EA202092623A1 - СТАБИЛЬНЫЙ СОСТАВ НА ОСНОВЕ G-CSF, СЛИТОГО С ГИБРИДНЫМ Fc - Google Patents

СТАБИЛЬНЫЙ СОСТАВ НА ОСНОВЕ G-CSF, СЛИТОГО С ГИБРИДНЫМ Fc

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Publication number
EA202092623A1
EA202092623A1 EA202092623A EA202092623A EA202092623A1 EA 202092623 A1 EA202092623 A1 EA 202092623A1 EA 202092623 A EA202092623 A EA 202092623A EA 202092623 A EA202092623 A EA 202092623A EA 202092623 A1 EA202092623 A1 EA 202092623A1
Authority
EA
Eurasian Patent Office
Prior art keywords
hybrid
csf
fused
composition based
stable composition
Prior art date
Application number
EA202092623A
Other languages
English (en)
Inventor
Хатидже Онджель
Йилмаз Чапан
Дуйгу Дагликоджа
Хурие Эрдоган Дагдаш
Адем Шахин
Мельтем Горбаджлу
Айлин Озкан
Нагехан Саррачоглу
Original Assignee
Илькоген Илач Санайи Ве Тиджарет А.Ш.
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 Илькоген Илач Санайи Ве Тиджарет А.Ш. filed Critical Илькоген Илач Санайи Ве Тиджарет А.Ш.
Publication of EA202092623A1 publication Critical patent/EA202092623A1/ru

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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
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/193—Colony stimulating factors [CSF]
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/68—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
    • A61K47/6813—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin the drug being a peptidic cytokine, e.g. an interleukin or interferon
    • 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

Landscapes

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

Abstract

Настоящее изобретение предусматривает подходящую для введения, осуществляемого подкожным (п/к) путем, стабильную форму состава на основе гранулоцитарного колониестимулирующего фактора (G-CSF), слитого с гибридным Fc, содержащего (i) терапевтически эффективное количество G-CSF, слитого с гибридным Fc, (ii) буферную систему, (iii) по меньшей мере один стабилизатор, (iv) по меньшей мере одно поверхностно-активное вещество и (v) необязательно пропиленгликоль в качестве органического растворителя.
EA202092623A 2018-05-04 2018-05-04 СТАБИЛЬНЫЙ СОСТАВ НА ОСНОВЕ G-CSF, СЛИТОГО С ГИБРИДНЫМ Fc EA202092623A1 (ru)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/TR2018/050208 WO2019212429A2 (en) 2018-05-04 2018-05-04 Stable hybrid fc fusion g-csf formulation

Publications (1)

Publication Number Publication Date
EA202092623A1 true EA202092623A1 (ru) 2021-02-01

Family

ID=66752171

Family Applications (1)

Application Number Title Priority Date Filing Date
EA202092623A EA202092623A1 (ru) 2018-05-04 2018-05-04 СТАБИЛЬНЫЙ СОСТАВ НА ОСНОВЕ G-CSF, СЛИТОГО С ГИБРИДНЫМ Fc

Country Status (6)

Country Link
US (1) US20210121529A1 (ru)
EP (1) EP3773468A2 (ru)
KR (1) KR102589578B1 (ru)
CN (1) CN112312890A (ru)
EA (1) EA202092623A1 (ru)
WO (1) WO2019212429A2 (ru)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2020220651A1 (en) 2019-02-13 2021-09-09 Ilkogen Ilac Sanayi Ve Ticaret A.S. A long-acting G-CSF for preventing neutropenia or reducing duration of neutropenia
WO2024037633A2 (en) * 2022-08-19 2024-02-22 Evive Biotechnology (Shanghai) Ltd Formulations comprising g-csf and uses thereof

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB8504099D0 (en) 1985-02-18 1985-03-20 Wellcome Found Physiologically active substances
US7208473B2 (en) 1999-01-06 2007-04-24 Xencor, Inc. Nucleic acids and protein variants of hG-CSF with granulopoietic activity
US6797493B2 (en) * 2001-10-01 2004-09-28 Lee-Hwei K. Sun Fc fusion proteins of human granulocyte colony-stimulating factor with increased biological activities
EP1572936A2 (en) * 2002-03-05 2005-09-14 Eli Lilly And Company Heterologous g-csf fusion proteins
EP3173484B1 (en) 2007-05-30 2018-09-26 Postech Academy-Industry- Foundation Immunoglobulin fusion proteins
RS53404B (en) * 2007-08-27 2014-10-31 Ratiopharm Gmbh LIQUID FORMULATION OF G-CSF CONJUGATES
CN107412737A (zh) * 2010-01-19 2017-12-01 韩美科学株式会社 长效g‑csf缀合物的液体制剂
UY34105A (es) * 2011-06-03 2012-07-31 Lg Life Sciences Ltd Formulación líquida estable de etanercept
US20160362473A1 (en) * 2015-06-12 2016-12-15 Ubi Pharma Inc Immunoglobulin fusion proteins and uses thereof

Also Published As

Publication number Publication date
WO2019212429A2 (en) 2019-11-07
KR20210005721A (ko) 2021-01-14
US20210121529A1 (en) 2021-04-29
KR102589578B1 (ko) 2023-10-17
CN112312890A (zh) 2021-02-02
WO2019212429A3 (en) 2020-03-12
EP3773468A2 (en) 2021-02-17

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