JP7695887B2 - 抗il-33抗体を含有する安定化製剤 - Google Patents

抗il-33抗体を含有する安定化製剤 Download PDF

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Publication number
JP7695887B2
JP7695887B2 JP2021556435A JP2021556435A JP7695887B2 JP 7695887 B2 JP7695887 B2 JP 7695887B2 JP 2021556435 A JP2021556435 A JP 2021556435A JP 2021556435 A JP2021556435 A JP 2021556435A JP 7695887 B2 JP7695887 B2 JP 7695887B2
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pharmaceutical formulation
antibody
liquid pharmaceutical
stable liquid
formulation
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Japanese (ja)
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JP2022526292A5 (https=
JPWO2020191270A5 (https=
JP2022526292A (ja
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チンヤン・フー
ディンヂィァン・リウ
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Regeneron Pharmaceuticals Inc
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Regeneron Pharmaceuticals Inc
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    • 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
    • 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
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/16Organic 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
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244Interleukins [IL]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Environmental & Geological Engineering (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
JP2021556435A 2019-03-21 2020-03-20 抗il-33抗体を含有する安定化製剤 Active JP7695887B2 (ja)

Priority Applications (1)

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JP2025094518A JP2025131756A (ja) 2019-03-21 2025-06-06 抗il-33抗体を含有する安定化製剤

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962821661P 2019-03-21 2019-03-21
US62/821,661 2019-03-21
PCT/US2020/023795 WO2020191270A1 (en) 2019-03-21 2020-03-20 Stabilized formulations containing anti-il-33 antibodies

Related Child Applications (1)

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JP2025094518A Division JP2025131756A (ja) 2019-03-21 2025-06-06 抗il-33抗体を含有する安定化製剤

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JP2022526292A JP2022526292A (ja) 2022-05-24
JP2022526292A5 JP2022526292A5 (https=) 2023-03-24
JPWO2020191270A5 JPWO2020191270A5 (https=) 2023-03-24
JP7695887B2 true JP7695887B2 (ja) 2025-06-19

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JP2021556435A Active JP7695887B2 (ja) 2019-03-21 2020-03-20 抗il-33抗体を含有する安定化製剤
JP2025094518A Pending JP2025131756A (ja) 2019-03-21 2025-06-06 抗il-33抗体を含有する安定化製剤

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US (2) US11596690B2 (https=)
EP (1) EP3941522A1 (https=)
JP (2) JP7695887B2 (https=)
KR (1) KR20210141592A (https=)
CN (3) CN119700966A (https=)
AU (1) AU2020241882A1 (https=)
BR (1) BR112021018727A2 (https=)
CA (1) CA3133995A1 (https=)
CL (1) CL2021002440A1 (https=)
CO (1) CO2021011648A2 (https=)
EA (1) EA202192568A1 (https=)
IL (2) IL286024B2 (https=)
MA (1) MA55362A (https=)
MX (1) MX2021011137A (https=)
PH (1) PH12021552092A1 (https=)
SA (1) SA521430229B1 (https=)
SG (1) SG11202109822XA (https=)
TW (2) TW202519263A (https=)
WO (1) WO2020191270A1 (https=)

Families Citing this family (6)

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KR102735988B1 (ko) 2019-02-18 2024-12-03 일라이 릴리 앤드 캄파니 치료 항체 제제
KR20230010239A (ko) * 2020-05-11 2023-01-18 메디뮨 리미티드 항-il-33 항체의 제형물
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
WO2023077685A1 (zh) * 2021-11-04 2023-05-11 江苏荃信生物医药股份有限公司 包含抗人白介素-33单克隆抗体的浓缩溶液的制备方法及液体制剂
WO2026067832A1 (zh) * 2024-09-30 2026-04-02 深圳市小分子新药创新中心有限公司 抗il-33单域抗体及其衍生物

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JP2013543505A (ja) 2010-10-06 2013-12-05 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 抗インターロイキン−4受容体(il−4r)抗体を含有する安定化製剤
JP2015528465A (ja) 2012-08-31 2015-09-28 バイエル・ヘルスケア・エルエルシーBayer HealthCareLLC 抗プロラクチン受容体抗体製剤
WO2018102597A1 (en) 2016-12-01 2018-06-07 Regeneron Pharmaceuticals, Inc. Methods of treating inflammatory conditions
WO2018169348A1 (ko) 2017-03-16 2018-09-20 주식회사 엘지화학 항-tnf 알파 항체의 액상 제제

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JP2015528465A (ja) 2012-08-31 2015-09-28 バイエル・ヘルスケア・エルエルシーBayer HealthCareLLC 抗プロラクチン受容体抗体製剤
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Publication number Publication date
AU2020241882A1 (en) 2021-10-14
TWI861073B (zh) 2024-11-11
IL286024B1 (en) 2025-01-01
IL286024B2 (en) 2025-05-01
MX2021011137A (es) 2021-10-22
WO2020191270A1 (en) 2020-09-24
CN113573733B (zh) 2024-12-31
SG11202109822XA (en) 2021-10-28
US20200297845A1 (en) 2020-09-24
TW202519263A (zh) 2025-05-16
EA202192568A1 (ru) 2021-12-03
IL317899A (en) 2025-02-01
US20230346929A1 (en) 2023-11-02
PH12021552092A1 (en) 2022-05-30
CN113573733A (zh) 2021-10-29
EP3941522A1 (en) 2022-01-26
KR20210141592A (ko) 2021-11-23
CL2021002440A1 (es) 2022-04-22
IL286024A (en) 2021-10-31
US11596690B2 (en) 2023-03-07
MA55362A (fr) 2022-01-26
CN119700965A (zh) 2025-03-28
CO2021011648A2 (es) 2021-09-30
JP2022526292A (ja) 2022-05-24
CN119700966A (zh) 2025-03-28
BR112021018727A2 (pt) 2022-02-15
SA521430229B1 (ar) 2024-01-23
CA3133995A1 (en) 2020-09-24
JP2025131756A (ja) 2025-09-09
TW202102260A (zh) 2021-01-16

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