BR112015001457A8 - formulação líquida de conjugado de insulina de ação prolongada. - Google Patents
formulação líquida de conjugado de insulina de ação prolongada.Info
- Publication number
- BR112015001457A8 BR112015001457A8 BR112015001457A BR112015001457A BR112015001457A8 BR 112015001457 A8 BR112015001457 A8 BR 112015001457A8 BR 112015001457 A BR112015001457 A BR 112015001457A BR 112015001457 A BR112015001457 A BR 112015001457A BR 112015001457 A8 BR112015001457 A8 BR 112015001457A8
- Authority
- BR
- Brazil
- Prior art keywords
- long
- liquid formulation
- acting insulin
- insulin conjugate
- conjugate liquid
- Prior art date
Links
Classifications
-
- 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
- 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
- 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
- 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
- A61K38/28—Insulins
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
-
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/68—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 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
-
- 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
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR10-2012-0081477 | 2012-07-25 | ||
| KR20120081477 | 2012-07-25 | ||
| PCT/KR2013/006673 WO2014017847A1 (en) | 2012-07-25 | 2013-07-25 | A liquid formulation of long-acting insulin conjugate |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| BR112015001457A2 BR112015001457A2 (pt) | 2017-07-04 |
| BR112015001457A8 true BR112015001457A8 (pt) | 2018-01-23 |
| BR112015001457B1 BR112015001457B1 (pt) | 2023-02-28 |
Family
ID=49997581
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112015001457-7A BR112015001457B1 (pt) | 2012-07-25 | 2013-07-25 | Formulação líquida de conjugado de insulina de ação prolongada |
Country Status (21)
| Country | Link |
|---|---|
| US (1) | US10987424B2 (pt) |
| EP (1) | EP2877157B1 (pt) |
| JP (2) | JP6385925B2 (pt) |
| KR (1) | KR102088856B1 (pt) |
| CN (1) | CN104519871B (pt) |
| AR (1) | AR091902A1 (pt) |
| AU (1) | AU2013293718B2 (pt) |
| BR (1) | BR112015001457B1 (pt) |
| CA (1) | CA2879976C (pt) |
| CY (1) | CY1121356T1 (pt) |
| DK (1) | DK2877157T3 (pt) |
| ES (1) | ES2715326T3 (pt) |
| HK (1) | HK1207816A1 (pt) |
| HU (1) | HUE042246T2 (pt) |
| MX (1) | MX369201B (pt) |
| PL (1) | PL2877157T3 (pt) |
| PT (1) | PT2877157T (pt) |
| RU (1) | RU2670270C2 (pt) |
| TR (1) | TR201903661T4 (pt) |
| TW (2) | TWI605824B (pt) |
| WO (1) | WO2014017847A1 (pt) |
Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10842951B2 (en) | 2010-01-12 | 2020-11-24 | Aerami Therapeutics, Inc. | Liquid insulin formulations and methods relating thereto |
| US9180261B2 (en) | 2010-01-12 | 2015-11-10 | Dance Biopharm Inc. | Preservative free insulin formulations and systems and methods for aerosolizing |
| 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 |
| EP3098235A4 (en) | 2014-01-20 | 2017-10-18 | Hanmi Pharm. Co., Ltd. | Long-acting insulin and use thereof |
| CN117065044A (zh) * | 2014-03-31 | 2023-11-17 | 韩美药品株式会社 | 通过使用免疫球蛋白Fc片段连接改善蛋白质和肽的溶解度的方法 |
| 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 |
| KR20160101702A (ko) | 2015-02-17 | 2016-08-25 | 한미약품 주식회사 | 지속형 인슐린 또는 이의 아날로그 결합체 |
| CA3011902C (en) * | 2015-02-25 | 2023-08-15 | 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 |
| EP3341025A4 (en) * | 2015-09-24 | 2019-05-01 | Hanmi Pharm. Co., Ltd. | PROTEIN COMPLEX BY USING A SPECIFIC ROLE OF AN IMMUNOMOBILIN FRAGMENT FOR LINKING |
| 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 |
| EP3517544A4 (en) | 2016-09-23 | 2020-06-03 | Hanmi Pharm. Co., Ltd. | INSULIN ANALOG HAVING REDUCED INSULIN RECEPTOR BINDING FORCE AND USE THEREOF |
| JP2020511513A (ja) * | 2017-03-23 | 2020-04-16 | ハンミ ファーマシューティカル カンパニー リミテッド | インスリン受容体との結合力が減少されたインスリンアナログの結合体及びその用途 |
| JP2020535199A (ja) * | 2017-09-29 | 2020-12-03 | ハンミ ファーマシューティカル カンパニー リミテッド | 効力が向上した持続性タンパク質結合体 |
