HUE042246T2 - Folyékony nyújtott hatású inzulin konjugátum készítmény - Google Patents

Folyékony nyújtott hatású inzulin konjugátum készítmény

Info

Publication number
HUE042246T2
HUE042246T2 HUE13822348A HUE13822348A HUE042246T2 HU E042246 T2 HUE042246 T2 HU E042246T2 HU E13822348 A HUE13822348 A HU E13822348A HU E13822348 A HUE13822348 A HU E13822348A HU E042246 T2 HUE042246 T2 HU E042246T2
Authority
HU
Hungary
Prior art keywords
long
liquid formulation
acting insulin
insulin conjugate
conjugate
Prior art date
Application number
HUE13822348A
Other languages
English (en)
Inventor
Hyung Kyu Lim
Hyun Uk Kim
Sung Hee Hong
Min Young Kim
Sung Min Bae
Se Chang Kwon
Original Assignee
Hanmi Pharm Ind Co Ltd
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 Hanmi Pharm Ind Co Ltd filed Critical Hanmi Pharm Ind Co Ltd
Publication of HUE042246T2 publication Critical patent/HUE042246T2/hu

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
    • 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
    • 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
    • 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
    • A61K38/28Insulins
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/50Medicinal 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
    • 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
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/68Medicinal 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 antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
HUE13822348A 2012-07-25 2013-07-25 Folyékony nyújtott hatású inzulin konjugátum készítmény HUE042246T2 (hu)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
KR20120081477 2012-07-25

Publications (1)

Publication Number Publication Date
HUE042246T2 true HUE042246T2 (hu) 2019-06-28

Family

ID=49997581

Family Applications (1)

Application Number Title Priority Date Filing Date
HUE13822348A HUE042246T2 (hu) 2012-07-25 2013-07-25 Folyékony nyújtott hatású inzulin konjugátum készítmény

Country Status (21)

Country Link
US (1) US10987424B2 (hu)
EP (1) EP2877157B1 (hu)
JP (2) JP6385925B2 (hu)
KR (1) KR102088856B1 (hu)
CN (1) CN104519871B (hu)
AR (1) AR091902A1 (hu)
AU (1) AU2013293718B2 (hu)
BR (1) BR112015001457B1 (hu)
CA (1) CA2879976C (hu)
CY (1) CY1121356T1 (hu)
DK (1) DK2877157T3 (hu)
ES (1) ES2715326T3 (hu)
HK (1) HK1207816A1 (hu)
HU (1) HUE042246T2 (hu)
MX (1) MX369201B (hu)
PL (1) PL2877157T3 (hu)
PT (1) PT2877157T (hu)
RU (1) RU2670270C2 (hu)
TR (1) TR201903661T4 (hu)
TW (2) TWI605824B (hu)
WO (1) WO2014017847A1 (hu)

