CA2805228C - 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
CA2805228C
CA2805228C CA2805228A CA2805228A CA2805228C CA 2805228 C CA2805228 C CA 2805228C CA 2805228 A CA2805228 A CA 2805228A CA 2805228 A CA2805228 A CA 2805228A CA 2805228 C CA2805228 C CA 2805228C
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CA
Canada
Prior art keywords
long
growth hormone
human growth
liquid formulation
acting
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.)
Expired - Fee Related
Application number
CA2805228A
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English (en)
French (fr)
Other versions
CA2805228A1 (en
Inventor
Sung Hee Hong
Byung Sun Lee
Dae Seong Im
Jae Min Lee
Sung Min Bae
Se Chang Kwon
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hanmi Science Co Ltd
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Hanmi Science Co Ltd
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
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Publication of CA2805228A1 publication Critical patent/CA2805228A1/en
Application granted granted Critical
Publication of CA2805228C publication Critical patent/CA2805228C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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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

Landscapes

  • 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)
CA2805228A 2010-07-14 2011-07-14 A liquid formulation of long-acting human growth hormone conjugate Expired - Fee Related CA2805228C (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
CA2805228A1 CA2805228A1 (en) 2012-01-19
CA2805228C true CA2805228C (en) 2019-05-07

Family

ID=45469941

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2805228A Expired - Fee Related CA2805228C (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 (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
PL2916819T3 (pl) * 2012-11-06 2020-01-31 Hanmi Pharm. Co., Ltd. Płynna formuła koniugatu białka zawierająca oksyntomodulinę i fragment immunoglobulinowy
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
TW201513880A (zh) 2013-03-11 2015-04-16 Novo Nordisk As 生長激素化合物
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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
HK1225976A1 (en) * 2013-09-27 2017-09-22 Hanmi Pharm. Co., Ltd. Sustained type human growth hormone preparation
EP3127923B1 (en) * 2014-03-31 2021-08-18 Hanmi Pharm. Co., Ltd. Method for improving solubility of protein and peptide by using immunoglobulin fc fragment linkage
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AU2015358890B2 (en) 2014-12-10 2019-06-13 Opko Biologics Ltd. Methods of producing long acting CTP-modified growth hormone polypeptides
KR102418477B1 (ko) 2014-12-30 2022-07-08 한미약품 주식회사 글루카곤 유도체
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KR20180051543A (ko) * 2015-09-11 2018-05-16 다우 글로벌 테크놀로지스 엘엘씨 단백질 및 폴리알콕시 지방 화합물을 포함하는 조성물
TWI841908B (zh) * 2015-09-24 2024-05-11 美商拜奧馬林製藥公司 腺相關病毒因子viii載體、相關病毒粒子及包含其之治療調配物
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CN110505885A (zh) 2017-04-05 2019-11-26 诺和诺德股份有限公司 寡聚体延伸的胰岛素-Fc缀合物
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Also Published As

Publication number Publication date
RU2623026C2 (ru) 2017-06-21
TWI459961B (zh) 2014-11-11
US20130115231A1 (en) 2013-05-09
IL224225B (en) 2018-07-31
EP2593084A4 (en) 2014-11-05
BR112013000902A2 (pt) 2020-08-25
AU2011277203A1 (en) 2013-02-28
JP2013531034A (ja) 2013-08-01
JP5946448B2 (ja) 2016-07-06
AU2011277203B2 (en) 2015-11-12
AR113034A2 (es) 2020-01-22
US9061072B2 (en) 2015-06-23
RU2013106276A (ru) 2014-08-20
KR101337797B1 (ko) 2013-12-06
AR082223A1 (es) 2012-11-21
EP2593084A2 (en) 2013-05-22
EP2593084B1 (en) 2018-03-14
KR20120007182A (ko) 2012-01-20
WO2012008779A3 (en) 2012-05-24
ES2673022T3 (es) 2018-06-19
CN103068366A (zh) 2013-04-24
CA2805228A1 (en) 2012-01-19
TW201215404A (en) 2012-04-16
WO2012008779A2 (en) 2012-01-19

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