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

Info

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
Authority
ES
Spain
Prior art keywords
glp
fusion protein
antibody
stable solution
formulation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
ES16748688T
Other languages
English (en)
Spanish (es)
Inventor
Cheng Zhang
Hua Zhang
Kesuo Fan
Yong Guo
Shuqian Jing
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Gmax Biopharm LLC
Original Assignee
Gmax Biopharm LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Gmax Biopharm LLC filed Critical Gmax Biopharm LLC
Application granted granted Critical
Publication of ES2833099T3 publication Critical patent/ES2833099T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K38/22—Hormones
    • A61K38/26—Glucagons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • 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
    • A61K47/26—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • 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
    • 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
    • A61P1/12—Antidiarrhoeals
    • 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
    • A61P3/04—Anorexiants; Antiobesity agents
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
    • A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • 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
    • C07K14/575—Hormones
    • C07K14/605—Glucagons
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2869—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against hormone receptors

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (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)
  • Hematology (AREA)
  • Obesity (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Emergency Medicine (AREA)
  • Dermatology (AREA)
  • Toxicology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (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 (11)

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

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MY200364A (en) 2017-09-22 2023-12-21 Regeneron Pharma Glucagon-like peptide 1 receptor agonists and uses thereof
CN120187750A (zh) 2022-09-21 2025-06-20 瑞泽恩制药公司 治疗肥胖、糖尿病和肝功能障碍的方法
KR102942046B1 (ko) * 2022-10-19 2026-03-24 일라이 릴리 앤드 캄파니 보존된 gip/glp 효능제 조성물
WO2026021575A1 (zh) * 2024-07-26 2026-01-29 鸿运华宁（杭州）生物医药有限公司 一种gipr抗体融合蛋白质的药用稳定溶液制剂及其应用

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
US6006753A (en) 1996-08-30 1999-12-28 Eli Lilly And Company Use of GLP-1 or analogs to abolish catabolic changes after surgery
US6277819B1 (en) 1996-08-30 2001-08-21 Eli Lilly And Company Use of GLP-1 or analogs in treatment of myocardial infarction
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
AU5027299A (en) 1998-07-31 2000-02-28 Novo Nordisk A/S Use of glp-1 and analogues for preventing type ii diabetes
MY155270A (en) 1998-09-24 2015-09-30 Lilly Co Eli Use of glp-1 or analogs in treatment of stroke
EP1930024A3 (en) * 2000-09-01 2008-08-06 Chugai Seiyaku Kabushiki Kaisha G-CSF solution formulations having long-term stability
BR0116024A (pt) 2000-12-07 2005-12-13 Lilly Co Eli Proteìna de fusão heteróloga e uso da mesma
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
PL1767545T3 (pl) 2005-09-22 2010-04-30 Biocompatibles Uk Ltd Polipeptydy fuzyjne GLP-1 (glukagonopodobny peptyd-1) o zwiększonej odporności na peptydazy
US20090098130A1 (en) 2007-01-05 2009-04-16 Bradshaw Curt W Glucagon-like protein-1 receptor (glp-1r) agonist compounds
CN101730523A (zh) * 2007-07-10 2010-06-09 伊莱利利公司 GLP-1-Fc融合蛋白质制剂
US20090021453A1 (en) 2007-07-19 2009-01-22 Zachary Smith Fashion accessory including alternating light emitting and non-light emitting elements of consistent lengths
WO2009059278A1 (en) 2007-11-02 2009-05-07 Centocor, Inc. Semi-synthetic glp-1 peptide-fc fusion constructs, methods and uses
PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
KR20100132535A (ko) 2008-03-31 2010-12-17 글락소 그룹 리미티드 약물 융합체 및 컨주게이트
US8389689B2 (en) * 2009-10-28 2013-03-05 Janssen Biotech, Inc. Anti-GLP-1R antibodies and their uses
KR101614983B1 (ko) * 2009-11-17 2016-04-22 입센 파마 에스.에이.에스 Ｈｇｈ 및 ｒｈｉｇｆ―１의 조합물을 위한 제제
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
PT3257524T (pt) 2020-11-27
JP2018508571A (ja) 2018-03-29
AU2016218759A1 (en) 2017-09-21
WO2016127887A1 (zh) 2016-08-18
CA2975633A1 (en) 2016-08-18
KR20170113585A (ko) 2017-10-12
JP6731953B2 (ja) 2020-07-29
KR102568272B1 (ko) 2023-08-21
US10485870B2 (en) 2019-11-26
EP3257524A4 (en) 2018-09-05
EP3257524A1 (en) 2017-12-20
DK3257524T3 (da) 2020-11-23
CN105854000A (zh) 2016-08-17
AU2016218759B2 (en) 2021-11-25
PL3257524T3 (pl) 2021-03-08
US20180000934A1 (en) 2018-01-04
EP3257524B1 (en) 2020-08-26

Similar Documents

Publication Publication Date Title
US9125893B2 (en) Highly concentrated anti-CD40 antibody pharmaceutical preparation
ES2791690T3 (es) Formulaciones liofilizadas
JP7738136B2 (ja) グルカゴン様ペプチド－２（ｇｌｐ－２）類似体の製剤
US12576025B2 (en) Pharmaceutical parenteral composition of dual GLP1/2 agonist
ES2833099T3 (es) Preparación de disolución estabilizada de una proteína de fusión de un anticuerpo de GLP-1R farmacéutica
JP2016523916A (ja) 安定な液体製剤
EP3125928A1 (en) Liquid pharmaceutical composition of adalimumab
ES3019509T3 (en) Pharmaceutical composition of glp-1/glp-2 dual agonists
US10918698B2 (en) Lyophilized pharmaceutical composition of Fc-peptide fusion protein
KR20230121824A (ko) Glp-1/glp-2 이중 효능제의 약학적 조성물
EP3856767A1 (en) Formulations of glucagon-like-peptide-2 (glp-2) analogues
CA2975633C (en) Stable pharmaceutical solution formulation of glp-1r antibody fusion protein
ES2843685T3 (es) Composición farmacéutica líquida de eritropoyetina conjugada
CN121927035A (zh) 一种药用glp-1r抗体融合蛋白的稳定溶液制剂
IL305010A (en) An aqueous preparation of a transgenic protein structure that includes an FC domain
WO2021263040A1 (en) Stable peptibody formulations
JP2023526024A (ja) Ｉｌ－２融合ポリペプチド組成物ならびにその作製及び使用方法