AU2011277203B2 - 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
AU2011277203B2
AU2011277203B2 AU2011277203A AU2011277203A AU2011277203B2 AU 2011277203 B2 AU2011277203 B2 AU 2011277203B2 AU 2011277203 A AU2011277203 A AU 2011277203A AU 2011277203 A AU2011277203 A AU 2011277203A AU 2011277203 B2 AU2011277203 B2 AU 2011277203B2
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AU
Australia
Prior art keywords
long
growth hormone
human growth
liquid formulation
acting
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Ceased
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AU2011277203A
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English (en)
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AU2011277203A1 (en
Inventor
Sung Min Bae
Sung Hee Hong
Dae Seong Im
Se Chang Kwon
Byung Sun Lee
Jae Min Lee
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Hanmi Science Co Ltd
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Hanmi Science Co Ltd
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Publication of AU2011277203A1 publication Critical patent/AU2011277203A1/en
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Publication of AU2011277203B2 publication Critical patent/AU2011277203B2/en
Ceased legal-status Critical Current
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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

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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)
AU2011277203A 2010-07-14 2011-07-14 A liquid formulation of long-acting human growth hormone conjugate Ceased AU2011277203B2 (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
AU2011277203A1 AU2011277203A1 (en) 2013-02-28
AU2011277203B2 true AU2011277203B2 (en) 2015-11-12

Family

ID=45469941

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2011277203A Ceased AU2011277203B2 (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 (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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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
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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
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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
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KR20070025315A (ko) * 2005-09-01 2007-03-08 삼성전자주식회사 화상형성시스템 및 화상 형성 방법
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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
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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