WO2017116191A3 - 지속형 인간 성장 호르몬 결합체의 신규 액상 제제 - Google Patents

지속형 인간 성장 호르몬 결합체의 신규 액상 제제 Download PDF

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Publication number
WO2017116191A3
WO2017116191A3 PCT/KR2016/015534 KR2016015534W WO2017116191A3 WO 2017116191 A3 WO2017116191 A3 WO 2017116191A3 KR 2016015534 W KR2016015534 W KR 2016015534W WO 2017116191 A3 WO2017116191 A3 WO 2017116191A3
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WO
WIPO (PCT)
Prior art keywords
long
growth hormone
human growth
phase preparation
novel liquid
Prior art date
Application number
PCT/KR2016/015534
Other languages
English (en)
French (fr)
Other versions
WO2017116191A2 (ko
Inventor
임형규
동주영
배성민
권세창
Original Assignee
한미약품 주식회사
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority to RU2018125963A priority Critical patent/RU2018125963A/ru
Application filed by 한미약품 주식회사 filed Critical 한미약품 주식회사
Priority to MX2018008026A priority patent/MX2018008026A/es
Priority to CN201680081848.9A priority patent/CN108697642A/zh
Priority to CA3009627A priority patent/CA3009627A1/en
Priority to BR112018013535-6A priority patent/BR112018013535A2/pt
Priority to EP16882143.7A priority patent/EP3398586A4/en
Priority to AU2016382383A priority patent/AU2016382383A1/en
Priority to US16/066,877 priority patent/US20190022183A1/en
Priority to JP2018534559A priority patent/JP2019500390A/ja
Publication of WO2017116191A2 publication Critical patent/WO2017116191A2/ko
Publication of WO2017116191A3 publication Critical patent/WO2017116191A3/ko
Priority to IL260316A priority patent/IL260316A/en
Priority to HK19100601.0A priority patent/HK1258240A1/zh

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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
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1796—Receptors; Cell surface antigens; Cell surface determinants for hormones
    • 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
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1774—Immunoglobulin superfamily (e.g. CD2, CD4, CD8, ICAM molecules, B7 molecules, Fc-receptors, MHC-molecules)
    • 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
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1793—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • 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
    • 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
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • 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
    • A61K47/6889—Conjugates wherein the antibody being the modifying agent and wherein the linker, binder or spacer confers particular properties to the conjugates, e.g. peptidic enzyme-labile linkers or acid-labile linkers, providing for an acid-labile immuno conjugate wherein the drug may be released from its antibody conjugated part in an acidic, e.g. tumoural or environment
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Endocrinology (AREA)
  • Cell Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Peptides Or Proteins (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Toxicology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)

Abstract

본 발명은 지속형 인간 성장 호르몬 결합체의 액상 제제 및 이의 제조 방법에 관한 것이다.
PCT/KR2016/015534 2015-12-30 2016-12-30 지속형 인간 성장 호르몬 결합체의 신규 액상 제제 WO2017116191A2 (ko)

Priority Applications (11)

Application Number Priority Date Filing Date Title
EP16882143.7A EP3398586A4 (en) 2015-12-30 2016-12-30 NOVEL LIQUID PHASE PREPARATION FROM HUMAN GROWTH HORMONE CONJUGATE
MX2018008026A MX2018008026A (es) 2015-12-30 2016-12-30 Una formulacion de conjugado de crecimiento humano de accion prolongada.
CN201680081848.9A CN108697642A (zh) 2015-12-30 2016-12-30 新型长效人生长激素缀合物液体制剂
CA3009627A CA3009627A1 (en) 2015-12-30 2016-12-30 A novel liquid formulation of long-acting human growth hormone conjugate
BR112018013535-6A BR112018013535A2 (pt) 2015-12-30 2016-12-30 ?formulação líquida inovadora de conjugado de hormônio de crescimento humano de atuação longa e seu método de preparo?
RU2018125963A RU2018125963A (ru) 2015-12-30 2016-12-30 Новая жидкая композиция конъюгата человеческого гормона роста длительного действия
AU2016382383A AU2016382383A1 (en) 2015-12-30 2016-12-30 A novel liquid formulation of long-acting human growth hormone conjugate
US16/066,877 US20190022183A1 (en) 2015-12-30 2016-12-30 A novel liquid formulation of long-acting human growth hormone conjugate
JP2018534559A JP2019500390A (ja) 2015-12-30 2016-12-30 持続型ヒト成長ホルモン結合体の新規液状製剤
IL260316A IL260316A (en) 2015-12-30 2018-06-27 A novel liquid formulation of long-acting human growth hormone conjugate
HK19100601.0A HK1258240A1 (zh) 2015-12-30 2019-01-14 新型長效人生長激素綴合物液體製劑

