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1. (WO2018032786) HUMAN COAGULATION FACTOR IX (FIX) FUSION PROTEIN, PREPARATION METHOD THEREFOR, AND USE THEREOF
Latest bibliographic data on file with the International Bureau    Submit observation

Pub. No.: WO/2018/032786 International Application No.: PCT/CN2017/079872
Publication Date: 22.02.2018 International Filing Date: 10.04.2017
IPC:
C07K 19/00 (2006.01) ,C12N 15/62 (2006.01) ,C12N 15/63 (2006.01) ,C12N 15/85 (2006.01) ,C12N 5/10 (2006.01) ,A61K 38/36 (2006.01) ,A61P 7/04 (2006.01)
C CHEMISTRY; METALLURGY
07
ORGANIC CHEMISTRY
K
PEPTIDES
19
Hybrid peptides
C CHEMISTRY; METALLURGY
12
BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
N
MICRO-ORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICRO-ORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
15
Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
09
Recombinant DNA-technology
11
DNA or RNA fragments; Modified forms thereof
62
DNA sequences coding for fusion proteins
C CHEMISTRY; METALLURGY
12
BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
N
MICRO-ORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICRO-ORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
15
Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
09
Recombinant DNA-technology
63
Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
C CHEMISTRY; METALLURGY
12
BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
N
MICRO-ORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICRO-ORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
15
Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
09
Recombinant DNA-technology
63
Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
79
Vectors or expression systems specially adapted for eukaryotic hosts
85
for animal cells
C CHEMISTRY; METALLURGY
12
BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
N
MICRO-ORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICRO-ORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
5
Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
10
Cells modified by introduction of foreign genetic material, e.g. virus-transformed cells
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38
Medicinal preparations containing peptides
16
Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17
from animals; from humans
36
Blood coagulation or fibrinolysis factors
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
7
Drugs for disorders of the blood or the extracellular fluid
04
Antihaemorrhagics; Procoagulants; Haemostatatic agents; Antifibrinolytic agents
Applicants: AMPSOURCE BIOPHARMA INC.[CN/CN]; Room 106, No. 518, BiBo Road Pudong New Area Shanghai 201203, CN
PHARMAB, INC.[CN/CN]; Room 315, No. 518, BiBo Road Pudong New Area Shanghai 201203, CN
Inventors: GAO, YongJuan; CN
CHEN, Si; CN
LI, Zirui; CN
TU, Xiaoping; CN
SUN, Bill Nai-chau; CN
LI, Qiang; CN
Priority Data:
201610694914.119.08.2016CN
Title (EN) HUMAN COAGULATION FACTOR IX (FIX) FUSION PROTEIN, PREPARATION METHOD THEREFOR, AND USE THEREOF
(FR) PROTÉINE DE FUSION DU FACTEUR IX DE COAGULATION HUMAIN (FIX), SON PROCÉDÉ DE PRÉPARATION ET SON UTILISATION
(ZH) 人凝血因子IX融合蛋白及其制备方法与用途
Abstract:
(EN) 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.
(FR) L'invention concerne une protéine de fusion du facteur IX de coagulation humain (FIX) hyperglycosylé, son procédé de préparation et son utilisation. La protéine de fusion comprend séquentiellement, de l'extrémité N-terminale à C-terminale, un FIX humain, un lieur peptidique flexible, au moins une unité rigide de peptide carboxy-terminal de sous-unité bêta de gonadotrophine chorionique humaine, et une fraction d'extension de demi-vie. La protéine de fusion a une activité biologique similaire à celle du FIX recombinant, une demi-vie d'activité in vivo étendue et une immunogénicité réduite, de manière à améliorer la pharmacocinétique et la pharmacodynamique.
(ZH) 一种高糖基化的重组人凝血因子IX(FIX)融合蛋白、其制备方法及用途。所述融合蛋白从N端到C端依次包含人FIX、柔性肽接头、至少1个人绒毛膜促性腺激素β亚基羧基末端肽刚性单元和延长半衰期部分。该融合蛋白具有与重组FIX类似的生物学活性及延长的体内活性半衰期,降低的免疫原性,从而改善药代动力学和药效。
Designated States: AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW
African Regional Intellectual Property Organization (ARIPO) (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Office (AM, AZ, BY, KG, KZ, RU, TJ, TM)
European Patent Office (EPO) (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG)
Publication Language: Chinese (ZH)
Filing Language: Chinese (ZH)