JP7783051B2 - 抗ａｎｇｐｔｌ３抗体を含有する安定化製剤 - Google Patents

抗ａｎｇｐｔｌ３抗体を含有する安定化製剤

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Publication number
JP7783051B2
JP7783051B2 JP2021569354A JP2021569354A JP7783051B2 JP 7783051 B2 JP7783051 B2 JP 7783051B2 JP 2021569354 A JP2021569354 A JP 2021569354A JP 2021569354 A JP2021569354 A JP 2021569354A JP 7783051 B2 JP7783051 B2 JP 7783051B2
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Prior art keywords
antibody
pharmaceutical formulation
liquid pharmaceutical
formulation
concentration
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JP2021569354A
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Japanese (ja)
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JP2022532927A5 (https=
JP2022532927A (ja
Inventor
ディンヂィァン・リウ
アンドリア・スキナー
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Regeneron Pharmaceuticals Inc
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Regeneron Pharmaceuticals Inc
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    • 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
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61K9/0012—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
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays or needleless injectors
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • 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)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Endocrinology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
JP2021569354A 2019-05-24 2020-05-24 抗ａｎｇｐｔｌ３抗体を含有する安定化製剤 Active JP7783051B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962852643P 2019-05-24 2019-05-24
US62/852,643 2019-05-24
PCT/US2020/034438 WO2020243031A1 (en) 2019-05-24 2020-05-24 Stabilized formulations containing anti-angptl3 antibodies

Publications (3)

Publication Number Publication Date
JP2022532927A JP2022532927A (ja) 2022-07-20
JP2022532927A5 JP2022532927A5 (https=) 2023-05-09
JP7783051B2 true JP7783051B2 (ja) 2025-12-09

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JP2021569354A Active JP7783051B2 (ja) 2019-05-24 2020-05-24 抗ａｎｇｐｔｌ３抗体を含有する安定化製剤

Country Status (16)

Country Link
US (1) US12559551B2 (https=)
EP (1) EP3976647A1 (https=)
JP (1) JP7783051B2 (https=)
KR (1) KR20220011727A (https=)
AU (1) AU2020282956A1 (https=)
BR (1) BR112021023501A2 (https=)
CA (1) CA3139333A1 (https=)
CL (1) CL2021003026A1 (https=)
CO (1) CO2021016183A2 (https=)
EA (1) EA202193240A1 (https=)
IL (1) IL288153A (https=)
MA (1) MA56049A (https=)
MX (1) MX2021014332A (https=)
PH (1) PH12021552788A1 (https=)
SG (1) SG11202112256SA (https=)
WO (1) WO2020243031A1 (https=)

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AR087329A1 (es) * 2011-06-17 2014-03-19 Regeneron Pharma Anticuerpos humanos contra proteina 3 de tipo angiopoietina humana
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IL308643B2 (en) 2017-05-05 2025-02-01 Regeneron Pharma Auto-injector
JP2024509937A (ja) * 2021-03-09 2024-03-05 ジーアイ・イノベイション・インコーポレイテッド Ｉｇｅ ｆｃ受容体のアルファサブユニットの細胞外ドメインを含む融合タンパク質の製剤
EP4375298A4 (en) * 2021-07-21 2025-02-26 Jiangsu Hengrui Pharmaceuticals Co., Ltd. Pharmaceutical composition of anti-angptl3 antibody or antigen binding fragment thereof and its application
USD1007676S1 (en) 2021-11-16 2023-12-12 Regeneron Pharmaceuticals, Inc. Wearable autoinjector
EP4453210A1 (en) 2021-12-22 2024-10-30 Regeneron Pharmaceuticals, Inc. Treatment of kidney diseases with angiopoietin like 3 (angptl3) inhibitors
IL316249A (en) 2022-05-02 2024-12-01 Novo Nordisk As Novel anti-angptl3 antibodies suitable for high concentration compositions and subcutaneous administration
EP4615974A1 (en) 2022-11-10 2025-09-17 Regeneron Pharmaceuticals, Inc. Treatment of kidney diseases with a combination of angiopoietin like 3 (angptl3) inhibitors and solute carrier family 5 member 2 (slc5a2) inhibitors
WO2025075970A1 (en) 2023-10-02 2025-04-10 Regeneron Pharmaceuticals, Inc. Drug delivery device safety system

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JP2017222654A (ja) 2011-07-19 2017-12-21 中外製薬株式会社 アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤
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Publication number Publication date
CN114007647A (zh) 2022-02-01
WO2020243031A1 (en) 2020-12-03
EA202193240A1 (ru) 2022-03-14
CL2021003026A1 (es) 2022-06-24
KR20220011727A (ko) 2022-01-28
IL288153A (en) 2022-01-01
CO2021016183A2 (es) 2021-12-10
AU2020282956A1 (en) 2022-01-27
PH12021552788A1 (en) 2022-09-28
US20200369760A1 (en) 2020-11-26
EP3976647A1 (en) 2022-04-06
MA56049A (fr) 2022-04-06
BR112021023501A2 (pt) 2022-01-18
CA3139333A1 (en) 2020-12-03
SG11202112256SA (en) 2021-12-30
JP2022532927A (ja) 2022-07-20
MX2021014332A (es) 2022-04-06
US12559551B2 (en) 2026-02-24

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