KR102276304B1 - 지속형 인간 성장 호르몬 제제 - Google Patents

지속형 인간 성장 호르몬 제제 Download PDF

Info

Publication number
KR102276304B1
KR102276304B1 KR1020140129476A KR20140129476A KR102276304B1 KR 102276304 B1 KR102276304 B1 KR 102276304B1 KR 1020140129476 A KR1020140129476 A KR 1020140129476A KR 20140129476 A KR20140129476 A KR 20140129476A KR 102276304 B1 KR102276304 B1 KR 102276304B1
Authority
KR
South Korea
Prior art keywords
long
growth hormone
human growth
formulation
conjugate
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.)
Active
Application number
KR1020140129476A
Other languages
English (en)
Korean (ko)
Other versions
KR20150035681A (ko
Inventor
임화평
김현욱
임호택
김상윤
임형규
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
Application filed by 한미약품 주식회사 filed Critical 한미약품 주식회사
Publication of KR20150035681A publication Critical patent/KR20150035681A/ko
Application granted granted Critical
Publication of KR102276304B1 publication Critical patent/KR102276304B1/ko
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

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
    • A61K47/06—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/6835—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 the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6883—Polymer-drug antibody conjugates, e.g. mitomycin-dextran-Ab; DNA-polylysine-antibody complex or conjugate used for therapy
    • 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
    • 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
    • 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
    • A61P5/10—Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Biotechnology (AREA)
  • Dermatology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
KR1020140129476A 2013-09-27 2014-09-26 지속형 인간 성장 호르몬 제제 Active KR102276304B1 (ko)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020130115177 2013-09-27
KR20130115177 2013-09-27

Publications (2)

Publication Number Publication Date
KR20150035681A KR20150035681A (ko) 2015-04-07
KR102276304B1 true KR102276304B1 (ko) 2021-07-14

Family

ID=52743982

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020140129476A Active KR102276304B1 (ko) 2013-09-27 2014-09-26 지속형 인간 성장 호르몬 제제

Country Status (15)

Country Link
US (2) US10987425B2 (enExample)
EP (2) EP3050559B1 (enExample)
JP (1) JP6549104B2 (enExample)
KR (1) KR102276304B1 (enExample)
CN (2) CN105848645A (enExample)
AR (1) AR097840A1 (enExample)
AU (1) AU2014329003A1 (enExample)
BR (1) BR112016006455A2 (enExample)
CA (1) CA2925416A1 (enExample)
HK (1) HK1225976A1 (enExample)
IL (1) IL244769A0 (enExample)
MX (1) MX2016003705A (enExample)
RU (1) RU2683823C2 (enExample)
TW (1) TW201605468A (enExample)
WO (1) WO2015046974A1 (enExample)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
DK3127923T3 (da) * 2014-03-31 2021-11-22 Hanmi Pharm Ind Co Ltd Fremgangsmåde til forbedring af oppløselighed af protein og peptid ved hjælp af immunoglobulin-fc-fragment-binding
KR101808234B1 (ko) 2015-06-23 2017-12-12 (주)알테오젠 IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제
KR20170079409A (ko) * 2015-12-30 2017-07-10 한미약품 주식회사 지속형 인간 성장 호르몬 결합체의 신규 액상 제제
CN106256835A (zh) * 2016-08-19 2016-12-28 安源医药科技（上海）有限公司 高糖基化人生长激素融合蛋白及其制备方法与用途
KR101861163B1 (ko) 2017-04-26 2018-05-25 삼천당제약주식회사 안과용 약학 조성물
IL298396A (en) * 2020-05-22 2023-01-01 Hanmi Pharm Ind Co Ltd Liquid formulation of long-acting conjugate of glucagon derivative
CN115845032A (zh) * 2022-10-28 2023-03-28 深圳科兴药业有限公司 生长激素fc融合蛋白注射液及其用途

