KR20220125289A - Fgf-21 접합체 제제 - Google Patents

Fgf-21 접합체 제제 Download PDF

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Publication number
KR20220125289A
KR20220125289A KR1020227026861A KR20227026861A KR20220125289A KR 20220125289 A KR20220125289 A KR 20220125289A KR 1020227026861 A KR1020227026861 A KR 1020227026861A KR 20227026861 A KR20227026861 A KR 20227026861A KR 20220125289 A KR20220125289 A KR 20220125289A
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South Korea
Prior art keywords
fgf
histidine
concentration
sucrose
conjugate
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Pending
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KR1020227026861A
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English (en)
Korean (ko)
Inventor
토마스 팜
메르나즈 코스라비
산케트 파트케
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브리스톨-마이어스 스큅 컴퍼니
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Publication of KR20220125289A publication Critical patent/KR20220125289A/ko
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    • 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
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays or needleless injectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • 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
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/1825—Fibroblast growth factor [FGF]
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/54—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 organic compound
    • A61K47/542—Carboxylic acids, e.g. a fatty acid or an amino acid
    • 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
    • A61K47/54—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 organic compound
    • A61K47/547—Chelates, e.g. Gd-DOTA or Zinc-amino acid chelates; Chelate-forming compounds, e.g. DOTA or ethylenediamine being covalently linked or complexed to the pharmacologically- or therapeutically-active agent
    • 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
    • A61K47/56—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • 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
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Dermatology (AREA)
  • Immunology (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
KR1020227026861A 2020-01-08 2021-01-07 Fgf-21 접합체 제제 Pending KR20220125289A (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202062958580P 2020-01-08 2020-01-08
US62/958,580 2020-01-08
PCT/US2021/012530 WO2021142143A1 (en) 2020-01-08 2021-01-07 Fgf-21 conjugate formulations

Publications (1)

Publication Number Publication Date
KR20220125289A true KR20220125289A (ko) 2022-09-14

Family

ID=74572842

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020227026861A Pending KR20220125289A (ko) 2020-01-08 2021-01-07 Fgf-21 접합체 제제

Country Status (13)

Country Link
US (2) US20230346957A1 (https=)
EP (1) EP4087612A1 (https=)
JP (1) JP7600244B2 (https=)
KR (1) KR20220125289A (https=)
CN (1) CN115243725A (https=)
AR (1) AR122359A1 (https=)
AU (1) AU2021205912A1 (https=)
BR (1) BR112022013172A2 (https=)
CA (1) CA3167062A1 (https=)
IL (1) IL294534A (https=)
MX (1) MX2022008336A (https=)
TW (1) TW202140074A (https=)
WO (1) WO2021142143A1 (https=)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2023538533A (ja) * 2020-08-07 2023-09-08 ブリストル－マイヤーズ スクイブ カンパニー 線維症の処置のための、ｃｃｒ２／５拮抗剤と組み合わせたｆｇｆ２１
US20240123031A1 (en) * 2020-11-25 2024-04-18 Bristol-Myers Squibb Company Methods of treating liver diseases
WO2024153195A1 (en) * 2023-01-18 2024-07-25 Beijing Ql Biopharmaceutical Co., Ltd. Liquid pharmaceutical compositions of fusion polypeptides and methods of uses thereof

