MX2019001925A - Proteina de fusion del factor viii de la coagulacion sanguinea humana altamente glicosilada y metodo de fabricacion y aplicacion del mismo. - Google Patents

Proteina de fusion del factor viii de la coagulacion sanguinea humana altamente glicosilada y metodo de fabricacion y aplicacion del mismo.

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Publication number
MX2019001925A
MX2019001925A MX2019001925A MX2019001925A MX2019001925A MX 2019001925 A MX2019001925 A MX 2019001925A MX 2019001925 A MX2019001925 A MX 2019001925A MX 2019001925 A MX2019001925 A MX 2019001925A MX 2019001925 A MX2019001925 A MX 2019001925A
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MX
Mexico
Prior art keywords
fusion protein
manufacturing
application
factor viii
same
Prior art date
Application number
MX2019001925A
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English (en)
Inventor
Gao Jie
Wang Wenwen
Liu Bin
Zhu Wenchen
Li Yuanli
Zhu Chenggong
Gao Yongjuan
Ren Zijia
Zhu Luyan
Sun Naichao
Wang Xiaoshan
Li Zhi
Jiang Ming
Wang Lirui
Wang Shuya
Zhu Songlin
Su Hongsheng
Li Qiang
Wang Qilei
Original Assignee
Ampsource Biopharma Shanghai Inc
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Publication date
Application filed by Ampsource Biopharma Shanghai Inc filed Critical Ampsource Biopharma Shanghai Inc
Publication of MX2019001925A publication Critical patent/MX2019001925A/es

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    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745—Blood coagulation or fibrinolysis factors
    • C07K14/755—Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A61K38/37—Factors VIII
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/65—Peptidic linkers, binders or spacers, e.g. peptidic enzyme-labile linkers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
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    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/59—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g.hCG [human chorionic gonadotropin]; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
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    • C12N15/09—Recombinant DNA-technology
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    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/10—Cells modified by introduction of foreign genetic material
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01K—ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
    • A01K2217/00—Genetically modified animals
    • A01K2217/07—Animals genetically altered by homologous recombination
    • A01K2217/075—Animals genetically altered by homologous recombination inducing loss of function, i.e. knock out
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    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
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    • A01K2227/10—Mammal
    • A01K2227/105—Murine
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01K—ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
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    • A01K2267/035—Animal model for multifactorial diseases
    • A01K2267/0381—Animal model for diseases of the hematopoietic system
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    • C07K2319/00—Fusion polypeptide
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
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    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
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    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/31—Fusion polypeptide fusions, other than Fc, for prolonged plasma life, e.g. albumin
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    • C12N2800/00—Nucleic acids vectors
    • C12N2800/10—Plasmid DNA
    • C12N2800/106—Plasmid DNA for vertebrates
    • C12N2800/107—Plasmid DNA for vertebrates for mammalian

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Abstract

Una proteína de fusión de factor VIII (FVIII) de la coagulación sanguínea humana altamente glicosilada y método de fabricación y aplicación del mismo. La proteína de fusión comprende, desde la N-terminal a la C-terminal, un humano (FVIII), un conector peptídico flexible, al menos una unidad rígida de un péptido carboxil terminal de la subunidad ß de gonadotropina coriónica humana y una parte de vida media que se extiende (seleccionada preferentemente de una variante de lgG Fc humana). La proteína de fusión tiene un nivel similar de actividad biológica como un recombinante (FVIII) y una vida media in vivo prolongada, de este modo, se mejora la farmacocinética y la eficacia del fármaco.
MX2019001925A 2016-08-19 2016-11-16 Proteina de fusion del factor viii de la coagulacion sanguinea humana altamente glicosilada y metodo de fabricacion y aplicacion del mismo. MX2019001925A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201610692838.0A CN106279437B (zh) 2016-08-19 2016-08-19 高糖基化人凝血因子viii融合蛋白及其制备方法与用途
PCT/CN2016/106010 WO2018032637A1 (zh) 2016-08-19 2016-11-16 高糖基化人凝血因子viii融合蛋白及其制备方法与用途

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MX2019001925A true MX2019001925A (es) 2019-10-02

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MX2019001925A MX2019001925A (es) 2016-08-19 2016-11-16 Proteina de fusion del factor viii de la coagulacion sanguinea humana altamente glicosilada y metodo de fabricacion y aplicacion del mismo.

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US (1) US11471513B2 (es)
JP (1) JP6923115B2 (es)
KR (1) KR102276157B1 (es)
CN (1) CN106279437B (es)
GB (1) GB2568624B (es)
MX (1) MX2019001925A (es)
RU (1) RU2722374C1 (es)
WO (1) WO2018032637A1 (es)

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CN106279437B (zh) 2016-08-19 2017-10-31 安源医药科技（上海）有限公司 高糖基化人凝血因子viii融合蛋白及其制备方法与用途
CN107759694B (zh) * 2016-08-19 2023-01-13 安源医药科技（上海）有限公司 双特异性抗体及其制备方法与用途
US11123438B2 (en) 2016-08-19 2021-09-21 Ampsource Biopharma Shanghai Inc. Linker peptide for constructing fusion protein
CN106256835A (zh) * 2016-08-19 2016-12-28 安源医药科技（上海）有限公司 高糖基化人生长激素融合蛋白及其制备方法与用途
CN107337727A (zh) * 2017-08-03 2017-11-10 国药集团武汉血液制品有限公司 一种血源性人凝血因子ⅷ制备方法
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CN108191971B (zh) * 2018-01-02 2022-02-22 汇海(苏州)生物技术有限公司 重组人金属硫蛋白Ⅲα片段纯品的制备方法
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WO2019219048A1 (zh) * 2018-05-18 2019-11-21 北京辅仁瑞辉生物医药研究院有限公司 具有延长半衰期的融合多肽缀合物
CN113105562B (zh) * 2018-09-26 2023-12-01 安源医药科技（上海）有限公司 突变型单链人凝血因子viii在制备融合蛋白中的应用
KR20220004148A (ko) * 2019-05-03 2022-01-11 라니 테라퓨틱스, 엘엘씨 삼킬 수 있는 약물 전달 장치를 사용하여 장관 조직으로 전달하기 위한 응고인자 제제
CN112138149A (zh) * 2019-06-28 2020-12-29 北京基科晟斯医药科技有限公司 重组凝血因子viii制剂
CN113461827A (zh) * 2020-03-31 2021-10-01 安源医药科技（上海）有限公司 高效分离纯化重组人凝血因子VIII Fc融合蛋白的方法
US11981718B2 (en) 2020-05-27 2024-05-14 Ampsource Biopharma Shanghai Inc. Dual-function protein for lipid and blood glucose regulation
CN117337307A (zh) * 2022-05-25 2024-01-02 江苏晟斯生物制药有限公司 具有延长的半衰期的fviii融合蛋白缀合物及其应用
CN116768979B (zh) * 2022-07-06 2025-04-29 华兰基因工程有限公司 一种重组人促卵泡生成素CTP-Fc融合蛋白及制备方法
CN116036244B (zh) * 2023-02-24 2023-09-19 北京基科晟斯医药科技有限公司 培重组人凝血因子VIII-Fc融合蛋白用于治疗含抑制物的血友病A的用途

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