TWI459961B - 長效人類生長激素共軛物之液態配方 - Google Patents
長效人類生長激素共軛物之液態配方 Download PDFInfo
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- TWI459961B TWI459961B TW100125060A TW100125060A TWI459961B TW I459961 B TWI459961 B TW I459961B TW 100125060 A TW100125060 A TW 100125060A TW 100125060 A TW100125060 A TW 100125060A TW I459961 B TWI459961 B TW I459961B
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- growth hormone
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Classifications
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- 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
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- 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
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- 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
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- 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
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- A—HUMAN NECESSITIES
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- 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
- A61K47/56—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
- A61K47/59—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
- A61K47/60—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/08—Solutions
-
- 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
- A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
- C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Endocrinology (AREA)
- Immunology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Organic Chemistry (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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| TW (1) | TWI459961B (enExample) |
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Families Citing this family (33)
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| RU2733544C2 (ru) | 2011-06-17 | 2020-10-05 | Ханми Сайенс Ко., Лтд. | Конъюгат, содержащий оксинтомодулин и фрагмент иммуноглобулина, и его применение |
| 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 |
| US10064951B2 (en) * | 2012-03-30 | 2018-09-04 | Hanmi Science Co., Ltd. | Liquid formulation of highly concentrated long-acting human growth hormone conjugate |
| AR091902A1 (es) | 2012-07-25 | 2015-03-11 | Hanmi Pharm Ind Co Ltd | Formulacion liquida de un conjugado de insulina de accion prolongada |
| AR092862A1 (es) * | 2012-07-25 | 2015-05-06 | Hanmi Pharm Ind Co Ltd | Formulacion liquida de insulina de accion prolongada y un peptido insulinotropico y metodo de preparacion |
| EP3610856B1 (en) * | 2012-11-06 | 2021-08-18 | Hanmi Pharm. Co., Ltd. | Liquid formulation of protein conjugate comprising the oxyntomodulin and an immunoglobulin fragment |
| CN105229035A (zh) * | 2013-03-11 | 2016-01-06 | 诺和诺德保健股份有限公司 | 生长激素化合物 |
| TW201513880A (zh) | 2013-03-11 | 2015-04-16 | Novo Nordisk As | 生長激素化合物 |
| TWI788044B (zh) | 2013-03-15 | 2022-12-21 | 美商百歐維拉提夫治療公司 | 因子ｉｘ多肽調配物 |
| AR096890A1 (es) * | 2013-07-12 | 2016-02-03 | Hanmi Pharm Ind Co Ltd | Conjugando fc de inmunoglobulina, que mantiene la afinidad de unión del fragmento fc de la inmunoglobulina a fcrn |
| EP3689335A1 (en) * | 2013-09-27 | 2020-08-05 | Hanmi Pharm. Co., Ltd. | Sustained type human growth hormone preparation |
| SG11201608120TA (en) * | 2014-03-31 | 2016-11-29 | Hanmi Pharm Ind Co Ltd | Method for improving solubility of protein and peptide by using immunoglobulin fc fragment linkage |
| TWI772252B (zh) | 2014-09-16 | 2022-08-01 | 南韓商韓美藥品股份有限公司 | 長效glp-1/高血糖素受體雙促效劑治療非酒精性脂肝疾病之用途 |