Families Citing this family (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9180261B2 (en) 2010-01-12 2015-11-10 Dance Biopharm Inc. Preservative free insulin formulations and systems and methods for aerosolizing
US10842951B2 (en) 2010-01-12 2020-11-24 Aerami Therapeutics, Inc. Liquid insulin formulations and methods relating thereto
KR20130049671A (ko) 2011-11-04 2013-05-14 한미사이언스 주식회사 생리활성 폴리펩타이드 결합체 제조 방법
AR090281A1 (es) 2012-03-08 2014-10-29 Hanmi Science Co Ltd Proceso mejorado para la preparacion de un complejo polipeptidico fisiologicamente activo
AR091902A1 (es) * 2012-07-25 2015-03-11 Hanmi Pharm Ind Co Ltd Formulacion liquida de un conjugado de insulina de accion prolongada
CN116987172A (zh) 2014-01-20 2023-11-03 韩美药品株式会社 长效胰岛素及其用途
CA2944138C (en) * 2014-03-31 2023-06-20 Hanmi Pharm. Co., Ltd. Method for improving solubility of protein and peptide by using immunoglobulin fc fragment linkage
AR100639A1 (es) * 2014-05-29 2016-10-19 Hanmi Pharm Ind Co Ltd Composición para tratar diabetes que comprende conjugados de análogos de insulina de acción prolongada y conjugados de péptidos insulinotrópicos de acción prolongada
TWI684458B (zh) * 2014-05-30 2020-02-11 南韓商韓美藥品股份有限公司 包含胰島素及glp-1/昇糖素雙重促效劑之治療糖尿病之組成物
US10894089B2 (en) 2015-02-17 2021-01-19 Hanmi Pharm. Co., Ltd. Long-acting insulin or insulin analogue conjugate
WO2016137569A1 (en) 2015-02-25 2016-09-01 Dance Biopharm, Inc. Liquid insulin formulations and methods relating thereto
AR105616A1 (es) 2015-05-07 2017-10-25 Lilly Co Eli Proteínas de fusión
UY36870A (es) 2015-08-28 2017-03-31 Hanmi Pharm Ind Co Ltd Análogos de insulina novedosos
CN108136276B (zh) * 2015-09-24 2023-02-28 韩美药品株式会社 通过使用免疫球蛋白片段的特异性位点进行连接的蛋白质复合物
CN105597087B (zh) * 2016-01-06 2019-04-26 山东新时代药业有限公司 一种甘精胰岛素注射液及其制备方法
GB201607918D0 (en) 2016-05-06 2016-06-22 Arecor Ltd Novel formulations
TWI774694B (zh) 2016-09-23 2022-08-21 南韓商韓美藥品股份有限公司 具有降低對胰島素受體之親和力之胰島素類似物及其用途
CA3054899A1 (en) * 2017-03-23 2018-09-27 Hanmi Pharm. Co., Ltd. Insulin analog complex with reduced affinity for insulin receptor and use thereof
CN111406073A (zh) * 2017-09-29 2020-07-10 韩美药品株式会社 具有提高功效的持久性蛋白质缀合物
JP2022542301A (ja) * 2019-07-31 2022-09-30 イーライ リリー アンド カンパニー リラキシン類似体およびその使用方法
AR127619A1 (es) 2021-11-15 2024-02-14 Lilly Co Eli FORMULACIONES CONSERVADAS DE FUSIONES DE INSULINA-Fc

