CA2805228C - A liquid formulation of long-acting human growth hormone conjugate - Google Patents

A liquid formulation of long-acting human growth hormone conjugate Download PDF

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Publication number
CA2805228C
CA2805228C CA2805228A CA2805228A CA2805228C CA 2805228 C CA2805228 C CA 2805228C CA 2805228 A CA2805228 A CA 2805228A CA 2805228 A CA2805228 A CA 2805228A CA 2805228 C CA2805228 C CA 2805228C
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CA
Canada
Prior art keywords
long
growth hormone
human growth
liquid formulation
acting
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Fee Related
Application number
CA2805228A
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English (en)
French (fr)
Other versions
CA2805228A1 (en
Inventor
Sung Hee Hong
Byung Sun Lee
Dae Seong Im
Jae Min Lee
Sung Min Bae
Se Chang Kwon
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Hanmi Science Co Ltd
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Publication of CA2805228A1 publication Critical patent/CA2805228A1/en
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Publication of CA2805228C publication Critical patent/CA2805228C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • 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
    • A61K38/27—Growth hormone [GH], i.e. somatotropin
    • 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
    • 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
    • A61K47/26—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
    • 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
    • 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
    • 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
    • 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)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (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)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CA2805228A 2010-07-14 2011-07-14 A liquid formulation of long-acting human growth hormone conjugate Expired - Fee Related CA2805228C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR10-2010-0067796 2010-07-14
KR1020100067796A KR101337797B1 (ko) 2010-07-14 2010-07-14 지속형 인간 성장 호르몬 결합체 액상 제제
PCT/KR2011/005194 WO2012008779A2 (en) 2010-07-14 2011-07-14 A liquid formulation of long-acting human growth hormone conjugate

Publications (2)

Publication Number Publication Date
CA2805228A1 CA2805228A1 (en) 2012-01-19
CA2805228C true CA2805228C (en) 2019-05-07

Family

ID=45469941

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2805228A Expired - Fee Related CA2805228C (en) 2010-07-14 2011-07-14 A liquid formulation of long-acting human growth hormone conjugate

Country Status (13)

Country Link
US (1) US9061072B2 (enExample)
EP (1) EP2593084B1 (enExample)
JP (1) JP5946448B2 (enExample)
KR (1) KR101337797B1 (enExample)
AR (2) AR082223A1 (enExample)
AU (1) AU2011277203B2 (enExample)
BR (1) BR112013000902A2 (enExample)
CA (1) CA2805228C (enExample)
ES (1) ES2673022T3 (enExample)
IL (1) IL224225B (enExample)
RU (1) RU2623026C2 (enExample)
TW (1) TWI459961B (enExample)
WO (1) WO2012008779A2 (enExample)

