PT2525787T - Formulações líquidas para conjugado de g-csf de longa ação - Google Patents

Formulações líquidas para conjugado de g-csf de longa ação

Info

Publication number
PT2525787T
PT2525787T PT117348540T PT11734854T PT2525787T PT 2525787 T PT2525787 T PT 2525787T PT 117348540 T PT117348540 T PT 117348540T PT 11734854 T PT11734854 T PT 11734854T PT 2525787 T PT2525787 T PT 2525787T
Authority
PT
Portugal
Prior art keywords
acting
long
liquid formulations
csf conjugate
csf
Prior art date
Application number
PT117348540T
Other languages
English (en)
Inventor
Chang Kwon Se
Min Bae Sung
Min Lee Jae
Ji Lee Mi
Sun Lee Byung
Original Assignee
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=44307381&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PT2525787(T) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Hanmi Science Co Ltd filed Critical Hanmi Science Co Ltd
Publication of PT2525787T publication Critical patent/PT2525787T/pt

Links

Classifications

    • 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
    • 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
    • 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
    • A61K47/06—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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • 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
    • 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • C07K14/52—Cytokines; Lymphokines; Interferons
    • C07K14/53—Colony-stimulating factor [CSF]
    • C07K14/535—Granulocyte CSF; Granulocyte-macrophage CSF

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biochemistry (AREA)
  • Toxicology (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
PT117348540T 2010-01-19 2011-01-18 Formulações líquidas para conjugado de g-csf de longa ação PT2525787T (pt)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
KR20100004839 2010-01-19

Publications (1)

Publication Number Publication Date
PT2525787T true PT2525787T (pt) 2017-12-18

Family

ID=44307381

Family Applications (1)

Application Number Title Priority Date Filing Date
PT117348540T PT2525787T (pt) 2010-01-19 2011-01-18 Formulações líquidas para conjugado de g-csf de longa ação

Country Status (17)

Country Link
US (1) US9867777B2 (pt)
EP (1) EP2525787B1 (pt)
JP (2) JP5657698B2 (pt)
KR (1) KR101340710B1 (pt)
CN (2) CN102740840A (pt)
AR (1) AR080427A1 (pt)
AU (1) AU2011207915B2 (pt)
BR (1) BR112012017979B1 (pt)
CA (1) CA2787648C (pt)
ES (1) ES2654102T3 (pt)
HK (1) HK1246190A1 (pt)
HU (1) HUE034398T2 (pt)
MX (1) MX340463B (pt)
PT (1) PT2525787T (pt)
RU (1) RU2519031C1 (pt)
TW (1) TWI409082B (pt)
WO (1) WO2011090305A2 (pt)

