
• Naichao Sun · Shanghai, CN
• Xiaoshan Wang · Gaozhou City, CN
• Bin Liu · Fishers, US
• Zhi Li · Nanhu, CN
• Wenwen Wang · Beijing, CN
• Ming Jiang · Beijing, CN
• Qilei Wang · Lo Wu, CN
• Lirui Wang · Kaifeng, CN
• Shuya Wang · Kaifeng, CN
• Songlin Zhu · Zhengzhou, CN
• Jie Gao · Beijing, CN
• Hongsheng Su · Beaconsfield, CA

Key dates

• Filing date: Nov 16, 2016
• Grant date: Oct 18, 2022
• Expiry date: Sep 9, 2038

Classification

• Technology area (CPC C): Chemistry; Metallurgy
• CPC primary: C07K2319/00
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

A highly glycosylated human blood-clotting factor VIII (FVIII) fusion protein, and a manufacturing method and application of same. The fusion protein comprises, from the N-terminus to the C-terminus, a human (FVIII), a flexible peptide connector, at least one rigid unit of a human chorionic gonadotropin β-subunit carboxyl terminal peptide, and a half-life extending portion (preferentially selected from a human IgG Fc variant). The fusion protein has a similar level of biological activity as a recombinant (FVIII) and an extended in vivo half-life, thereby improving pharmacokinetics and drug efficacy.