PL3257524T3 - Stabilny preparat farmaceutyczny w postaci roztworu białka fuzyjnego przeciwciała przeciwko glp-1r - Google Patents

Stabilny preparat farmaceutyczny w postaci roztworu białka fuzyjnego przeciwciała przeciwko glp-1r

Info

Publication number
PL3257524T3
PL3257524T3 PL16748688T PL16748688T PL3257524T3 PL 3257524 T3 PL3257524 T3 PL 3257524T3 PL 16748688 T PL16748688 T PL 16748688T PL 16748688 T PL16748688 T PL 16748688T PL 3257524 T3 PL3257524 T3 PL 3257524T3
Authority
PL
Poland
Prior art keywords
fusion protein
pharmaceutical preparation
antibody against
protein solution
stable pharmaceutical
Prior art date
Application number
PL16748688T
Other languages
English (en)
Inventor
Cheng Zhang
Hua Zhang
Kesuo Fan
Yong Guo
Shuqian Jing
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
Publication of PL3257524T3 publication Critical patent/PL3257524T3/pl

Links

Classifications

    • 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
    • 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
    • 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 [IG], e.g. monoclonal or polyclonal antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2869Immunoglobulins [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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (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)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Emergency Medicine (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Dermatology (AREA)
  • Toxicology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
PL16748688T 2015-02-11 2016-02-03 Stabilny preparat farmaceutyczny w postaci roztworu białka fuzyjnego przeciwciała przeciwko glp-1r PL3257524T3 (pl)

Applications Claiming Priority (3)

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
EP16748688.5A EP3257524B1 (en) 2015-02-11 2016-02-03 Stabilized solution preparation of pharmaceutical glp-1r antibody fusion protein

Publications (1)

Publication Number Publication Date
PL3257524T3 true PL3257524T3 (pl) 2021-03-08

Family

ID=56615305

Family Applications (1)

Application Number Title Priority Date Filing Date
PL16748688T PL3257524T3 (pl) 2015-02-11 2016-02-03 Stabilny preparat farmaceutyczny w postaci roztworu białka fuzyjnego przeciwciała przeciwko glp-1r

Country Status (11)

Country Link
US (1) US10485870B2 (pl)
EP (1) EP3257524B1 (pl)
JP (1) JP6731953B2 (pl)
KR (1) KR102568272B1 (pl)
CN (2) CN105854000A (pl)
AU (1) AU2016218759B2 (pl)
DK (1) DK3257524T3 (pl)
ES (1) ES2833099T3 (pl)
PL (1) PL3257524T3 (pl)
PT (1) PT3257524T (pl)
WO (1) WO2016127887A1 (pl)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3684793A1 (en) 2017-09-22 2020-07-29 Regeneron Pharmaceuticals, Inc. Glucagon-like peptide 1 receptor agonists 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
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
ATE251465T1 (de) 1998-07-31 2003-10-15 Novo Nordisk As In-vitro stimulation von beta zellen vermehrung
MY155270A (en) 1998-09-24 2015-09-30 Lilly Co Eli Use of glp-1 or analogs in treatment of stroke
KR20030027077A (ko) * 2000-09-01 2003-04-03 쥬가이 세이야쿠 가부시키가이샤 장기 안정화 용액 제제
IL155812A0 (en) 2000-12-07 2003-12-23 Lilly Co Eli Glp-1 fusion proteins
CN101128487B (zh) 2004-12-02 2012-10-10 杜门蒂斯有限公司 靶向血清白蛋白和glp-1或pyy的双特异性结构域抗体
DK1831252T3 (da) * 2004-12-22 2009-10-05 Lilly Co Eli GLP-1 analog fusionsproteinformuleringer
US20060275288A1 (en) 2005-01-20 2006-12-07 Grihalde Nelson D GLP-1 receptor agonist and allosteric modulator monoclonal antibodies and uses thereof
DE602005017628D1 (de) 2005-09-22 2009-12-24 Biocompatibles Uk Ltd Fusionspolypeptide vom glp-1 (glucagon-like peptide-1) mit erhöhten peptidaseresistenz
US20090098130A1 (en) 2007-01-05 2009-04-16 Bradshaw Curt W Glucagon-like protein-1 receptor (glp-1r) agonist compounds
ATE499088T1 (de) * 2007-07-10 2011-03-15 Lilly Co Eli Glp-1-fc fusionsprotein-formulierung
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
SG189682A1 (en) 2008-03-31 2013-05-31 Glaxo Group Ltd Drug fusions and conjugates
ES2617281T3 (es) 2009-10-28 2017-06-16 Janssen Biotech, Inc. Anticuerpos anti-glp-1r y sus usos
EP2501367B1 (en) 2009-11-17 2015-01-21 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
AU2016218759A1 (en) 2017-09-21
KR20170113585A (ko) 2017-10-12
EP3257524B1 (en) 2020-08-26
WO2016127887A1 (zh) 2016-08-18
AU2016218759B2 (en) 2021-11-25
DK3257524T3 (da) 2020-11-23
EP3257524A4 (en) 2018-09-05
EP3257524A1 (en) 2017-12-20
ES2833099T3 (es) 2021-06-14
US20180000934A1 (en) 2018-01-04
CA2975633A1 (en) 2016-08-18
CN105854000A (zh) 2016-08-17
JP6731953B2 (ja) 2020-07-29
PT3257524T (pt) 2020-11-27
CN121927035A (zh) 2026-04-28
KR102568272B1 (ko) 2023-08-21
JP2018508571A (ja) 2018-03-29
US10485870B2 (en) 2019-11-26