Family Cites Families (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE9201073D0 (sv) * 1992-04-03 1992-04-03 Kabi Pharmacia Ab Protein formulation
FR2719479B1 (fr) * 1994-05-04 1996-07-26 Sanofi Elf Formulation stable lyophilisée comprenant une protéine: kit de dosage.
US6096871A (en) 1995-04-14 2000-08-01 Genentech, Inc. Polypeptides altered to contain an epitope from the Fc region of an IgG molecule for increased half-life
ZA966075B (en) 1995-07-27 1998-01-19 Genentech Inc Protein formulation.
JPH10265404A (ja) * 1996-02-02 1998-10-06 Mitsui Chem Inc ヒト成長ホルモンを含有する医薬製剤
AUPN801296A0 (en) * 1996-02-12 1996-03-07 Csl Limited Stabilised growth hormone formulation and method of preparation thereof
WO1997034631A1 (en) 1996-03-18 1997-09-25 Board Of Regents, The University Of Texas System Immunoglobin-like domains with increased half lives
US20020077461A1 (en) * 1996-04-24 2002-06-20 Soren Bjorn Pharmaceutical formulation
US20070179096A1 (en) 1996-04-24 2007-08-02 Novo Nordisk A/S Pharmaceutical Formulation
SE9704405D0 (sv) * 1997-11-28 1997-11-28 Pharmacia & Upjohn Ab New syringe
RU2190129C2 (ru) 2000-10-17 2002-09-27 Открытое акционерное общество "Павловский машиностроительный завод "Восход" Резервированный электрогидравлический привод
ATE454137T1 (de) * 2001-07-25 2010-01-15 Facet Biotech Corp Stabile lyophilisierte pharmazeutische formulierung des igg-antikörpers daclizumab
US20050176108A1 (en) 2003-03-13 2005-08-11 Young-Min Kim Physiologically active polypeptide conjugate having prolonged in vivo half-life
BRPI0406606A (pt) 2003-11-13 2005-12-06 Hanmi Pharm Ind Co Ltd Composição farmacêutica compreendendo uma região fc de imunoglobulina como um veìculo
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
CA2594561C (en) 2004-12-22 2014-12-23 Ambrx, Inc. Formulations of human growth hormone comprising a non-naturally encoded amino acid
JP4283776B2 (ja) * 2005-03-07 2009-06-24 ラボラトワール セローノ ソシエテ アノニム Ｈｇｈ含有医薬組成物
KR100754667B1 (ko) * 2005-04-08 2007-09-03 한미약품 주식회사 비펩타이드성 중합체로 개질된 면역글로불린 Ｆｃ 단편 및이를 포함하는 약제학적 조성물
EP1916997B1 (en) * 2005-08-05 2018-04-18 Amgen Inc. Stable aqueous protein pharmaceutical formulations and their preparation
HRP20140172T1 (hr) * 2006-05-30 2014-03-28 Genentech, Inc. Protutijela i imunokonjugati kao i njihove uporabe
SG181648A1 (en) * 2009-12-15 2012-07-30 Ascendis Pharma As Dry growth hormone composition transiently linked to a polymer carrier
KR101337797B1 (ko) * 2010-07-14 2013-12-06 한미사이언스 주식회사 지속형 인간 성장 호르몬 결합체 액상 제제
EP2606908A1 (en) * 2011-12-19 2013-06-26 Ipsen Pharma S.A.S. Novel pharmaceutical composition for a long acting growth hormone fusion protein (LAGH)
US10064951B2 (en) * 2012-03-30 2018-09-04 Hanmi Science Co., Ltd. Liquid formulation of highly concentrated long-acting human growth hormone conjugate

Also Published As

Publication number Publication date
RU2016113684A (ru) 2017-11-01
US10987425B2 (en) 2021-04-27
EP3050559B1 (en) 2020-06-03
TW201605468A (zh) 2016-02-16
US20160213789A1 (en) 2016-07-28
US12274750B2 (en) 2025-04-15
MX2016003705A (es) 2016-05-16
AR097840A1 (es) 2016-04-20
HK1225976A1 (en) 2017-09-22
IL244769A0 (en) 2016-04-21
EP3689335A1 (en) 2020-08-05
WO2015046974A1 (ko) 2015-04-02
KR20150035681A (ko) 2015-04-07
BR112016006455A2 (pt) 2017-08-01
US20210138070A1 (en) 2021-05-13
JP6549104B2 (ja) 2019-07-24
EP3050559A4 (en) 2017-05-31
CN105848645A (zh) 2016-08-10
CA2925416A1 (en) 2015-04-02
AU2014329003A1 (en) 2016-05-12
EP3050559A1 (en) 2016-08-03
JP2016533345A (ja) 2016-10-27
CN114288254A (zh) 2022-04-08
RU2016113684A3 (enExample) 2018-06-28
RU2683823C2 (ru) 2019-04-02

Similar Documents

Publication Publication Date Title
KR102276304B1 (ko) 지속형 인간 성장 호르몬 제제
EP2593084B1 (en) A liquid formulation of long-acting human growth hormone conjugate
US20180344866A1 (en) Liquid formulation of highly concentrated long-acting human growth hormone conjugate
US20190022183A1 (en) A novel liquid formulation of long-acting human growth hormone conjugate
CN103068366B (zh) 长效人生长激素缀合物的液体制剂

Legal Events

Date Code Title Description
PA0109 Patent application

Patent event code: PA01091R01D

Comment text: Patent Application

Patent event date: 20140926

PG1501 Laying open of application
PA0201 Request for examination

Patent event code: PA02012R01D

Patent event date: 20190920

Comment text: Request for Examination of Application

Patent event code: PA02011R01I

Patent event date: 20140926

Comment text: Patent Application

E902 Notification of reason for refusal
PE0902 Notice of grounds for rejection

Comment text: Notification of reason for refusal

Patent event date: 20210216

Patent event code: PE09021S01D

E701 Decision to grant or registration of patent right
PE0701 Decision of registration

Patent event code: PE07011S01D

Comment text: Decision to Grant Registration

Patent event date: 20210701

GRNT Written decision to grant
PR0701 Registration of establishment

Comment text: Registration of Establishment

Patent event date: 20210706

Patent event code: PR07011E01D

PR1002 Payment of registration fee

Payment date: 20210707

End annual number: 3

Start annual number: 1

PG1601 Publication of registration
PR1001 Payment of annual fee

Payment date: 20240617

Start annual number: 4

End annual number: 4

PR1001 Payment of annual fee

Payment date: 20250616

Start annual number: 5

End annual number: 5