| TW202120536A (zh) * | 2019-07-31 | 2021-06-01 | 美商美國禮來大藥廠 | 鬆弛素(relaxin)類似物及其使用方法 |
| AR127619A1 (es) | 2021-11-15 | 2024-02-14 | Lilly Co Eli | FORMULACIONES CONSERVADAS DE FUSIONES DE INSULINA-Fc |
Family Cites Families (30)
| 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 |
| CA2434237C (en) * | 2000-12-07 | 2012-05-15 | 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 |
| KR20050047030A (ko) | 2003-11-13 | 2005-05-19 | 한미약품 주식회사 | 약물의 캐리어로서 유용한 ＩｇＧ Ｆｃ 단편 및 그의제조방법 |
| WO2006076471A2 (en) | 2005-01-12 | 2006-07-20 | Nobex Corporation | Bnp conjugates and methods of use |
| EA200970880A1 (ru) * | 2007-03-22 | 2010-02-26 | Имклоун Элэлси | Стабильные композиции на основе антител |
| EA201070121A1 (ru) | 2007-07-10 | 2010-06-30 | Эли Лилли Энд Компани | Лекарственная форма, содержащая слитый белок glp-1-fc |
| PE20110065A1 (es) | 2009-06-22 | 2011-01-31 | Wyeth Llc | Composiciones y metodos para preparar composiciones inmunogenicas de conjugado de polisacarido capsular de staphylococcus aureus serotipos 5 y 8 |
| RU2012135505A (ru) * | 2010-01-19 | 2014-02-27 | Ханми Сайенс Ко., Лтд. | Жидкие составы для конъюгата этитропоэтина длительного действия |
| AR081066A1 (es) | 2010-04-02 | 2012-06-06 | Hanmi Holdings Co Ltd | Conjugado de insulina donde se usa un fragmento de inmunoglobulina |
| KR101330868B1 (ko) | 2010-06-08 | 2013-11-18 | 한미사이언스 주식회사 | 면역글로불린 단편을 이용한 인슐린 유도체 약물 결합체 |
| KR101324828B1 (ko) | 2010-06-08 | 2013-11-01 | 한미사이언스 주식회사 | 면역글로불린 단편을 이용한 단쇄 인슐린 아날로그 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 |
-
2013
- 2013-07-24 AR ARP130102651A patent/AR091902A1/es unknown
- 2013-07-25 HU HUE13822348A patent/HUE042246T2/hu unknown
- 2013-07-25 RU RU2015104495A patent/RU2670270C2/ru active
- 2013-07-25 EP EP13822348.2A patent/EP2877157B1/en active Active
- 2013-07-25 TR TR2019/03661T patent/TR201903661T4/tr unknown
- 2013-07-25 AU AU2013293718A patent/AU2013293718B2/en active Active
- 2013-07-25 PL PL13822348T patent/PL2877157T3/pl unknown
- 2013-07-25 DK DK13822348.2T patent/DK2877157T3/en active
- 2013-07-25 US US14/415,206 patent/US10987424B2/en active Active
- 2013-07-25 PT PT13822348T patent/PT2877157T/pt unknown
- 2013-07-25 MX MX2015000988A patent/MX369201B/es active IP Right Grant
- 2013-07-25 CA CA2879976A patent/CA2879976C/en active Active
- 2013-07-25 BR BR112015001457-7A patent/BR112015001457B1/pt active IP Right Grant
- 2013-07-25 KR KR1020130087909A patent/KR102088856B1/ko active IP Right Grant
- 2013-07-25 CN CN201380039653.4A patent/CN104519871B/zh active Active
- 2013-07-25 JP JP2015524184A patent/JP6385925B2/ja active Active
- 2013-07-25 TW TW102126620A patent/TWI605824B/zh not_active IP Right Cessation
- 2013-07-25 TW TW106135078A patent/TW201803587A/zh unknown
- 2013-07-25 ES ES13822348T patent/ES2715326T3/es active Active
- 2013-07-25 WO PCT/KR2013/006673 patent/WO2014017847A1/en active Application Filing
-
2015
- 2015-07-07 HK HK15106482.5A patent/HK1207816A1/xx unknown
-
2018
- 2018-04-18 JP JP2018079838A patent/JP6682570B2/ja active Active
-
2019
- 2019-03-12 CY CY20191100288T patent/CY1121356T1/el unknown
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B07D | Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette] | ||
| B06F | Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette] | ||
| B06F | Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette] | ||
| B06I | Publication of requirement cancelled [chapter 6.9 patent gazette] |
Free format text: ANULADA A PUBLICACAO CODIGO 6.6.1 NA RPI NO 2462 DE 13/03/2018 POR TER SIDO INDEVIDA. |
|
| B15K | Others concerning applications: alteration of classification |
Ipc: A61K 9/08 (2006.01), A61K 38/26 (2006.01), A61K 38 |
|
| B07E | Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette] |
Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI |
|
| B06U | Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette] | ||
| B06A | Patent application procedure suspended [chapter 6.1 patent gazette] | ||
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