Similar Documents

Publication Publication Date Title
IL262652A (en) Gdf15 fusion proteins and uses thereof
PL3449940T3 (pl) Preparat zawierający przeciwciała
DK3292141T3 (da) Fusionsproteiner
EP3188758C0 (en) SIRP ALPHA-ANTIBODY FUSION PROTEIN
IL250622B (en) Prepared sirp-alpha fusion proteins and pharmaceutical preparations containing them
HUE054201T2 (hu) PD-1-CD28 fúziós fehérjék és gyógyászatban való alkalmazásuk
DK3479819T3 (da) Stabilt væskeformigt farmaceutisk præparat
IL257170A (en) Stable proteins and methods for designing same
DK3368554T3 (da) Langtidsvirkende fgf21-fusionsproteiner og farmaceutisk sammensætning omfattende samme
MA50908A (fr) Formulations de protéines de fusion vegfr-fc
IL246837B (en) Antibodies, pharmaceutical compositions and uses thereof
DK3107562T3 (da) P97-ids-fusionsproteiner
EP3561058A4 (en) Fusion protein including bdnf
CL2016000219A1 (es) Proteinas de fusión terapéutica.
HRP20190434T1 (hr) Fuzijski protein
DK3275895T3 (da) Neuropilin-1-specifikt bindingspeptid, fusionsprotein fusioneret dermed, og anvendelse deraf
EP3344278A4 (en) INSULIN-IMMUNOGLOBULIN FUSION PROTEINS
DK3199179T3 (da) Formulering af rekombinant fusionsprotein
EP3374380A4 (en) C-terminal epitopes in amyloid-beta and conformation-sensitive antibodies
IL257302B (en) Apoa-1 fusion polypeptides and related compositions and methods
EP3374379A4 (en) N-TERMINAL EPITOPES IN AMYLOID BETA AND CONFORMATION-SELECTIVE ANTIBODIES
PL3350334T3 (pl) Ekspresja rekombinowanych białek w poczwarkach trichoplusia ni
IL262967A (en) Glycosylated vwf fusion proteins with improved pharmacokinetics
BR112016019868A2 (pt) proteínas de fusão tatk-cdkl5, composições, formulações, e seu uso
EP3419651C0 (en) IMPROVED NAGLU FUSION PROTEIN FORMULATION