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1. (WO2018032637) HIGHLY GLYCOSYLATED HUMAN BLOOD-CLOTTING FACTOR VIII FUSION PROTEIN, AND MANUFACTURING METHOD AND APPLICATION OF SAME

Pub. No.:    WO/2018/032637    International Application No.:    PCT/CN2016/106010
Publication Date: Fri Feb 23 00:59:59 CET 2018 International Filing Date: Thu Nov 17 00:59:59 CET 2016
IPC: C07K 19/00
C12N 15/62
C12N 15/85
C12N 5/10
A61K 38/37
A61P 7/04
Applicants: AMPSOURCE BIOPHARMA INC.
安源医药科技(上海)有限公司
FUREN PHARMACEUTICAL GROUP CO., LTD.
辅仁药业集团有限公司
PHARMAB, INC.
旭华(上海)生物研发中心有限公司
KAIFENG PHARMACEUTICAL (GROUP) CO., LTD.
开封制药(集团)有限公司
Inventors: LI, Qiang
李强
ZHU, Wenchen
朱文臣
LI, Yuanli
李媛丽
ZHU, Chenggong
朱成功
GAO, Yongjuan
高永娟
REN, Zijia
任子甲
ZHU, Luyan
朱鹿燕
SUN, Naichao
孙乃超
WANG, Xiaoshan
王晓山
LIU, Bin
刘宾
LI, Zhi
李智
WANG, Wenwen
王文文
JIANG, Ming
姜明
WANG, Qilei
王齐磊
WANG, Lirui
王莉蕊
WANG, Shuya
王淑亚
ZHU, Songlin
朱松林
GAO, Jie
高洁
SU, Hongsheng
苏鸿声
Title: HIGHLY GLYCOSYLATED HUMAN BLOOD-CLOTTING FACTOR VIII FUSION PROTEIN, AND MANUFACTURING METHOD AND APPLICATION OF SAME
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.