EA201590758A1 - Жидкая композиция белкового конъюгата, содержащего оксинтомодулин и фрагмент иммуноглобулина - Google Patents

Жидкая композиция белкового конъюгата, содержащего оксинтомодулин и фрагмент иммуноглобулина

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Publication number
EA201590758A1
EA201590758A1 EA201590758A EA201590758A EA201590758A1 EA 201590758 A1 EA201590758 A1 EA 201590758A1 EA 201590758 A EA201590758 A EA 201590758A EA 201590758 A EA201590758 A EA 201590758A EA 201590758 A1 EA201590758 A1 EA 201590758A1
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EA
Eurasian Patent Office
Prior art keywords
oxyntomodulin
oxintomodulin
liquid composition
immunoglobulin
long
Prior art date
Application number
EA201590758A
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English (en)
Other versions
EA031852B1 (ru
Inventor
Хьюн Ок Ким
Хьюнг Кю Лим
Мюн Хюн Джан
Сан Юн Ким
Сан Мин Бэ
Се Чан Квон
Original Assignee
Ханми Фарм. Ко., Лтд.
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Publication date
Application filed by Ханми Фарм. Ко., Лтд. filed Critical Ханми Фарм. Ко., Лтд.
Publication of EA201590758A1 publication Critical patent/EA201590758A1/ru
Publication of EA031852B1 publication Critical patent/EA031852B1/ru

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    • 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
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    • 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
    • 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
    • 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
    • A61K38/26—Glucagons
    • 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
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    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
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    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • A—HUMAN NECESSITIES
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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    • 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
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    • 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
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61K47/6851—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 the antibody targeting a determinant of a tumour cell
    • 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
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/605—Glucagons
    • 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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  • Proteomics, Peptides & Aminoacids (AREA)
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  • Child & Adolescent Psychology (AREA)
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  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Изобретение относится к жидкой композиции, не содержащей альбумин, содержащей конъюгат оксинтомодулина длительного действия, в котором пептид оксинтомодулин, включая производное, вариант, предшественник или фрагмент оксинтомодулина, связан с областью Fc иммуноглобулина, что может увеличивать продолжительность физиологической активности конъюгата оксинтомодулина длительного действия и сохранять его стабильность in vivo в течение длительного периода времени по сравнению с нативным оксинтомодулином, а также к способу получения этой жидкой композиции. Эта жидкая композиция содержит буфер, сахарный спирт и неионогенное поверхностно-активное вещество и не содержит сывороточный альбумин человека и факторы, являющиеся потенциально вредными для организма человека, и, следовательно, нечувствительна к вирусной инфекции. Кроме того, конъюгат оксинтомодулина по изобретению содержит оксинтомодулин, связанный с областью Fc иммуноглобулина, и, следовательно, обладает большой молекулярной массой, длительной физиологической активностью и превосходной стабильностью при хранении по сравнению с нативным оксинтомодулином.
EA201590758A 2012-11-06 2013-11-06 Жидкая композиция белкового конъюгата, содержащего оксинтомодулин и фрагмент иммуноглобулина EA031852B1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20120124725 2012-11-06
PCT/KR2013/009986 WO2014073842A1 (en) 2012-11-06 2013-11-06 Liquid formulation of protein conjugate comprising the oxyntomodulin and an immunoglobulin fragment

Publications (2)

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EA201590758A1 true EA201590758A1 (ru) 2015-10-30
EA031852B1 EA031852B1 (ru) 2019-03-29

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ID=50684883

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Application Number Title Priority Date Filing Date
EA201992760A EA039082B1 (ru) 2012-11-06 2013-11-06 Жидкая композиция белкового конъюгата, содержащего оксинтомодулин и фрагмент иммуноглобулина
EA201590758A EA031852B1 (ru) 2012-11-06 2013-11-06 Жидкая композиция белкового конъюгата, содержащего оксинтомодулин и фрагмент иммуноглобулина
EA201791143A EA034499B1 (ru) 2012-11-06 2013-11-06 Жидкая композиция белкового конъюгата, содержащего оксинтомодулин и фрагмент иммуноглобулина

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EA201992760A EA039082B1 (ru) 2012-11-06 2013-11-06 Жидкая композиция белкового конъюгата, содержащего оксинтомодулин и фрагмент иммуноглобулина

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EA201791143A EA034499B1 (ru) 2012-11-06 2013-11-06 Жидкая композиция белкового конъюгата, содержащего оксинтомодулин и фрагмент иммуноглобулина

Country Status (27)

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US (3) US9724420B2 (ru)
EP (2) EP2916819B1 (ru)
JP (2) JP6363612B2 (ru)
KR (2) KR102311517B1 (ru)
CN (1) CN104884045B (ru)
AR (2) AR093387A1 (ru)
AU (3) AU2013342321B2 (ru)
BR (1) BR112015010235B1 (ru)
CA (1) CA2890324C (ru)
CL (1) CL2015001206A1 (ru)
DK (1) DK2916819T3 (ru)
EA (3) EA039082B1 (ru)
ES (1) ES2748158T3 (ru)
HK (1) HK1210044A1 (ru)
IL (2) IL238626B (ru)
MX (2) MX2015005698A (ru)
MY (2) MY197849A (ru)
NZ (3) NZ739063A (ru)
PE (1) PE20151421A1 (ru)
PH (2) PH12018501454A1 (ru)
PL (1) PL2916819T3 (ru)
PT (1) PT2916819T (ru)
SG (2) SG10201602801YA (ru)
TW (3) TWI602583B (ru)
UA (2) UA116364C2 (ru)
WO (1) WO2014073842A1 (ru)
ZA (1) ZA201503998B (ru)

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