Families Citing this family (32)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI601744B (zh) 2011-06-17 2017-10-11 韓美科學股份有限公司 包含調酸素與免疫球蛋白片段之複合物及其用途
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
EA039082B1 (ru) 2012-11-06 2021-12-01 Ханми Фарм. Ко., Лтд. Жидкая композиция белкового конъюгата, содержащего оксинтомодулин и фрагмент иммуноглобулина
JP2016511275A (ja) 2013-03-11 2016-04-14 ノヴォ・ノルディスク・ヘルス・ケア・アーゲー 成長ホルモン化合物
SG11201505926VA (en) 2013-03-15 2015-09-29 Biogen Ma Inc Factor ix polypeptide formulations
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
CN105848645A (zh) 2013-09-27 2016-08-10 韩美药品株式会社 持续型人生长激素制剂
KR102385120B1 (ko) * 2014-03-31 2022-04-12 한미약품 주식회사 면역글로불린 Fc 단편 결합을 이용한 단백질 및 펩타이드의 용해도를 개선시키는 방법
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
KR102527180B1 (ko) 2014-12-10 2023-04-27 옵코 바이오로직스 리미티드 장기간 작용성 ctp-변형된 성장 호르몬 폴리펩타이드의 제조 방법
KR102418477B1 (ko) 2014-12-30 2022-07-08 한미약품 주식회사 글루카곤 유도체
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
US9925233B2 (en) 2015-01-30 2018-03-27 Par Pharmaceutical, Inc. Vasopressin formulations for use in treatment of hypotension
US9744209B2 (en) 2015-01-30 2017-08-29 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
EP3303380B1 (en) 2015-06-02 2020-01-15 Novo Nordisk A/S Insulins with polar recombinant extensions
DK3347403T3 (da) 2015-09-11 2020-06-29 Dow Global Technologies Llc Polyalkoxyfedtforbindelse
DK3347031T3 (da) 2015-09-11 2021-04-26 Nutrition & Biosciences Usa 1 Llc Sammensætning, der omfatter et protein og en polyalkoxyfedtforbindelse
JP2018535929A (ja) * 2015-09-24 2018-12-06 バイオマリン ファーマシューティカル インコーポレイテッド アデノ随伴ウイルス第viii因子ベクター、関連ウイルス粒子、及びそれらを含む治療的製剤
WO2017055582A1 (en) 2015-10-01 2017-04-06 Novo Nordisk A/S Protein conjugates
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
MX2024006318A (es) * 2021-11-26 2024-08-14 Genexine Inc Formulacion para administracion de alta concentracion de proteina de fusion de hormona del crecimiento.
EP4640210A1 (en) * 2022-12-23 2025-10-29 Hanmi Pharm. Co., Ltd. Formulation containing immunoactive interleukin 2 analog conjugate

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5981485A (en) * 1997-07-14 1999-11-09 Genentech, Inc. Human growth hormone aqueous formulation
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
DK0955062T3 (da) * 1992-07-31 2007-09-17 Genentech Inc Vandig formulering indeholdende humant væksthormon
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
ATE407697T1 (de) * 1999-07-13 2008-09-15 Bolder Biotechnology Inc Erythropoietin immunglobulin fusionsproteine
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
US20050176108A1 (en) 2003-03-13 2005-08-11 Young-Min Kim Physiologically active polypeptide conjugate having prolonged in vivo half-life
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
BRPI0406605B8 (pt) 2003-11-13 2021-05-25 Hanmi Holdings Co Ltd conjugado de proteína, método para a preparação do mesmo e composição farmacêutica para intensificar a duração e estabilidade in vivo de um polipeptídeo fisiologicamente ativo
JP4845741B2 (ja) 2003-12-23 2011-12-28 ファルマシア コーポレーション 安定な成長ホルモン液体製剤
WO2006048689A2 (en) * 2004-11-08 2006-05-11 Encesys Limited Integrated circuits and power supplies
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
EP2300501B1 (en) * 2008-07-23 2014-08-20 Hanmi Science Co., Ltd. A polypeptide complex comprising non-peptidyl polymer having three functional ends
MX2011005672A (es) 2008-11-28 2011-06-20 Abbott Lab Composiciones de anticuerpo estables y metodos para estabilizar a las mismas.

Also Published As

Publication number Publication date
KR101337797B1 (ko) 2013-12-06
RU2013106276A (ru) 2014-08-20
CN103068366A (zh) 2013-04-24
ES2673022T3 (es) 2018-06-19
EP2593084B1 (en) 2018-03-14
AU2011277203A1 (en) 2013-02-28
AR113034A2 (es) 2020-01-22
RU2623026C2 (ru) 2017-06-21
US20130115231A1 (en) 2013-05-09
WO2012008779A3 (en) 2012-05-24
WO2012008779A2 (en) 2012-01-19
US9061072B2 (en) 2015-06-23
EP2593084A2 (en) 2013-05-22
JP5946448B2 (ja) 2016-07-06
TWI459961B (zh) 2014-11-11
BR112013000902A2 (pt) 2020-08-25
TW201215404A (en) 2012-04-16
JP2013531034A (ja) 2013-08-01
AU2011277203B2 (en) 2015-11-12
IL224225B (en) 2018-07-31
CA2805228A1 (en) 2012-01-19
AR082223A1 (es) 2012-11-21
EP2593084A4 (en) 2014-11-05
KR20120007182A (ko) 2012-01-20

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