Family Cites Families (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2650598B1 (fr) 1989-08-03 1994-06-03 Rhone Poulenc Sante Derives de l'albumine a fonction therapeutique
FR2686901A1 (fr) 1992-01-31 1993-08-06 Rhone Poulenc Rorer Sa Nouveaux polypeptides antithrombotiques, leur preparation et compositions pharmaceutiques les contenant.
FR2686899B1 (fr) 1992-01-31 1995-09-01 Rhone Poulenc Rorer Sa Nouveaux polypeptides biologiquement actifs, leur preparation et compositions pharmaceutiques les contenant.
US6096871A (en) 1995-04-14 2000-08-01 Genentech, Inc. Polypeptides altered to contain an epitope from the Fc region of an IgG molecule for increased half-life
CA2249195A1 (en) 1996-03-18 1997-09-25 Board Of Regents, The University Of Texas System Immunoglobin-like domains with increased half lives
US5783556A (en) * 1996-08-13 1998-07-21 Genentech, Inc. Formulated insulin-containing composition
US20020019352A1 (en) 1997-04-17 2002-02-14 David N. Brems Stable, active, human ob protein compositions and methods
US6924264B1 (en) 1999-04-30 2005-08-02 Amylin Pharmaceuticals, Inc. Modified exendins and exendin agonists
SK782002A3 (en) * 1999-07-21 2003-08-05 Lexigen Pharm Corp FC fusion proteins for enhancing the immunogenicity of protein and peptide antigens
US6756480B2 (en) 2000-04-27 2004-06-29 Amgen Inc. Modulators of receptors for parathyroid hormone and parathyroid hormone-related protein
EP1355942B1 (en) * 2000-12-07 2008-08-27 Eli Lilly And Company Glp-1 fusion proteins
US20060183197A1 (en) 2001-01-11 2006-08-17 Andersen Kim V Variant growth hormone molecules conjugated with macromolecules compounds
US6737401B2 (en) * 2001-06-28 2004-05-18 Metronic Minimed, Inc. Methods of evaluating protein formulation stability and surfactant-stabilized insulin formulations derived therefrom
PT3417875T (pt) * 2003-02-10 2020-08-24 Biogen Ma Inc Formulação de imunoglobulinas e método de preparação das mesmas
US20050176108A1 (en) 2003-03-13 2005-08-11 Young-Min Kim Physiologically active polypeptide conjugate having prolonged in vivo half-life
DE10333317A1 (de) * 2003-07-22 2005-02-17 Biotecon Therapeutics Gmbh Formulierung für Proteinarzneimittel ohne Zusatz von humanem Serumalbumin (HSA)
KR101135244B1 (ko) * 2007-11-29 2012-04-24 한미사이언스 주식회사 인슐린 분비 펩타이드 결합체를 포함하는 비만 관련질환 치료용 조성물
US8263084B2 (en) * 2003-11-13 2012-09-11 Hanmi Science Co., Ltd Pharmaceutical composition for treating obesity-related disease comprising insulinotropic peptide conjugate
PT2256134E (pt) 2003-11-13 2014-03-05 Hanmi Science Co Ltd Fragmento fc de igg para um veículo de fármaco e método para a preparação do mesmo
US20080207505A1 (en) 2005-01-12 2008-08-28 James Kenneth D Bna Conjugates and Methods of Use
KR20090113340A (ko) * 2007-03-22 2009-10-29 임클론 엘엘씨 안정한 항체 제제
EA201070121A1 (ru) 2007-07-10 2010-06-30 Эли Лилли Энд Компани Лекарственная форма, содержащая слитый белок glp-1-fc
WO2011041003A2 (en) * 2009-06-22 2011-04-07 Wyeth Llc Compositions and methods for preparing staphylococcus aureus serotype 5 and 8 capsular polysaccharide conjugate immunogenic compositions
WO2011090306A2 (en) * 2010-01-19 2011-07-28 Hanmi Holdings Co., Ltd Liquid formulations for long-acting erythropoietin conjugate
AR081066A1 (es) * 2010-04-02 2012-06-06 Hanmi Holdings Co Ltd Conjugado de insulina donde se usa un fragmento de inmunoglobulina
KR101324828B1 (ko) 2010-06-08 2013-11-01 한미사이언스 주식회사 면역글로불린 단편을 이용한 단쇄 인슐린 아날로그 약물 결합체
KR101330868B1 (ko) 2010-06-08 2013-11-18 한미사이언스 주식회사 면역글로불린 단편을 이용한 인슐린 유도체 약물 결합체
KR101337797B1 (ko) 2010-07-14 2013-12-06 한미사이언스 주식회사 지속형 인간 성장 호르몬 결합체 액상 제제
KR101303388B1 (ko) * 2010-10-26 2013-09-03 한미사이언스 주식회사 지속형 인터페론 알파 결합체의 액상 제제
AR091902A1 (es) 2012-07-25 2015-03-11 Hanmi Pharm Ind Co Ltd Formulacion liquida de un conjugado de insulina de accion prolongada

Also Published As

Publication number Publication date
JP2018119005A (ja) 2018-08-02
AU2013293718A1 (en) 2015-02-12
US10987424B2 (en) 2021-04-27
CY1121356T1 (el) 2020-05-29
PL2877157T3 (pl) 2019-06-28
EP2877157A1 (en) 2015-06-03
PT2877157T (pt) 2019-03-22
AU2013293718B2 (en) 2018-05-10
AR091902A1 (es) 2015-03-11
EP2877157A4 (en) 2016-06-01
MX369201B (es) 2019-10-30
TWI605824B (zh) 2017-11-21
KR20140015207A (ko) 2014-02-06
RU2670270C2 (ru) 2018-10-22
CN104519871A (zh) 2015-04-15
EP2877157B1 (en) 2018-12-12
TW201803587A (zh) 2018-02-01
CA2879976A1 (en) 2014-01-30
BR112015001457A8 (pt) 2018-01-23
KR102088856B1 (ko) 2020-03-13
MX2015000988A (es) 2015-11-13
RU2015104495A (ru) 2016-09-10
TW201412328A (zh) 2014-04-01
CN104519871B (zh) 2018-07-20
WO2014017847A1 (en) 2014-01-30
JP2015524428A (ja) 2015-08-24
BR112015001457A2 (pt) 2017-07-04
BR112015001457B1 (pt) 2023-02-28
JP6682570B2 (ja) 2020-04-15
DK2877157T3 (en) 2019-03-25
ES2715326T3 (es) 2019-06-03
TR201903661T4 (tr) 2019-04-22
JP6385925B2 (ja) 2018-09-05
US20150196643A1 (en) 2015-07-16
CA2879976C (en) 2023-03-07
HK1207816A1 (en) 2016-02-12

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