DK3257524T3 - Stabiliseret opløsningspræparat af farmaceutisk glp-1r-antistoffusionsprotein - Google Patents
Stabiliseret opløsningspræparat af farmaceutisk glp-1r-antistoffusionsprotein Download PDFInfo
- Publication number
- DK3257524T3 DK3257524T3 DK16748688.5T DK16748688T DK3257524T3 DK 3257524 T3 DK3257524 T3 DK 3257524T3 DK 16748688 T DK16748688 T DK 16748688T DK 3257524 T3 DK3257524 T3 DK 3257524T3
- Authority
- DK
- Denmark
- Prior art keywords
- glp
- antibodies
- pharmaceutical
- solution preparation
- stabilized solution
- Prior art date
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 [IGs], e.g. monoclonal or polyclonal antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2869—Immunoglobulins [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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (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)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Emergency Medicine (AREA)
- Biomedical Technology (AREA)
- Dermatology (AREA)
- Toxicology (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)
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 |
|---|---|
| DK3257524T3 true DK3257524T3 (da) | 2020-11-23 |
Family
ID=56615305
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK16748688.5T DK3257524T3 (da) | 2015-02-11 | 2016-02-03 | Stabiliseret opløsningspræparat af farmaceutisk glp-1r-antistoffusionsprotein |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US10485870B2 (da) |
| EP (1) | EP3257524B1 (da) |
| JP (1) | JP6731953B2 (da) |
| KR (1) | KR102568272B1 (da) |
| CN (1) | CN105854000A (da) |
| AU (1) | AU2016218759B2 (da) |
| CA (1) | CA2975633A1 (da) |
| DK (1) | DK3257524T3 (da) |
| ES (1) | ES2833099T3 (da) |
| PL (1) | PL3257524T3 (da) |
| PT (1) | PT3257524T (da) |
| WO (1) | WO2016127887A1 (da) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP7239566B2 (ja) | 2017-09-22 | 2023-03-14 | リジェネロン・ファーマシューティカルズ・インコーポレイテッド | グルカゴン様ペプチド１受容体アゴニストおよびそれらの使用 |
| WO2024064842A1 (en) | 2022-09-21 | 2024-03-28 | Regeneron Pharmaceuticals, Inc. | Methods of treating obesity, diabetes, and liver dysfunction |
Family Cites Families (24)
| 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 |
| WO2000007617A1 (en) | 1998-07-31 | 2000-02-17 | 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 |
| NZ524482A (en) * | 2000-09-01 | 2005-11-25 | Chugai Pharmaceutical Co Ltd | Solution formulations having long-term stability |
| US7271149B2 (en) | 2000-12-07 | 2007-09-18 | Eli Lilly And Company | 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 |
| SI1831252T1 (sl) * | 2004-12-22 | 2009-12-31 | Lilly Co Eli | Formulacije analogov glp-1 fuzijskih proteinov |
| US20060275288A1 (en) | 2005-01-20 | 2006-12-07 | Grihalde Nelson D | GLP-1 receptor agonist and allosteric modulator monoclonal antibodies and uses thereof |
| DK1767545T3 (da) | 2005-09-22 | 2010-03-15 | Biocompatibles Uk Ltd | GLP-1 (Glucagon-lignende peptid-1)-fusionspolypeptider med forøget peptidaseresistens |
| US20090098130A1 (en) | 2007-01-05 | 2009-04-16 | Bradshaw Curt W | Glucagon-like protein-1 receptor (glp-1r) agonist compounds |
| WO2009009562A2 (en) * | 2007-07-10 | 2009-01-15 | Eli Lilly And Company | Glp-1-fc fusion protein formulation |
| 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 |
| US20110020345A1 (en) | 2008-03-31 | 2011-01-27 | Christopher Herring | Drug fusions and conjugates |
| WO2011056644A2 (en) | 2009-10-28 | 2011-05-12 | Centocor Ortho Biotech Inc. | Anti-glp-1r antibodies and their uses |
| 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 |
-
2016
- 2016-02-03 WO PCT/CN2016/073279 patent/WO2016127887A1/zh active Application Filing
- 2016-02-03 JP JP2017560858A patent/JP6731953B2/ja active Active
- 2016-02-03 PT PT167486885T patent/PT3257524T/pt unknown
- 2016-02-03 EP EP16748688.5A patent/EP3257524B1/en active Active
- 2016-02-03 KR KR1020177023260A patent/KR102568272B1/ko active IP Right Grant
- 2016-02-03 AU AU2016218759A patent/AU2016218759B2/en active Active
- 2016-02-03 DK DK16748688.5T patent/DK3257524T3/da active
- 2016-02-03 CA CA2975633A patent/CA2975633A1/en active Pending
- 2016-02-03 ES ES16748688T patent/ES2833099T3/es active Active
- 2016-02-03 CN CN201610077253.8A patent/CN105854000A/zh active Pending
- 2016-02-03 US US15/547,727 patent/US10485870B2/en active Active
- 2016-02-03 PL PL16748688T patent/PL3257524T3/pl unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP3257524A1 (en) | 2017-12-20 |
| CA2975633A1 (en) | 2016-08-18 |
| AU2016218759A1 (en) | 2017-09-21 |
| PL3257524T3 (pl) | 2021-03-08 |
| EP3257524B1 (en) | 2020-08-26 |
| US20180000934A1 (en) | 2018-01-04 |
| EP3257524A4 (en) | 2018-09-05 |
| JP6731953B2 (ja) | 2020-07-29 |
| AU2016218759B2 (en) | 2021-11-25 |
| KR20170113585A (ko) | 2017-10-12 |
| WO2016127887A1 (zh) | 2016-08-18 |
| PT3257524T (pt) | 2020-11-27 |
| ES2833099T3 (es) | 2021-06-14 |
| JP2018508571A (ja) | 2018-03-29 |
| CN105854000A (zh) | 2016-08-17 |
| US10485870B2 (en) | 2019-11-26 |
| KR102568272B1 (ko) | 2023-08-21 |
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