| KR20200118505A (ko) | 2014-12-10 | 2020-10-15 | 옵코 바이오로직스 리미티드 | 장기간 작용성 ctp-변형된 성장 호르몬 폴리펩타이드의 제조 방법 |
| KR102418477B1 (ko) | 2014-12-30 | 2022-07-08 | 한미약품 주식회사 | 글루카곤 유도체 |
| US9744209B2 (en) | 2015-01-30 | 2017-08-29 | Par Pharmaceutical, Inc. | Vasopressin formulations for use in treatment of hypotension |
| US9925233B2 (en) | 2015-01-30 | 2018-03-27 | Par Pharmaceutical, Inc. | Vasopressin formulations for use in treatment of hypotension |
| US9375478B1 (en) * | 2015-01-30 | 2016-06-28 | Par Pharmaceutical, Inc. | Vasopressin formulations for use in treatment of hypotension |
| US9750785B2 (en) | 2015-01-30 | 2017-09-05 | Par Pharmaceutical, Inc. | Vasopressin formulations for use in treatment of hypotension |
| US9687526B2 (en) | 2015-01-30 | 2017-06-27 | Par Pharmaceutical, Inc. | Vasopressin formulations for use in treatment of hypotension |
| US9937223B2 (en) | 2015-01-30 | 2018-04-10 | Par Pharmaceutical, Inc. | Vasopressin formulations for use in treatment of hypotension |
| WO2016193380A1 (en) | 2015-06-02 | 2016-12-08 | Novo Nordisk A/S | Insulins with polar recombinant extensions |
| JP6846409B2 (ja) | 2015-09-11 | 2021-03-24 | ダウ グローバル テクノロジーズ エルエルシー | ポリアルコキシ脂肪族化合物 |
| DK3347031T3 (da) * | 2015-09-11 | 2021-04-26 | Nutrition & Biosciences Usa 1 Llc | Sammensætning, der omfatter et protein og en polyalkoxyfedtforbindelse |
| TWI756185B (zh) * | 2015-09-24 | 2022-03-01 | 美商拜奧馬林製藥公司 | 腺相關病毒因子viii載體、相關病毒粒子及包含其之治療調配物 |
| MA43348A (fr) | 2015-10-01 | 2018-08-08 | Novo Nordisk As | Conjugués de protéines |
| KR20170079409A (ko) * | 2015-12-30 | 2017-07-10 | 한미약품 주식회사 | 지속형 인간 성장 호르몬 결합체의 신규 액상 제제 |
| JP2020513019A (ja) | 2017-04-05 | 2020-04-30 | ノヴォ ノルディスク アー／エス | オリゴマー伸長インスリン−Ｆｃコンジュゲート |
| JP7604174B2 (ja) * | 2019-10-30 | 2024-12-23 | Ｊｃｒファーマ株式会社 | 血清アルブミンと成長ホルモンの融合蛋白質を含有する水性医薬組成物 |
| US12196531B2 (en) | 2020-07-17 | 2025-01-14 | ProtectEd Solutions LLC | Protective cabinet |
| CA3238895A1 (en) * | 2021-11-26 | 2023-06-01 | Genexine, Inc. | High-concentration administration formulation of hgh fusion protein |
| WO2024136575A1 (ko) * | 2022-12-23 | 2024-06-27 | 한미약품 주식회사 | 면역 활성 인터루킨 2 아날로그 결합체를 포함하는 제제 |
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| US20010007858A1 (en) * | 1988-04-15 | 2001-07-12 | Genentech, Inc. | Human growth hormone aqueous formulation |
| CN1761684A (zh) * | 2003-03-13 | 2006-04-19 | 韩美药品株式会社 | 具有延长的体内半衰期的生理学活性多肽缀合物 |
| US20100172862A1 (en) * | 2008-11-28 | 2010-07-08 | Abbott Laboratories | Stable antibody compositions and methods of stabilizing same |
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| US5096885A (en) * | 1988-04-15 | 1992-03-17 | Genentech, Inc. | Human growth hormone formulation |
| SE9201073D0 (sv) * | 1992-04-03 | 1992-04-03 | Kabi Pharmacia Ab | Protein formulation |
| ES2153385T5 (es) | 1992-07-31 | 2008-09-01 | Genentech, Inc. | Composicion acuosa a base de hormona del crecimiento humana. |
| US5519253A (en) * | 1993-09-07 | 1996-05-21 | Delco Electronics Corp. | Coaxial switch module |
| US20020077461A1 (en) * | 1996-04-24 | 2002-06-20 | Soren Bjorn | Pharmaceutical formulation |
| JP3723857B2 (ja) * | 1998-02-04 | 2005-12-07 | 日本ケミカルリサーチ株式会社 | ヒト成長ホルモン含有水性医薬組成物 |
| JP4944324B2 (ja) * | 1999-07-13 | 2012-05-30 | ボルダー バイオテクノロジー， インコーポレイテッド | 免疫グロブリン融合タンパク質 |
| GB2371227A (en) * | 2001-01-10 | 2002-07-24 | Grandis Biotech Gmbh | Crystallisation - resistant aqueous growth hormone formulations |
| US20060183197A1 (en) * | 2001-01-11 | 2006-08-17 | Andersen Kim V | Variant growth hormone molecules conjugated with macromolecules compounds |
