JP7407723B2 - ヒト抗ｉｌ－３３モノクローナル抗体含有医薬用組成物 - Google Patents

ヒト抗ｉｌ－３３モノクローナル抗体含有医薬用組成物 Download PDF

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Publication number
JP7407723B2
JP7407723B2 JP2020546239A JP2020546239A JP7407723B2 JP 7407723 B2 JP7407723 B2 JP 7407723B2 JP 2020546239 A JP2020546239 A JP 2020546239A JP 2020546239 A JP2020546239 A JP 2020546239A JP 7407723 B2 JP7407723 B2 JP 7407723B2
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pharmaceutical composition
antibody
human anti
monoclonal antibody
sorbitol
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JPWO2020054871A1 (ja
Inventor
啓祐 池本
直樹 森
浩 斉藤
昌彦 谷本
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Mitsubishi Tanabe Pharma Corp
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Mitsubishi Tanabe Pharma Corp
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    • 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
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • 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
    • A61K47/16—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
    • A61K47/22—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
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • 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)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Pulmonology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Immunology (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
JP2020546239A 2018-09-14 2019-09-13 ヒト抗ｉｌ－３３モノクローナル抗体含有医薬用組成物 Active JP7407723B2 (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2023173122A JP7715778B2 (ja) 2018-09-14 2023-10-04 ヒト抗ｉｌ－３３モノクローナル抗体含有医薬用組成物
JP2025119629A JP2025148537A (ja) 2018-09-14 2025-07-16 ヒト抗ｉｌ－３３モノクローナル抗体含有医薬用組成物

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2018173103 2018-09-14
JP2018173103 2018-09-14
PCT/JP2019/036239 WO2020054871A1 (ja) 2018-09-14 2019-09-13 ヒト抗ｉｌ－３３モノクローナル抗体含有医薬用組成物

Related Child Applications (1)

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JP2023173122A Division JP7715778B2 (ja) 2018-09-14 2023-10-04 ヒト抗ｉｌ－３３モノクローナル抗体含有医薬用組成物

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JPWO2020054871A1 JPWO2020054871A1 (ja) 2021-08-30
JP7407723B2 true JP7407723B2 (ja) 2024-01-04

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JP2020546239A Active JP7407723B2 (ja) 2018-09-14 2019-09-13 ヒト抗ｉｌ－３３モノクローナル抗体含有医薬用組成物
JP2023173122A Active JP7715778B2 (ja) 2018-09-14 2023-10-04 ヒト抗ｉｌ－３３モノクローナル抗体含有医薬用組成物
JP2025119629A Pending JP2025148537A (ja) 2018-09-14 2025-07-16 ヒト抗ｉｌ－３３モノクローナル抗体含有医薬用組成物

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JP2023173122A Active JP7715778B2 (ja) 2018-09-14 2023-10-04 ヒト抗ｉｌ－３３モノクローナル抗体含有医薬用組成物
JP2025119629A Pending JP2025148537A (ja) 2018-09-14 2025-07-16 ヒト抗ｉｌ－３３モノクローナル抗体含有医薬用組成物

Country Status (5)

Country Link
US (1) US20220041709A1 (enExample)
EP (1) EP3851121A4 (enExample)
JP (3) JP7407723B2 (enExample)
CN (3) CN112739378B (enExample)
WO (1) WO2020054871A1 (enExample)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3190793A1 (en) 2013-12-26 2015-07-02 Mitsubishi Tanabe Pharma Corporation Human anti-il-33 neutralizing monoclonal antibody
CN115920031A (zh) 2017-08-31 2023-04-07 田边三菱制药株式会社 含有il-33拮抗剂的子宫内膜异位症治疗剂
US20230174638A1 (en) * 2020-05-11 2023-06-08 Medimmune Limited Formulations of anti-il-33 antibodies
CN113603775B (zh) 2021-09-03 2022-05-20 江苏荃信生物医药股份有限公司 抗人白介素-33单克隆抗体及其应用
CN113842457B (zh) * 2021-11-04 2022-05-20 江苏荃信生物医药股份有限公司 包含抗人白介素-33单克隆抗体的液体制剂

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015099175A1 (ja) 2013-12-26 2015-07-02 田辺三菱製薬株式会社 ヒト抗ｉｌ－３３中和モノクローナル抗体
JP2017008003A (ja) 2015-06-25 2017-01-12 田辺三菱製薬株式会社 ヒト抗ｉｌ−３３中和モノクローナル抗体

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US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
US5869046A (en) * 1995-04-14 1999-02-09 Genentech, Inc. Altered polypeptides with increased half-life
US6171586B1 (en) * 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
WO2002079415A2 (en) * 2001-03-30 2002-10-10 Lexigen Pharmaceuticals Corp. Reducing the immunogenicity of fusion proteins
MX344727B (es) * 2010-11-11 2017-01-05 Abbvie Biotechnology Ltd Formulaciones liquidas de anticuerpos anti-tnf-alfa de alta concentracion mejoradas.
WO2016031932A1 (ja) * 2014-08-27 2016-03-03 田辺三菱製薬株式会社 アルカリ洗浄によるＦｃ領域を有するタンパク質の製造方法
NZ736026A (en) * 2015-03-31 2023-02-24 Medimmune Ltd A novel il33 form, mutated forms of il33, antibodies, assays and methods of using the same
US20190046642A1 (en) * 2016-02-23 2019-02-14 Eleven Biotherapeutics, Inc. Il-6 antagonist formulations and uses thereof
EP3589318A1 (en) * 2017-03-01 2020-01-08 MedImmune Limited Formulations of monoclonal antibodies
CN115920031A (zh) * 2017-08-31 2023-04-07 田边三菱制药株式会社 含有il-33拮抗剂的子宫内膜异位症治疗剂

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015099175A1 (ja) 2013-12-26 2015-07-02 田辺三菱製薬株式会社 ヒト抗ｉｌ－３３中和モノクローナル抗体
JP2017008003A (ja) 2015-06-25 2017-01-12 田辺三菱製薬株式会社 ヒト抗ｉｌ−３３中和モノクローナル抗体

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伊豆津 健一，タンパク質医薬品の凍結乾燥，薬剤学，2012年，第72巻, 第6号，p.353-358，ISSN 0372-7629
内山 進，バイオ医薬品の分析のコツ 品質評価のための基礎と応用 第6回 タンパク質溶液の性質，PHARM TECH JAPAN，2018年01月，第34巻, 第1号，p.109-120，ISSN 0910-4739
本田 真也 ほか，バイオ医薬品の分析のコツ 品質評価のための基礎と応用 第9回 タンパク質の安定性分析と安定化設計(後編)，PHARM TECH JAPAN，2018年04月，第34巻, 第5号，p.885-894，ISSN 0910-4739

Also Published As

Publication number Publication date
JP2025148537A (ja) 2025-10-07
EP3851121A4 (en) 2022-06-08
JPWO2020054871A1 (ja) 2021-08-30
WO2020054871A1 (ja) 2020-03-19
CN120267817A (zh) 2025-07-08
CN120267816A (zh) 2025-07-08
EP3851121A1 (en) 2021-07-21
CN112739378B (zh) 2025-05-06
JP2023182736A (ja) 2023-12-26
US20220041709A1 (en) 2022-02-10
JP7715778B2 (ja) 2025-07-30
CN112739378A (zh) 2021-04-30

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