KR101337797B1 - 지속형 인간 성장 호르몬 결합체 액상 제제 - Google Patents

지속형 인간 성장 호르몬 결합체 액상 제제 Download PDF

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Publication number
KR101337797B1
KR101337797B1 KR1020100067796A KR20100067796A KR101337797B1 KR 101337797 B1 KR101337797 B1 KR 101337797B1 KR 1020100067796 A KR1020100067796 A KR 1020100067796A KR 20100067796 A KR20100067796 A KR 20100067796A KR 101337797 B1 KR101337797 B1 KR 101337797B1
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KR
South Korea
Prior art keywords
growth hormone
human growth
liquid formulation
hgh
sustained
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Expired - Fee Related
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KR1020100067796A
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English (en)
Korean (ko)
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KR20120007182A (ko
Inventor
홍성희
이병선
임대성
이재민
배성민
권세창
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한미사이언스 주식회사
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Priority to KR1020100067796A priority Critical patent/KR101337797B1/ko
Application filed by 한미사이언스 주식회사 filed Critical 한미사이언스 주식회사
Priority to EP11807064.8A priority patent/EP2593084B1/en
Priority to PCT/KR2011/005194 priority patent/WO2012008779A2/en
Priority to JP2013519600A priority patent/JP5946448B2/ja
Priority to CA2805228A priority patent/CA2805228C/en
Priority to CN201180039263.8A priority patent/CN103068366B/zh
Priority to ARP110102545A priority patent/AR082223A1/es
Priority to AU2011277203A priority patent/AU2011277203B2/en
Priority to ES11807064.8T priority patent/ES2673022T3/es
Priority to BR112013000902-0A priority patent/BR112013000902A2/pt
Priority to TW100125060A priority patent/TWI459961B/zh
Priority to US13/809,783 priority patent/US9061072B2/en
Priority to RU2013106276A priority patent/RU2623026C2/ru
Publication of KR20120007182A publication Critical patent/KR20120007182A/ko
Priority to IL224225A priority patent/IL224225B/en
Application granted granted Critical
Publication of KR101337797B1 publication Critical patent/KR101337797B1/ko
Priority to ARP180100643A priority patent/AR113034A2/es
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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    • 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
    • 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
    • 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

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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)
  • 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)
KR1020100067796A 2010-07-14 2010-07-14 지속형 인간 성장 호르몬 결합체 액상 제제 Expired - Fee Related KR101337797B1 (ko)

Priority Applications (15)

Application Number Priority Date Filing Date Title
KR1020100067796A KR101337797B1 (ko) 2010-07-14 2010-07-14 지속형 인간 성장 호르몬 결합체 액상 제제
TW100125060A TWI459961B (zh) 2010-07-14 2011-07-14 長效人類生長激素共軛物之液態配方
JP2013519600A 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
CA2805228A CA2805228C (en) 2010-07-14 2011-07-14 A liquid formulation of long-acting human growth hormone conjugate
CN201180039263.8A CN103068366B (zh) 2010-07-14 2011-07-14 长效人生长激素缀合物的液体制剂
ARP110102545A AR082223A1 (es) 2010-07-14 2011-07-14 Formulacion liquida de un conjugado de hormona del crecimiento humano de efecto prolongado, metodo
AU2011277203A AU2011277203B2 (en) 2010-07-14 2011-07-14 A liquid formulation of long-acting human growth hormone conjugate
ES11807064.8T ES2673022T3 (es) 2010-07-14 2011-07-14 Una formulación líquida de conjugado de hormona de crecimiento humano de acción prolongada
EP11807064.8A EP2593084B1 (en) 2010-07-14 2011-07-14 A liquid formulation of long-acting human growth hormone conjugate
PCT/KR2011/005194 WO2012008779A2 (en) 2010-07-14 2011-07-14 A liquid formulation of long-acting human growth hormone conjugate
US13/809,783 US9061072B2 (en) 2010-07-14 2011-07-14 Liquid formulation of long-acting human growth hormone conjugate
RU2013106276A RU2623026C2 (ru) 2010-07-14 2011-07-14 Жидкий состав конъюгата гормона роста человека пролонгированного действия
BR112013000902-0A BR112013000902A2 (pt) 2010-07-14 2011-07-14 formulação líquida de conjugado de hormônio do crescimento humano de longa ação
IL224225A IL224225B (en) 2010-07-14 2013-01-14 Liquid formulation of long-acting human growth hormone conjugate
ARP180100643A AR113034A2 (es) 2010-07-14 2018-03-20 Formulación líquida de un conjugado de la hormona del crecimiento humano de efecto prolongado

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
KR1020100067796A KR101337797B1 (ko) 2010-07-14 2010-07-14 지속형 인간 성장 호르몬 결합체 액상 제제

Publications (2)

Publication Number Publication Date
KR20120007182A KR20120007182A (ko) 2012-01-20
KR101337797B1 true KR101337797B1 (ko) 2013-12-06

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KR1020100067796A Expired - Fee Related KR101337797B1 (ko) 2010-07-14 2010-07-14 지속형 인간 성장 호르몬 결합체 액상 제제

Country Status (13)

Country Link
US (1) US9061072B2 (cg-RX-API-DMAC10.html)
EP (1) EP2593084B1 (cg-RX-API-DMAC10.html)
JP (1) JP5946448B2 (cg-RX-API-DMAC10.html)
KR (1) KR101337797B1 (cg-RX-API-DMAC10.html)
AR (2) AR082223A1 (cg-RX-API-DMAC10.html)
AU (1) AU2011277203B2 (cg-RX-API-DMAC10.html)
BR (1) BR112013000902A2 (cg-RX-API-DMAC10.html)
CA (1) CA2805228C (cg-RX-API-DMAC10.html)
ES (1) ES2673022T3 (cg-RX-API-DMAC10.html)
IL (1) IL224225B (cg-RX-API-DMAC10.html)
RU (1) RU2623026C2 (cg-RX-API-DMAC10.html)
TW (1) TWI459961B (cg-RX-API-DMAC10.html)
WO (1) WO2012008779A2 (cg-RX-API-DMAC10.html)

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KR100725315B1 (ko) * 2003-11-13 2007-06-07 한미약품 주식회사 면역글로불린 단편을 이용한 단백질 결합체 및 그의제조방법

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Publication number Publication date
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
CA2805228C (en) 2019-05-07
AR082223A1 (es) 2012-11-21
EP2593084A4 (en) 2014-11-05
KR20120007182A (ko) 2012-01-20

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