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RU2519031C1 (ru) 2010-01-19 2014-06-10 Ханми Сайенс Ко., Лтд. Жидкие препаративные формы для длительно действующего конъюгата g-csf
TWI480288B (zh) * 2010-09-23 2015-04-11 Lilly Co Eli 牛顆粒細胞群落刺激因子及其變體之調配物
KR101303388B1 (ko) * 2010-10-26 2013-09-03 한미사이언스 주식회사 지속형 인터페론 알파 결합체의 액상 제제
EP2635310A2 (en) 2010-11-05 2013-09-11 Rinat Neuroscience Corp. Engineered polypeptide conjugates and methods for making thereof using transglutaminase
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
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
WO2014132139A2 (en) * 2013-01-19 2014-09-04 Avalance Biotech Ab Methods to fabricate, modify, remove and utilize fluid membranes
KR20150126042A (ko) 2013-03-12 2015-11-10 다이닛본 스미토모 세이야꾸 가부시끼가이샤 액체 수성 조성물
EP3027224B1 (en) 2013-07-31 2020-06-03 Rinat Neuroscience Corp. Engineered polypeptide conjugates using transglutaminase
US20170128589A1 (en) * 2014-03-31 2017-05-11 Hanmi Pharm. Co., Ltd. Method for improving solubility of protein and peptide by using immunoglogulin fc fragment linkage
RU2674979C2 (ru) 2014-04-25 2018-12-14 Ринат Ньюросайенс Корп. Конъюгаты "антитело - лекарственное средство" с высокой лекарственной нагрузкой
KR102495153B1 (ko) 2015-09-14 2023-02-01 다이오세이시가부시끼가이샤 지관 및 당해 지관을 사용한 롤상 시트
CN105311625A (zh) * 2015-11-23 2016-02-10 哈药集团生物工程有限公司 一种含有重组人粒细胞刺激因子的药物组合物
CN107446044B (zh) * 2016-05-30 2021-04-30 越海百奥药业(绍兴)有限公司 一种纯化抗体的方法及所用缓冲液
AU2018348138A1 (en) * 2017-10-11 2020-04-23 Ambrx, Inc. Porcine G-CSF variants and their uses
WO2019212429A2 (en) * 2018-05-04 2019-11-07 İlkogen İlaç Sanayi̇ Ve Ti̇caret A.Ş. Stable hybrid fc fusion g-csf formulation
BR112021015428A2 (pt) * 2019-02-13 2022-02-15 Ilkogen Ilac Sanayi Ve Ticaret A S Uma fc híbrida de fusão g-csf para prevenir neutropenia ou reduzir a duração da neutropenia
EP3744319B1 (en) * 2019-05-28 2022-10-19 Ilkogen Ilac Sanayi Ve Ticaret A.S. A stable lyophilized formulation for hybrid fc fused g-csf
US11267858B2 (en) * 2019-05-31 2022-03-08 Spectrum Pharmaceuticals, Inc. Methods of treatment using G-CSF protein complex
US11684655B2 (en) 2019-05-31 2023-06-27 Spectrum Pharmaceuticals, Inc. Methods of treating neutorpenia using G-CSF protein complex
KR102375269B1 (ko) * 2021-01-27 2022-03-17 한미약품 주식회사 단백질 액상 제제 및 이의 제조방법

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RU2519031C1 (ru) 2010-01-19 2014-06-10 Ханми Сайенс Ко., Лтд. Жидкие препаративные формы для длительно действующего конъюгата g-csf
KR101831300B1 (ko) 2010-10-29 2018-02-23 한미사이언스 주식회사 재조합 대장균으로부터 인간 과립구 콜로니 자극인자를 정제하는 방법

Also Published As

Publication number Publication date
JP2013517324A (ja) 2013-05-16
BR112012017979B1 (pt) 2021-10-13
EP2525787B1 (en) 2017-03-15
CA2787648C (en) 2014-10-07
RU2519031C1 (ru) 2014-06-10
KR20110085917A (ko) 2011-07-27
CN107412737A (zh) 2017-12-01
MX340463B (es) 2016-07-06
ES2654102T3 (es) 2018-02-12
HK1246190A1 (zh) 2018-09-07
AR080427A1 (es) 2012-04-11
CA2787648A1 (en) 2011-07-28
AU2011207915B2 (en) 2013-07-11
JP5657698B2 (ja) 2015-01-21
WO2011090305A2 (en) 2011-07-28
TWI409082B (zh) 2013-09-21
CN102740840A (zh) 2012-10-17
KR101340710B1 (ko) 2013-12-12
EP2525787A2 (en) 2012-11-28
BR112012017979A2 (pt) 2016-05-03
JP2014224151A (ja) 2014-12-04
US9867777B2 (en) 2018-01-16
EP2525787A4 (en) 2014-07-02
MX2012008454A (es) 2012-11-06
TW201129387A (en) 2011-09-01
US20120294829A1 (en) 2012-11-22
AU2011207915A1 (en) 2012-08-23
HUE034398T2 (en) 2018-02-28
WO2011090305A3 (en) 2011-11-10

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