CN112739378B - 含有人抗il-33单克隆抗体的医药用组合物 - Google Patents

含有人抗il-33单克隆抗体的医药用组合物 Download PDF

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Publication number
CN112739378B
CN112739378B CN201980060117.XA CN201980060117A CN112739378B CN 112739378 B CN112739378 B CN 112739378B CN 201980060117 A CN201980060117 A CN 201980060117A CN 112739378 B CN112739378 B CN 112739378B
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China
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pharmaceutical composition
polysorbate
antibody
human anti
sorbitol
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CN201980060117.XA
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Chinese (zh)
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CN112739378A (zh
Inventor
池本启祐
森直树
齐藤浩
谷本昌彦
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Mitsubishi Tanabe Pharma Corp
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Mitsubishi Tanabe Pharma Corp
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Priority to CN202510483754.5A priority Critical patent/CN120267817A/zh
Priority to CN202510482161.7A priority patent/CN120267816A/zh
Publication of CN112739378A publication Critical patent/CN112739378A/zh
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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)
CN201980060117.XA 2018-09-14 2019-09-13 含有人抗il-33单克隆抗体的医药用组合物 Active CN112739378B (zh)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN202510483754.5A CN120267817A (zh) 2018-09-14 2019-09-13 含有人抗il-33单克隆抗体的医药用组合物
CN202510482161.7A CN120267816A (zh) 2018-09-14 2019-09-13 含有人抗il-33单克隆抗体的医药用组合物

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2018-173103 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 (2)

Application Number Title Priority Date Filing Date
CN202510483754.5A Division CN120267817A (zh) 2018-09-14 2019-09-13 含有人抗il-33单克隆抗体的医药用组合物
CN202510482161.7A Division CN120267816A (zh) 2018-09-14 2019-09-13 含有人抗il-33单克隆抗体的医药用组合物

Publications (2)

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CN112739378A CN112739378A (zh) 2021-04-30
CN112739378B true CN112739378B (zh) 2025-05-06

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CN201980060117.XA Active CN112739378B (zh) 2018-09-14 2019-09-13 含有人抗il-33单克隆抗体的医药用组合物
CN202510483754.5A Pending CN120267817A (zh) 2018-09-14 2019-09-13 含有人抗il-33单克隆抗体的医药用组合物
CN202510482161.7A Pending CN120267816A (zh) 2018-09-14 2019-09-13 含有人抗il-33单克隆抗体的医药用组合物

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CN202510483754.5A Pending CN120267817A (zh) 2018-09-14 2019-09-13 含有人抗il-33单克隆抗体的医药用组合物
CN202510482161.7A Pending CN120267816A (zh) 2018-09-14 2019-09-13 含有人抗il-33单克隆抗体的医药用组合物

Country Status (5)

Country Link
US (1) US20220041709A1 (cg-RX-API-DMAC7.html)
EP (1) EP3851121A4 (cg-RX-API-DMAC7.html)
JP (3) JP7407723B2 (cg-RX-API-DMAC7.html)
CN (3) CN112739378B (cg-RX-API-DMAC7.html)
WO (1) WO2020054871A1 (cg-RX-API-DMAC7.html)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102400060B1 (ko) 2013-12-26 2022-05-19 미쓰비시 타나베 파마 코퍼레이션 인간 항 il-33 중화 단일클론 항체
CN115920041A (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
IL297841A (en) * 2020-05-11 2023-01-01 Medimmune Ltd 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 (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018158332A1 (en) * 2017-03-01 2018-09-07 Medimmune Limited Formulations of monoclonal antibodies

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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
US6992174B2 (en) * 2001-03-30 2006-01-31 Emd Lexigen Research Center Corp. Reducing the immunogenicity of fusion proteins
TWI606840B (zh) * 2010-11-11 2017-12-01 艾伯維生物技術有限責任公司 具有增進高濃度之抗-ＴＮＦα抗體之液體調配物
KR102400060B1 (ko) * 2013-12-26 2022-05-19 미쓰비시 타나베 파마 코퍼레이션 인간 항 il-33 중화 단일클론 항체
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
JP6862351B2 (ja) * 2015-03-31 2021-04-21 メドイミューン・リミテッドＭｅｄＩｍｍｕｎｅ Ｌｉｍｉｔｅｄ 新規ｉｌ３３型、変異型のｉｌ３３、抗体、アッセイ及びそれらの使用方法
JP6501650B2 (ja) * 2015-06-25 2019-04-17 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
KR20180116359A (ko) * 2016-02-23 2018-10-24 세센 바이오, 아이엔씨. 인터루킨-6의 길항제 제제 및 이의 용도
CN115920041A (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 (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018158332A1 (en) * 2017-03-01 2018-09-07 Medimmune Limited Formulations of monoclonal antibodies

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Publication number Publication date
US20220041709A1 (en) 2022-02-10
WO2020054871A1 (ja) 2020-03-19
JPWO2020054871A1 (ja) 2021-08-30
EP3851121A1 (en) 2021-07-21
JP2023182736A (ja) 2023-12-26
CN120267817A (zh) 2025-07-08
JP2025148537A (ja) 2025-10-07
EP3851121A4 (en) 2022-06-08
CN120267816A (zh) 2025-07-08
JP7407723B2 (ja) 2024-01-04
JP7715778B2 (ja) 2025-07-30
CN112739378A (zh) 2021-04-30

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