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US4179337A (en) 1973-07-20 1979-12-18 Davis Frank F Non-immunogenic polypeptides
US5252714A (en) 1990-11-28 1993-10-12 The University Of Alabama In Huntsville Preparation and use of polyethylene glycol propionaldehyde
US5643575A (en) 1993-10-27 1997-07-01 Enzon, Inc. Non-antigenic branched polymer conjugates
US7459540B1 (en) 1999-09-07 2008-12-02 Amgen Inc. Fibroblast growth factor-like polypeptides
WO2001032678A1 (en) 1999-11-05 2001-05-10 Smithkline Beecham Corporation sbgFGF-19a
EP2163626A1 (en) 1999-11-18 2010-03-17 Novartis Vaccines and Diagnostics, Inc. Human FGF-21 gene and gene expression products
US6716626B1 (en) 1999-11-18 2004-04-06 Chiron Corporation Human FGF-21 nucleic acids
US20040259780A1 (en) 2001-07-30 2004-12-23 Glasebrook Andrew Lawrence Method for treating diabetes and obesity
US20050176631A1 (en) 2002-01-15 2005-08-11 Heuer Josef G. Method for reducing morbidity and mortality in critically ill patients
ATE385806T1 (de) 2003-06-12 2008-03-15 Lilly Co Eli Fusionsproteine
EP2270163A1 (en) 2003-12-10 2011-01-05 Eli Lilly and Company Muteins of fibroblast growth factor 21
US20090111742A1 (en) 2004-01-26 2009-04-30 Alexei Kharitonenkov Use of fgf-21 and thiazolidinedione for treating type 2 diabetes
JP2007531715A (ja) 2004-03-17 2007-11-08 イーライ リリー アンド カンパニー グリコール結合ｆｇｆ−２１化合物
EP2194064A1 (en) 2004-05-13 2010-06-09 Eli Lilly & Company FGF-21 fusion proteins
US7622445B2 (en) 2004-09-02 2009-11-24 Eli Lilly And Company Muteins of fibroblast growth factor 21
KR100854198B1 (ko) 2004-09-02 2008-08-26 일라이 릴리 앤드 캄파니 섬유아세포 성장 인자 21의 뮤테인
WO2006050247A2 (en) 2004-10-29 2006-05-11 Neose Technologies, Inc. Remodeling and glycopegylation of fibroblast growth factor (fgf)
US7655627B2 (en) 2004-12-14 2010-02-02 Eli Lilly And Company Muteins of fibroblast growth factor 21
EP1846019A2 (en) 2005-01-21 2007-10-24 Eli Lilly And Company Method for treating cardiovascular disease
CN107501407B (zh) 2007-03-30 2022-03-18 Ambrx公司 经修饰fgf-21多肽和其用途
US8034770B2 (en) 2008-06-04 2011-10-11 Amgen Inc. FGF21 polypeptides comprising two or more mutations
CA2739615C (en) 2008-10-10 2017-12-05 Amgen Inc. Fgf21 mutants comprising polyethylene glycol and uses thereof
WO2011154349A2 (en) 2010-06-08 2011-12-15 Novo Nordisk A/S Fgf21 analogues and derivatives
JP2014500248A (ja) * 2010-11-05 2014-01-09 コヴェックス・テクノロジーズ・アイルランド・リミテッド 抗糖尿病化合物
US9023791B2 (en) 2010-11-19 2015-05-05 Novartis Ag Fibroblast growth factor 21 mutations
AR087973A1 (es) 2011-10-04 2014-04-30 Lilly Co Eli Variantes del factor 21 del crecimiento de fibroblastos
TWI513705B (zh) 2012-06-11 2015-12-21 Lilly Co Eli 纖維母細胞生長因子２１蛋白質
US9434788B2 (en) 2012-07-11 2016-09-06 The United States Of America, As Represented By The Secretary Of Agriculture Bio-based fiber gums (BFGs) and processes for producing BFGs
US10105447B2 (en) * 2013-03-13 2018-10-23 Elanco Us Inc. Method of treating obesity in a companion animal comprising administering a modified canine leptin polypeptide
CN114805532A (zh) * 2014-10-24 2022-07-29 百时美施贵宝公司 修饰的fgf-21多肽及其用途
KR20250004095A (ko) 2015-04-17 2025-01-07 브리스톨-마이어스 스큅 컴퍼니 항-pd-1 항체 및 또 다른 항체의 조합물을 포함하는 조성물
KR20210027426A (ko) * 2018-07-03 2021-03-10 브리스톨-마이어스 스큅 컴퍼니 Fgf21 제제

Also Published As

Publication number Publication date
MX2022008336A (es) 2022-08-08
EP4087612A1 (en) 2022-11-16
JP2023510268A (ja) 2023-03-13
AU2021205912A1 (en) 2022-07-28
CN115243725A (zh) 2022-10-25
JP7600244B2 (ja) 2024-12-16
IL294534A (en) 2022-09-01
BR112022013172A2 (pt) 2022-09-13
WO2021142143A1 (en) 2021-07-15
AR122359A1 (es) 2022-09-07
TW202140074A (zh) 2021-11-01
US20230346957A1 (en) 2023-11-02
CA3167062A1 (en) 2021-07-15
US20220016211A1 (en) 2022-01-20

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Patent event date: 20220803

Patent event code: PA01051R01D

Comment text: International Patent Application

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