ES2833099T3 - Preparación de disolución estabilizada de una proteína de fusión de un anticuerpo de GLP-1R farmacéutica - Google Patents

Preparación de disolución estabilizada de una proteína de fusión de un anticuerpo de GLP-1R farmacéutica Download PDF

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Publication number
ES2833099T3
ES2833099T3 ES16748688T ES16748688T ES2833099T3 ES 2833099 T3 ES2833099 T3 ES 2833099T3 ES 16748688 T ES16748688 T ES 16748688T ES 16748688 T ES16748688 T ES 16748688T ES 2833099 T3 ES2833099 T3 ES 2833099T3
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Prior art keywords
glp
fusion protein
antibody
stable solution
formulation
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Active
Application number
ES16748688T
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English (en)
Spanish (es)
Inventor
Cheng Zhang
Hua Zhang
Kesuo Fan
Yong Guo
Shuqian Jing
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Gmax Biopharm LLC
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Gmax Biopharm LLC
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/26Glucagons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12Antidiarrhoeals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/04Anorexiants; Antiobesity agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/48Drugs for disorders of the endocrine system of the pancreatic hormones
    • A61P5/50Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575Hormones
    • C07K14/605Glucagons
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2869Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against hormone receptors

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Diabetes (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Emergency Medicine (AREA)
  • Toxicology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Dermatology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
ES16748688T 2015-02-11 2016-02-03 Preparación de disolución estabilizada de una proteína de fusión de un anticuerpo de GLP-1R farmacéutica Active ES2833099T3 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201510071304 2015-02-11
PCT/CN2016/073279 WO2016127887A1 (zh) 2015-02-11 2016-02-03 一种药用glp-1r抗体融合蛋白的稳定溶液制剂

Publications (1)

Publication Number Publication Date
ES2833099T3 true ES2833099T3 (es) 2021-06-14

Family

ID=56615305

Family Applications (1)

Application Number Title Priority Date Filing Date
ES16748688T Active ES2833099T3 (es) 2015-02-11 2016-02-03 Preparación de disolución estabilizada de una proteína de fusión de un anticuerpo de GLP-1R farmacéutica

Country Status (12)

Country Link
US (1) US10485870B2 (enExample)
EP (1) EP3257524B1 (enExample)
JP (1) JP6731953B2 (enExample)
KR (1) KR102568272B1 (enExample)
CN (1) CN105854000A (enExample)
AU (1) AU2016218759B2 (enExample)
CA (1) CA2975633A1 (enExample)
DK (1) DK3257524T3 (enExample)
ES (1) ES2833099T3 (enExample)
PL (1) PL3257524T3 (enExample)
PT (1) PT3257524T (enExample)
WO (1) WO2016127887A1 (enExample)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019060653A1 (en) 2017-09-22 2019-03-28 Regeneron Pharmaceuticals, Inc. GLP-1 RECEPTOR AGONISTS (GLUCAGON-LIKE PEPTIDE 1) AND USES THEREOF
WO2024064842A1 (en) 2022-09-21 2024-03-28 Regeneron Pharmaceuticals, Inc. Methods of treating obesity, diabetes, and liver dysfunction
CN120379686A (zh) * 2022-10-19 2025-07-25 伊莱利利公司 含防腐剂的gip/glp激动剂组合物

