CN110621303A - 抗TNFα抗体的液体制剂 - Google Patents

抗TNFα抗体的液体制剂 Download PDF

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Publication number
CN110621303A
CN110621303A CN201880031705.6A CN201880031705A CN110621303A CN 110621303 A CN110621303 A CN 110621303A CN 201880031705 A CN201880031705 A CN 201880031705A CN 110621303 A CN110621303 A CN 110621303A
Authority
CN
China
Prior art keywords
formulation
liquid formulation
adalimumab
concentration
arginine
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.)
Pending
Application number
CN201880031705.6A
Other languages
English (en)
Chinese (zh)
Inventor
尹素罗
高衍庆
苏震彦
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.)
LG Chem Ltd
LG Corp
Original Assignee
LG Chem 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=63522490&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CN110621303(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by LG Chem Ltd filed Critical LG Chem Ltd
Publication of CN110621303A publication Critical patent/CN110621303A/zh
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/46Cellular immunotherapy
    • A61K39/464Cellular immunotherapy characterised by the antigen targeted or presented
    • A61K39/4643Vertebrate antigens
    • A61K39/4644Cancer antigens
    • A61K39/464436Cytokines
    • A61K39/464438Tumor necrosis factors [TNF], CD70
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00Preparations for use in therapy

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Microbiology (AREA)
  • Immunology (AREA)
  • Mycology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oncology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Cell Biology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Endocrinology (AREA)
  • Biomedical Technology (AREA)
  • Peptides Or Proteins (AREA)
CN201880031705.6A 2017-03-16 2018-03-16 抗TNFα抗体的液体制剂 Pending CN110621303A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR20170033188 2017-03-16
KR10-2017-0033188 2017-03-16
PCT/KR2018/003097 WO2018169348A1 (ko) 2017-03-16 2018-03-16 항-tnf 알파 항체의 액상 제제

Publications (1)

Publication Number Publication Date
CN110621303A true CN110621303A (zh) 2019-12-27

Family

ID=63522490

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201880031705.6A Pending CN110621303A (zh) 2017-03-16 2018-03-16 抗TNFα抗体的液体制剂

Country Status (15)

Country Link
JP (2) JP7109849B2 (uk)
KR (2) KR20180106974A (uk)
CN (1) CN110621303A (uk)
AU (1) AU2018236651B2 (uk)
BR (1) BR112019019162A2 (uk)
CO (1) CO2019010860A2 (uk)
MA (1) MA46988A1 (uk)
MX (1) MX2019010895A (uk)
MY (1) MY197202A (uk)
NZ (1) NZ757965A (uk)
PH (1) PH12019502075A1 (uk)
RU (1) RU2756619C2 (uk)
UA (1) UA123847C2 (uk)
WO (1) WO2018169348A1 (uk)
ZA (1) ZA201906696B (uk)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021164717A1 (zh) * 2020-02-20 2021-08-26 百奥泰生物制药股份有限公司 抗TNF-α的抗体制剂及其制备方法和用途

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR112021015034A2 (pt) * 2019-02-18 2021-10-05 Eli Lilly And Company Formulação de anticorpo terapêutico
TW202102260A (zh) * 2019-03-21 2021-01-16 美商再生元醫藥公司 含有抗il-33抗體之穩定調配物

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104159614A (zh) * 2012-03-07 2014-11-19 卡迪拉保健有限公司 TNF-α抗体的药物制剂
CN104623656A (zh) * 2011-06-03 2015-05-20 株式会社Lg生命科学 依那西普的稳定液体制剂
WO2015151115A1 (en) * 2014-04-02 2015-10-08 Intas Pharmaceuticals Limited Liquid pharmaceutical composition of adalimumab
CN105051064A (zh) * 2013-01-24 2015-11-11 葛兰素史克知识产权开发有限公司 抗TNF-α抗原结合蛋白

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2815689C (en) * 2010-11-11 2016-11-22 Abbvie Biotechnology Ltd. Improved high concentration anti-tnf.alpha. antibody liquid formulations
BR112015004984A2 (pt) 2012-09-07 2017-07-04 Coherus Biosciences Inc formulações aquosas estáveis de adalimumab
CN105025925A (zh) 2013-03-15 2015-11-04 拜尔健康护理有限责任公司 抗-催乳素受体抗体制剂
WO2015134406A1 (en) 2014-03-03 2015-09-11 La Jolla Biologics, Inc. Stable aqueous recombinant protein formulations
LT2946765T (lt) * 2014-05-23 2016-11-25 Ares Trading S.A. Skysta farmacinė kompozicija
US9821059B2 (en) 2014-10-17 2017-11-21 Alteogen Inc. Composition for stabilizing protein and pharmaceutical formulation comprising the same
HUP1400510A1 (hu) * 2014-10-28 2016-05-30 Richter Gedeon Nyrt Gyógyászati TNFalfa ellenes antitest készítmény
WO2016120413A1 (en) * 2015-01-28 2016-08-04 Mabxience S.A. Pharmaceutical formulations for anti-tnf-alpha antibodies
WO2016162819A1 (en) * 2015-04-07 2016-10-13 Lupin Limited Stable aqueous pharmaceutical composition of anti-tnf alpha antibody

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104623656A (zh) * 2011-06-03 2015-05-20 株式会社Lg生命科学 依那西普的稳定液体制剂
CN104159614A (zh) * 2012-03-07 2014-11-19 卡迪拉保健有限公司 TNF-α抗体的药物制剂
CN105051064A (zh) * 2013-01-24 2015-11-11 葛兰素史克知识产权开发有限公司 抗TNF-α抗原结合蛋白
WO2015151115A1 (en) * 2014-04-02 2015-10-08 Intas Pharmaceuticals Limited Liquid pharmaceutical composition of adalimumab

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021164717A1 (zh) * 2020-02-20 2021-08-26 百奥泰生物制药股份有限公司 抗TNF-α的抗体制剂及其制备方法和用途

Also Published As

Publication number Publication date
AU2018236651A1 (en) 2019-10-31
MY197202A (en) 2023-05-31
AU2018236651B2 (en) 2020-12-10
ZA201906696B (en) 2020-08-26
BR112019019162A2 (pt) 2020-04-14
KR20180106974A (ko) 2018-10-01
MA46988A1 (fr) 2020-06-30
RU2019130728A3 (uk) 2021-04-16
JP2022097600A (ja) 2022-06-30
MX2019010895A (es) 2019-11-05
CO2019010860A2 (es) 2020-01-17
KR20200096472A (ko) 2020-08-12
UA123847C2 (uk) 2021-06-09
RU2756619C2 (ru) 2021-10-04
WO2018169348A1 (ko) 2018-09-20
PH12019502075A1 (en) 2020-09-14
NZ757965A (en) 2022-07-01
KR102342292B1 (ko) 2021-12-24
JP7109849B2 (ja) 2022-08-01
JP2020510079A (ja) 2020-04-02
RU2019130728A (ru) 2021-04-16

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