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR10-2015-0189919 2015-12-30
KR1020150189919A KR20170079409A (ko) 2015-12-30 2015-12-30 지속형 인간 성장 호르몬 결합체의 신규 액상 제제

Publications (2)

Publication Number Publication Date
WO2017116191A2 WO2017116191A2 (ko) 2017-07-06
WO2017116191A3 true WO2017116191A3 (ko) 2018-03-08

Family

ID=59227383

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2016/015534 WO2017116191A2 (ko) 2015-12-30 2016-12-30 지속형 인간 성장 호르몬 결합체의 신규 액상 제제

Country Status (15)

Country Link
US (1) US20190022183A1 (ko)
EP (1) EP3398586A4 (ko)
JP (1) JP2019500390A (ko)
KR (1) KR20170079409A (ko)
CN (1) CN108697642A (ko)
AR (1) AR107276A1 (ko)
AU (1) AU2016382383A1 (ko)
BR (1) BR112018013535A2 (ko)
CA (1) CA3009627A1 (ko)
HK (1) HK1258240A1 (ko)
IL (1) IL260316A (ko)
MX (1) MX2018008026A (ko)
RU (1) RU2018125963A (ko)
TW (1) TW201735940A (ko)
WO (1) WO2017116191A2 (ko)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20220054586A1 (en) * 2018-09-10 2022-02-24 Samsung Bioepis Co., Ltd. Liquid composition comprising protein
KR20220095204A (ko) * 2019-10-30 2022-07-06 제이씨알 파마 가부시키가이샤 혈청 알부민과 성장 호르몬의 융합 단백질을 함유하는 수성 의약 조성물

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20020064141A (ko) * 1999-05-31 2002-08-07 미쯔비시 가가꾸 가부시끼가이샤 간실질세포 증식인자 동결건조 제제
WO2009080164A1 (en) * 2007-12-21 2009-07-02 Merck Patent Gmbh Solid lipid microcapsules containing growth hormone in the inner solid core
KR20120007182A (ko) * 2010-07-14 2012-01-20 한미홀딩스 주식회사 지속형 인간 성장 호르몬 결합체 액상 제제
KR20130111462A (ko) * 2012-03-30 2013-10-10 한미사이언스 주식회사 지속형 인간 성장 호르몬의 고농도 액상 제제
KR20150035681A (ko) * 2013-09-27 2015-04-07 한미약품 주식회사 지속형 인간 성장 호르몬 제제

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE522548T1 (de) * 2003-11-13 2011-09-15 Hanmi Holdings Co Ltd Verfahren zur massenproduktion der konstanten region von immunglobulin

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20020064141A (ko) * 1999-05-31 2002-08-07 미쯔비시 가가꾸 가부시끼가이샤 간실질세포 증식인자 동결건조 제제
WO2009080164A1 (en) * 2007-12-21 2009-07-02 Merck Patent Gmbh Solid lipid microcapsules containing growth hormone in the inner solid core
KR20120007182A (ko) * 2010-07-14 2012-01-20 한미홀딩스 주식회사 지속형 인간 성장 호르몬 결합체 액상 제제
KR20130111462A (ko) * 2012-03-30 2013-10-10 한미사이언스 주식회사 지속형 인간 성장 호르몬의 고농도 액상 제제
KR20150035681A (ko) * 2013-09-27 2015-04-07 한미약품 주식회사 지속형 인간 성장 호르몬 제제

Also Published As

Publication number Publication date
AR107276A1 (es) 2018-04-11
IL260316A (en) 2019-02-28
AU2016382383A1 (en) 2018-07-26
CA3009627A1 (en) 2017-07-06
EP3398586A4 (en) 2019-08-07
CN108697642A (zh) 2018-10-23
HK1258240A1 (zh) 2019-11-08
RU2018125963A (ru) 2020-01-30
MX2018008026A (es) 2018-11-29
TW201735940A (zh) 2017-10-16
BR112018013535A2 (pt) 2018-12-04
KR20170079409A (ko) 2017-07-10
US20190022183A1 (en) 2019-01-24
JP2019500390A (ja) 2019-01-10
EP3398586A2 (en) 2018-11-07
WO2017116191A2 (ko) 2017-07-06

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