Family Cites Families (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9409496D0 (en) 1994-05-12 1994-06-29 London Health Ass Method for improving glycaemic control in diabetes
US6277819B1 (en) 1996-08-30 2001-08-21 Eli Lilly And Company Use of GLP-1 or analogs in treatment of myocardial infarction
US6006753A (en) 1996-08-30 1999-12-28 Eli Lilly And Company Use of GLP-1 or analogs to abolish catabolic changes after surgery
UA65549C2 (uk) 1996-11-05 2004-04-15 Елі Ліллі Енд Компані Спосіб регулювання ожиріння шляхом периферійного введення аналогів та похідних glp-1 (варіанти) та фармацевтична композиція
SE9802080D0 (sv) 1998-06-11 1998-06-11 Hellstroem Pharmaceutical composition for the treatment of functional dyspepsia and/or irritable bowel syndrome and new use of substances therein
US5899883A (en) 1998-07-08 1999-05-04 Jinq Shing Chern Safety syringe
JP2002523333A (ja) 1998-07-31 2002-07-30 ノボ ノルディスク アクティーゼルスカブ Ii型糖尿病を予防するためのglp−1及び類似体の利用
MY155270A (en) 1998-09-24 2015-09-30 Lilly Co Eli Use of glp-1 or analogs in treatment of stroke
EP1329224A4 (en) 2000-09-01 2004-04-14 Chugai Pharmaceutical Co Ltd PREPARATIONS OF STABILIZED SOLUTIONS OVER A LONG PERIOD OF TIME
DK1355942T3 (da) 2000-12-07 2008-11-17 Lilly Co Eli GLP-1-fusionsproteiner
CA2589800A1 (en) 2004-12-02 2006-06-08 Domantis Limited Bispecific domain antibodies targeting serum albumin and glp-1 or pyy
EA011166B1 (ru) 2004-12-22 2009-02-27 Эли Лилли Энд Компани Композиции слитых белков-аналогов glp-1
US20060275288A1 (en) 2005-01-20 2006-12-07 Grihalde Nelson D GLP-1 receptor agonist and allosteric modulator monoclonal antibodies and uses thereof
ES2397289T3 (es) 2005-09-22 2013-03-06 Biocompatibles Uk Ltd. Polipéptidos de fusión de GLP-1 (péptido 1 de tipo glucagón) con resistencia a peptidasa incrementada
US20090098130A1 (en) 2007-01-05 2009-04-16 Bradshaw Curt W Glucagon-like protein-1 receptor (glp-1r) agonist compounds
EA201070121A1 (ru) * 2007-07-10 2010-06-30 Эли Лилли Энд Компани Лекарственная форма, содержащая слитый белок glp-1-fc
US20090021453A1 (en) 2007-07-19 2009-01-22 Zachary Smith Fashion accessory including alternating light emitting and non-light emitting elements of consistent lengths
JP2011503000A (ja) 2007-11-02 2011-01-27 セントコア・オーソ・バイオテツク・インコーポレーテツド 半合成GLP−1ペプチド−Fc融合コンストラクト、その方法及び使用
PE20091174A1 (es) * 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
EP2259802A1 (en) 2008-03-31 2010-12-15 Glaxo Group Limited Drug fusions and conjugates
US8389689B2 (en) 2009-10-28 2013-03-05 Janssen Biotech, Inc. Anti-GLP-1R antibodies and their uses
WO2011060922A1 (en) * 2009-11-17 2011-05-26 Ipsen Pharma S.A.S. Formulation for hgh and rhigf-1 combination
CN102961745B (zh) 2012-09-27 2015-02-18 苏州康聚生物科技有限公司 抗体组合物制剂及其应用
CN104371019B (zh) * 2013-08-13 2019-09-10 鸿运华宁(杭州)生物医药有限公司 一种能与glp-1r特异性结合的抗体及其与glp-1的融合蛋白质

Also Published As

Publication number Publication date
KR102568272B1 (ko) 2023-08-21
KR20170113585A (ko) 2017-10-12
US20180000934A1 (en) 2018-01-04
JP2018508571A (ja) 2018-03-29
US10485870B2 (en) 2019-11-26
CN105854000A (zh) 2016-08-17
PT3257524T (pt) 2020-11-27
EP3257524A4 (en) 2018-09-05
EP3257524A1 (en) 2017-12-20
AU2016218759A1 (en) 2017-09-21
EP3257524B1 (en) 2020-08-26
JP6731953B2 (ja) 2020-07-29
CA2975633A1 (en) 2016-08-18
WO2016127887A1 (zh) 2016-08-18
DK3257524T3 (da) 2020-11-23
PL3257524T3 (pl) 2021-03-08
AU2016218759B2 (en) 2021-11-25

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