JP2020525498A - 血友病の予防的処置のための第ｉｘ因子およびヒトアルブミンを含む融合タンパク質に関する２１日の投与計画およびその方法 - Google Patents

血友病の予防的処置のための第ｉｘ因子およびヒトアルブミンを含む融合タンパク質に関する２１日の投与計画およびその方法 Download PDF

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JP2020525498A
JP2020525498A JP2019572377A JP2019572377A JP2020525498A JP 2020525498 A JP2020525498 A JP 2020525498A JP 2019572377 A JP2019572377 A JP 2019572377A JP 2019572377 A JP2019572377 A JP 2019572377A JP 2020525498 A JP2020525498 A JP 2020525498A
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fusion protein
fix
per year
days
use according
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JP2020525498A5 (enExample
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ヤンヤン・リー
デブラ・ベンセン−ケネディ
アイリス・ジェイコブズ
クリスティーネ・フォークト
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ツェー・エス・エル・ベーリング・レングナウ・アクチエンゲゼルシャフト
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    • C—CHEMISTRY; METALLURGY
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424—Serine endopeptidases (3.4.21)
    • C12N9/644—Coagulation factor IXa (3.4.21.22)
    • 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
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
    • 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
    • A61K47/64—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/643—Albumins, e.g. HSA, BSA, ovalbumin or a Keyhole Limpet Hemocyanin [KHL]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21022—Coagulation factor IXa (3.4.21.22)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/31—Fusion polypeptide fusions, other than Fc, for prolonged plasma life, e.g. albumin
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/96—Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Toxicology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
JP2019572377A 2017-06-29 2018-06-29 血友病の予防的処置のための第ｉｘ因子およびヒトアルブミンを含む融合タンパク質に関する２１日の投与計画およびその方法 Pending JP2020525498A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762526377P 2017-06-29 2017-06-29
US62/526,377 2017-06-29
PCT/EP2018/067523 WO2019002532A1 (en) 2017-06-29 2018-06-29 21-DAY FUSION PROTEIN DRAFTING COMPRISING IX FACTOR AND HUMAN ALBUMIN FOR THE PROPHYLACTIC TREATMENT OF HEMOPHILIA AND ASSOCIATED METHODS

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JP2020525498A true JP2020525498A (ja) 2020-08-27
JP2020525498A5 JP2020525498A5 (enExample) 2021-07-26

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JP2019572377A Pending JP2020525498A (ja) 2017-06-29 2018-06-29 血友病の予防的処置のための第ｉｘ因子およびヒトアルブミンを含む融合タンパク質に関する２１日の投与計画およびその方法

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Country Link
US (1) US20200115436A1 (enExample)
EP (1) EP3645034B1 (enExample)
JP (1) JP2020525498A (enExample)
KR (1) KR102597725B1 (enExample)
CN (1) CN110799209A (enExample)
AU (1) AU2018294517B2 (enExample)
CA (1) CA3068360A1 (enExample)
DK (1) DK3645034T5 (enExample)
ES (1) ES2963665T3 (enExample)
IL (1) IL271160B2 (enExample)
MX (1) MX2019014651A (enExample)
PL (1) PL3645034T3 (enExample)
RU (1) RU2020103424A (enExample)
SG (1) SG10202111032PA (enExample)
WO (1) WO2019002532A1 (enExample)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017502036A (ja) * 2013-12-23 2017-01-19 シーエスエル、リミテッド 血友病の予防的処置のための第ｉｘ因子を含む融合タンパク質およびその方法

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2275557A1 (en) 2000-04-12 2011-01-19 Human Genome Sciences, Inc. Albumin fusion proteins
US7939632B2 (en) 2006-06-14 2011-05-10 Csl Behring Gmbh Proteolytically cleavable fusion proteins with high molar specific activity
AU2010284977A1 (en) * 2009-08-20 2012-03-29 Csl Behring Gmbh Albumin fused coagulation factors for non-intravenous administration in the therapy and prophylactic treatment of bleeding disorders
NZ605348A (en) * 2010-07-09 2015-01-30 Biogen Idec Hemophilia Inc Factor ix polypeptides and methods of use thereof
TWI810729B (zh) * 2012-09-25 2023-08-01 美商百歐維拉提夫治療公司 Ｆｉｘ多肽的應用
WO2015154139A1 (en) * 2014-04-11 2015-10-15 Csl Limited Half-life extended factor fviia protein for prevention and treatment of bleeding and dosing regimens therefor

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017502036A (ja) * 2013-12-23 2017-01-19 シーエスエル、リミテッド 血友病の予防的処置のための第ｉｘ因子を含む融合タンパク質およびその方法

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Publication number Publication date
IL271160B1 (en) 2025-01-01
PL3645034T3 (pl) 2024-09-02
AU2018294517B2 (en) 2024-09-26
KR20200019749A (ko) 2020-02-24
AU2018294517A1 (en) 2020-01-30
WO2019002532A1 (en) 2019-01-03
MX2019014651A (es) 2020-02-07
ES2963665T3 (es) 2024-04-01
CA3068360A1 (en) 2019-01-03
US20200115436A1 (en) 2020-04-16
KR102597725B1 (ko) 2023-11-06
IL271160A (en) 2020-01-30
DK3645034T5 (da) 2024-08-26
DK3645034T3 (da) 2023-11-20
RU2020103424A3 (enExample) 2021-11-12
IL271160B2 (en) 2025-05-01
SG10202111032PA (en) 2021-11-29
EP3645034B1 (en) 2023-08-30
EP3645034A1 (en) 2020-05-06
CN110799209A (zh) 2020-02-14
RU2020103424A (ru) 2021-07-29

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