JP5946448B2 - 持続型ヒト成長ホルモン結合体液状製剤 - Google Patents

持続型ヒト成長ホルモン結合体液状製剤 Download PDF

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Publication number
JP5946448B2
JP5946448B2 JP2013519600A JP2013519600A JP5946448B2 JP 5946448 B2 JP5946448 B2 JP 5946448B2 JP 2013519600 A JP2013519600 A JP 2013519600A JP 2013519600 A JP2013519600 A JP 2013519600A JP 5946448 B2 JP5946448 B2 JP 5946448B2
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Prior art keywords
growth hormone
human growth
sustained
liquid preparation
region
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Expired - Fee Related
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JP2013519600A
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Japanese (ja)
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JP2013531034A5 (enExample
JP2013531034A (ja
Inventor
ヒー ホン,スン
ヒー ホン,スン
スン リー,ビュン
スン リー,ビュン
ソン イム,デ
ソン イム,デ
ミン リー,ジェ
ミン リー,ジェ
ミン バエ,スン
ミン バエ,スン
チャン クウォン,セ
チャン クウォン,セ
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Hanmi Science Co Ltd
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Hanmi Science Co Ltd
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    • 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
    • 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
    • A61K38/27Growth hormone [GH], i.e. somatotropin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61K47/06Organic 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
    • 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
    • A61K47/56Medicinal 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
    • A61K47/59Medicinal 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
    • A61K47/60Medicinal 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/06Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/30Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

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  • 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)
JP2013519600A 2010-07-14 2011-07-14 持続型ヒト成長ホルモン結合体液状製剤 Expired - Fee Related JP5946448B2 (ja)

Applications Claiming Priority (3)

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

Publications (3)

Publication Number Publication Date
JP2013531034A JP2013531034A (ja) 2013-08-01
JP2013531034A5 JP2013531034A5 (enExample) 2015-10-15
JP5946448B2 true JP5946448B2 (ja) 2016-07-06

Family

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JP2013519600A Expired - Fee Related JP5946448B2 (ja) 2010-07-14 2011-07-14 持続型ヒト成長ホルモン結合体液状製剤

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)

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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
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
AR091902A1 (es) * 2012-07-25 2015-03-11 Hanmi Pharm Ind Co Ltd Formulacion liquida de un conjugado de insulina de accion prolongada
NZ739063A (en) * 2012-11-06 2019-11-29 Hanmi Pharm Ind 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
WO2014139994A1 (en) 2013-03-11 2014-09-18 Novo Nordisk Health Care Ag Growth hormone compounds
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MY192248A (en) * 2014-03-31 2022-08-10 Hanmi Pharm Ind Co Ltd Method for improving solubility of protein and peptide by using immunoglobulin fc fragment linkage
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WO2016092550A2 (en) * 2014-12-10 2016-06-16 Opko Biologics Ltd. Methods of producing long acting ctp-modified polypeptides
KR102418477B1 (ko) 2014-12-30 2022-07-08 한미약품 주식회사 글루카곤 유도체
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EP3347031B8 (en) 2015-09-11 2021-04-28 Nutrition & Biosciences USA 1, LLC A composition comprising a protein and a polyalkoxy fatty compound
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
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Also Published As

Publication number Publication date
US9061072B2 (en) 2015-06-23
EP2593084B1 (en) 2018-03-14
RU2623026C2 (ru) 2017-06-21
AR082223A1 (es) 2012-11-21
AU2011277203B2 (en) 2015-11-12
KR20120007182A (ko) 2012-01-20
AR113034A2 (es) 2020-01-22
CA2805228A1 (en) 2012-01-19
EP2593084A4 (en) 2014-11-05
BR112013000902A2 (pt) 2020-08-25
JP2013531034A (ja) 2013-08-01
IL224225B (en) 2018-07-31
WO2012008779A2 (en) 2012-01-19
CN103068366A (zh) 2013-04-24
CA2805228C (en) 2019-05-07
EP2593084A2 (en) 2013-05-22
TW201215404A (en) 2012-04-16
WO2012008779A3 (en) 2012-05-24
US20130115231A1 (en) 2013-05-09
TWI459961B (zh) 2014-11-11
AU2011277203A1 (en) 2013-02-28
KR101337797B1 (ko) 2013-12-06
ES2673022T3 (es) 2018-06-19
RU2013106276A (ru) 2014-08-20

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