| US20040180054A1 (en) | 2003-03-13 | 2004-09-16 | Hanmi Pharm. Co., Ltd. | Physiologically active polypeptide conjugate having prolonged in vivo half-life |
| KR100537260B1 (ko) * | 2003-09-03 | 2005-12-19 | 한미약품 주식회사 | 인간 성장 호르몬의 안정화된 액상 제제용 조성물 |
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| CA2551510C (en) * | 2003-12-23 | 2013-07-30 | Pharmacia Corporation | Stable growth hormone liquid formulation |
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| KR100754667B1 (ko) * | 2005-04-08 | 2007-09-03 | 한미약품 주식회사 | 비펩타이드성 중합체로 개질된 면역글로불린 Ｆｃ 단편 및이를 포함하는 약제학적 조성물 |
| KR100739728B1 (ko) * | 2005-09-01 | 2007-07-13 | 삼성전자주식회사 | 화상형성시스템 및 화상 형성 방법 |
| US8400775B2 (en) * | 2007-07-06 | 2013-03-19 | GM Global Technology Operations LLC | Capacitor with direct DC connection to substrate |
| RU2483081C2 (ru) * | 2008-07-23 | 2013-05-27 | Ханми Сайенс Ко.,Лтд.,Kr | Полипептидный комплекс, содержащий непептидильный полимер, обладающий тремя функциональными концами |
-
2010
- 2010-07-14 KR KR1020100067796A patent/KR101337797B1/ko not_active Expired - Fee Related
-
2011
- 2011-07-14 US US13/809,783 patent/US9061072B2/en not_active Expired - Fee Related
- 2011-07-14 AR ARP110102545A patent/AR082223A1/es not_active Application Discontinuation
- 2011-07-14 WO PCT/KR2011/005194 patent/WO2012008779A2/en not_active Ceased
- 2011-07-14 BR BR112013000902-0A patent/BR112013000902A2/pt not_active IP Right Cessation
- 2011-07-14 AU AU2011277203A patent/AU2011277203B2/en not_active Ceased
- 2011-07-14 TW TW100125060A patent/TWI459961B/zh not_active IP Right Cessation
- 2011-07-14 EP EP11807064.8A patent/EP2593084B1/en not_active Not-in-force
- 2011-07-14 RU RU2013106276A patent/RU2623026C2/ru not_active IP Right Cessation
- 2011-07-14 ES ES11807064.8T patent/ES2673022T3/es active Active
- 2011-07-14 CA CA2805228A patent/CA2805228C/en not_active Expired - Fee Related
- 2011-07-14 JP JP2013519600A patent/JP5946448B2/ja not_active Expired - Fee Related
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2013
- 2013-01-14 IL IL224225A patent/IL224225B/en active IP Right Grant
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2018
- 2018-03-20 AR ARP180100643A patent/AR113034A2/es unknown
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20010007858A1 (en) * | 1988-04-15 | 2001-07-12 | Genentech, Inc. | Human growth hormone aqueous formulation |
| CN1761684A (zh) * | 2003-03-13 | 2006-04-19 | 韩美药品株式会社 | 具有延长的体内半衰期的生理学活性多肽缀合物 |
| US20100172862A1 (en) * | 2008-11-28 | 2010-07-08 | Abbott Laboratories | Stable antibody compositions and methods of stabilizing same |
Also Published As
| Publication number | Publication date |
|---|---|
| RU2013106276A (ru) | 2014-08-20 |
| CA2805228C (en) | 2019-05-07 |
| CN103068366A (zh) | 2013-04-24 |
| RU2623026C2 (ru) | 2017-06-21 |
| KR101337797B1 (ko) | 2013-12-06 |
| JP2013531034A (ja) | 2013-08-01 |
| AR082223A1 (es) | 2012-11-21 |
| JP5946448B2 (ja) | 2016-07-06 |
| US9061072B2 (en) | 2015-06-23 |
| AU2011277203A1 (en) | 2013-02-28 |
| US20130115231A1 (en) | 2013-05-09 |
| AU2011277203B2 (en) | 2015-11-12 |
| BR112013000902A2 (pt) | 2020-08-25 |
| WO2012008779A2 (en) | 2012-01-19 |
| EP2593084A2 (en) | 2013-05-22 |
| AR113034A2 (es) | 2020-01-22 |
| WO2012008779A3 (en) | 2012-05-24 |
| ES2673022T3 (es) | 2018-06-19 |
| EP2593084A4 (en) | 2014-11-05 |
| CA2805228A1 (en) | 2012-01-19 |
| TW201215404A (en) | 2012-04-16 |
| IL224225B (en) | 2018-07-31 |
| KR20120007182A (ko) | 2012-01-20 |
| EP2593084B1 (en) | 2018-03-14 |
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| MM4A | Annulment or lapse of patent due to non-payment of fees |