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1. (WO2018032787) HIGHLY GLYCOSYLATED HUMAN GROWTH HORMONE FUSION PROTEIN, AND MANUFACTURING METHOD AND APPLICATION OF SAME
Latest bibliographic data on file with the International Bureau    Submit observation

Pub. No.: WO/2018/032787 International Application No.: PCT/CN2017/079873
Publication Date: 22.02.2018 International Filing Date: 10.04.2017
IPC:
C07K 19/00 (2006.01) ,C12N 15/62 (2006.01) ,A61K 38/27 (2006.01) ,A61P 5/00 (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
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
22
Hormones
27
Growth hormone (GH) (Somatotropin)
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
5
Drugs for disorders of the endocrine system
Applicants: AMPSOURCE BIOPHARMA INC.[CN/CN]; No.3, Lane 908, Ziping Road, Pudong New Area Shanghai 201318, CN
Inventors: LI, Qiang; CN
CHEN, Si; CN
ZHENG, Yuncheng; CN
LI, Zirui; CN
MA, Xinlu; CN
Priority Data:
201610694877.419.08.2016CN
201710202564.730.03.2017CN
Title (EN) HIGHLY GLYCOSYLATED HUMAN GROWTH HORMONE FUSION PROTEIN, AND MANUFACTURING METHOD AND APPLICATION OF SAME
(FR) PROTÉINE DE FUSION D'HORMONE DE CROISSANCE HUMAINE HAUTEMENT GLYCOSYLÉE, SON PROCÉDÉ DE FABRICATION ET SON APPLICATION
(ZH) 高糖基化人生长激素融合蛋白及其制备方法与用途
Abstract:
(EN) A highly glycosylated human growth hormone fusion protein, comprising, from the N-terminus to the C-terminus, of a human growth hormone (hGH), a flexible peptide linker (L), and a human chorionic gonadotropin β-subunit carboxy-terminal rigid peptide (CTP), and an Fc fragment of a human immunoglobulin. Further provided is a highly efficient manufacturing method of the fusion protein. The fusion protein has improved in vivo pharmaceutical efficacy and extended circulation half-life in vivo when compared to a recombinant hGH, greatly reducing administering frequency and improving bioavailability of a drug. The fusion protein also has a simple and highly efficient manufacturing process.
(FR) L'invention concerne une protéine de fusion d'hormone de croissance humaine hautement glycosylée, comprenant, de l'extrémité N-terminale à l'extrémité C-terminale, une hormone de croissance humaine (hGH), un lieur peptidique flexible (L), et un peptide rigide carboxy-terminal (CTP) de sous-unité bêta de la gonadotrophine chorionique humaine (CTP), et un fragment Fc d'une immunoglobuline humaine. L'invention concerne en outre un procédé de fabrication hautement efficace de la protéine de fusion. La protéine de fusion présente une efficacité pharmaceutique améliorée in vivo et une demi-vie de circulation étendue in vivo par comparaison avec une hGH recombinante, réduisant fortement la fréquence d'administration et améliorant la biodisponibilité d'un médicament. La protéine de fusion présente également un processus de fabrication simple et très efficace.
(ZH) 一种高糖基化人生长激素融合蛋白,其从N端到C端依次含有人生长激素(hGH)、柔性肽接头(L)、至少一个人绒毛膜促性腺激素β-亚基羧基末端刚性肽(CTP)和人免疫球蛋白Fc片段。一种高效制备上述融合蛋白的方法。上述融合蛋白比重组hGH具有更优的体内药效,延长的体内循环半衰期,给药频率大大降低且生物利用度提高;同时其生产过程也更简单、高效。
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)