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DK3247394T3 - Farmaceutisk formulering omfattende anti-egfr-antistof - Google Patents

Farmaceutisk formulering omfattende anti-egfr-antistof Download PDF

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Publication number
DK3247394T3
DK3247394T3 DK16740356.7T DK16740356T DK3247394T3 DK 3247394 T3 DK3247394 T3 DK 3247394T3 DK 16740356 T DK16740356 T DK 16740356T DK 3247394 T3 DK3247394 T3 DK 3247394T3
Authority
DK
Denmark
Prior art keywords
pharmaceutical formulation
egfr antibody
including anti
formulation including
egfr
Prior art date
Application number
DK16740356.7T
Other languages
English (en)
Inventor
Yong Woon Choi
Yoo Hoon Kim
Jungsub Choi
Original Assignee
Green Cross Corp
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 Green Cross Corp filed Critical Green Cross Corp
Application granted granted Critical
Publication of DK3247394T3 publication Critical patent/DK3247394T3/da

Links

Classifications

    • 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
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • 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
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oncology (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Inorganic Chemistry (AREA)
DK16740356.7T 2015-01-19 2016-01-15 Farmaceutisk formulering omfattende anti-egfr-antistof DK3247394T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020150008677A KR101776879B1 (ko) 2015-01-19 2015-01-19 항-egfr 항체를 포함하는 약학 제제
PCT/KR2016/000472 WO2016117883A2 (en) 2015-01-19 2016-01-15 Pharmaceutical formulation comprising anti-egfr antibody

Publications (1)

Publication Number Publication Date
DK3247394T3 true DK3247394T3 (da) 2021-06-07

Family

ID=56417907

Family Applications (1)

Application Number Title Priority Date Filing Date
DK16740356.7T DK3247394T3 (da) 2015-01-19 2016-01-15 Farmaceutisk formulering omfattende anti-egfr-antistof

Country Status (13)

Country Link
US (1) US10918717B2 (da)
EP (1) EP3247394B1 (da)
JP (1) JP6545806B2 (da)
KR (1) KR101776879B1 (da)
CN (1) CN107249634B (da)
DK (1) DK3247394T3 (da)
ES (1) ES2874593T3 (da)
HR (1) HRP20210890T1 (da)
HU (1) HUE054716T2 (da)
PL (1) PL3247394T3 (da)
PT (1) PT3247394T (da)
SI (1) SI3247394T1 (da)
WO (1) WO2016117883A2 (da)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102208378B1 (ko) * 2017-08-17 2021-01-28 주식회사 녹십자 항-egfr 항체를 포함하는 약학 제제
CN111665352B (zh) * 2020-06-23 2024-05-17 广州市丹蓝生物科技有限公司 一种储存剂及由其制备的抗体溶液制剂及其应用
JPWO2024058201A1 (da) * 2022-09-16 2024-03-21
WO2025113442A1 (zh) * 2023-11-29 2025-06-05 四川科伦博泰生物医药股份有限公司 抗体制剂

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR930010489B1 (ko) 1991-06-05 1993-10-25 김경환 온상용 하우스의 지지골조
WO1996040210A1 (en) 1995-06-07 1996-12-19 Imclone Systems Incorporated Antibody and antibody fragments for inhibiting the growth of tumors
US6171586B1 (en) 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
JP4317010B2 (ja) 2001-07-25 2009-08-19 ピーディーエル バイオファーマ，インコーポレイティド ＩｇＧ抗体の安定な凍結乾燥医薬製剤
DE10355251A1 (de) 2003-11-26 2005-06-23 Merck Patent Gmbh Pharmazeutische Zubereitung enthaltend einen Antikörper gegen den EGF-Rezeptor
KR20080014745A (ko) * 2005-04-01 2008-02-14 암젠 인코포레이티드 상피세포 성장인자 수용체 유전자 복제 수
KR20090021298A (ko) * 2006-06-14 2009-03-02 임클론 시스템즈 인코포레이티드 항-ｅｇｆｒ 항체의 동결건조 제제
TW200831129A (en) * 2006-10-06 2008-08-01 Amgen Inc Stable formulations
EP2684895A1 (en) * 2006-10-27 2014-01-15 AbbVie Biotechnology Ltd Crystalline anti-hTNFalpha antibodies
KR101108642B1 (ko) * 2009-09-29 2012-02-09 주식회사 녹십자 표피 성장 인자 수용체에 특이적으로 결합하는 항체
JP5896471B2 (ja) 2009-11-20 2016-03-30 バイオコン リミテッドＢｉｏｃｏｎ Ｌｉｍｉｔｅｄ 抗体製剤
CA2783715A1 (en) 2009-12-29 2011-07-07 F. Hoffmann-La Roche Ag Novel antibody formulation
EP2542221A4 (en) 2010-03-01 2013-10-23 Cytodyn Inc CONCENTRATED PROTEIN FORMULATIONS AND USES THEREOF
AU2012239997A1 (en) * 2011-04-07 2013-10-17 Amgen Inc. Novel EGFR binding proteins
CN104394879A (zh) * 2012-03-27 2015-03-04 株式会社绿十字 表皮生长因子受体表面抗原的表位及其用途
MX367748B (es) * 2012-12-21 2019-09-04 Glenmark Pharmaceuticals Sa Formulación de anticuerpo anti her2.
TWI679019B (zh) * 2013-04-29 2019-12-11 法商賽諾菲公司 抗ｉｌ－４／抗ｉｌ－１３之雙特異性抗體調配物
KR20160055253A (ko) * 2013-09-12 2016-05-17 할로자임, 아이엔씨 변형된 항-상피세포 성장인자 수용체 항체 및 이의 사용 방법

Also Published As

Publication number Publication date
HRP20210890T1 (hr) 2021-07-23
EP3247394B1 (en) 2021-05-12
KR20160089136A (ko) 2016-07-27
WO2016117883A3 (en) 2016-09-01
JP6545806B2 (ja) 2019-07-17
CN107249634A (zh) 2017-10-13
PT3247394T (pt) 2021-06-14
US10918717B2 (en) 2021-02-16
US20170368175A1 (en) 2017-12-28
JP2018502139A (ja) 2018-01-25
WO2016117883A2 (en) 2016-07-28
PL3247394T3 (pl) 2021-08-30
WO2016117883A8 (en) 2017-07-20
ES2874593T3 (es) 2021-11-05
EP3247394A4 (en) 2018-06-06
SI3247394T1 (sl) 2021-08-31
HUE054716T2 (hu) 2021-09-28
KR101776879B1 (ko) 2017-09-08
EP3247394A2 (en) 2017-11-29
CN107249634B (zh) 2021-11-16

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