JP2022547162A - 抗ＩＬ－２３ｐ１９抗体製剤 - Google Patents

抗ＩＬ－２３ｐ１９抗体製剤 Download PDF

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Publication number
JP2022547162A
JP2022547162A JP2022515471A JP2022515471A JP2022547162A JP 2022547162 A JP2022547162 A JP 2022547162A JP 2022515471 A JP2022515471 A JP 2022515471A JP 2022515471 A JP2022515471 A JP 2022515471A JP 2022547162 A JP2022547162 A JP 2022547162A
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JP
Japan
Prior art keywords
formulation
antibody
less
storage
formulations
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Pending
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JP2022515471A
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English (en)
Japanese (ja)
Inventor
ガリデル，パトリック
シュルツ－ファーデムレヒト，トルシュテン
Original Assignee
ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング
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Publication of JP2022547162A publication Critical patent/JP2022547162A/ja
Priority to JP2025127141A priority Critical patent/JP2025163108A/ja
Pending legal-status Critical Current

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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
    • 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
    • A61K47/08—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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • 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
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51—Complete heavy chain or Fd fragment, i.e. VH + CH1
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515—Complete light chain, i.e. VL + CL
    • 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

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  • 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)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Rheumatology (AREA)
  • Endocrinology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
JP2022515471A 2019-09-09 2020-09-09 抗ＩＬ－２３ｐ１９抗体製剤 Pending JP2022547162A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025127141A JP2025163108A (ja) 2019-09-09 2025-07-30 抗ＩＬ－２３ｐ１９抗体製剤

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962897930P 2019-09-09 2019-09-09
US62/897,930 2019-09-09
PCT/IB2020/058347 WO2021048743A1 (en) 2019-09-09 2020-09-09 Anti-il-23p19 antibody formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2025127141A Division JP2025163108A (ja) 2019-09-09 2025-07-30 抗ＩＬ－２３ｐ１９抗体製剤

Publications (1)

Publication Number Publication Date
JP2022547162A true JP2022547162A (ja) 2022-11-10

Family

ID=72615913

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2022515471A Pending JP2022547162A (ja) 2019-09-09 2020-09-09 抗ＩＬ－２３ｐ１９抗体製剤
JP2025127141A Pending JP2025163108A (ja) 2019-09-09 2025-07-30 抗ＩＬ－２３ｐ１９抗体製剤

Family Applications After (1)

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JP2025127141A Pending JP2025163108A (ja) 2019-09-09 2025-07-30 抗ＩＬ－２３ｐ１９抗体製剤

Country Status (14)

Country Link
US (1) US20210070852A1 (enExample)
EP (1) EP4028419A1 (enExample)
JP (2) JP2022547162A (enExample)
KR (1) KR20220062359A (enExample)
CN (1) CN114340674A (enExample)
AU (1) AU2020345071A1 (enExample)
BR (1) BR112022003169A2 (enExample)
CA (1) CA3147328A1 (enExample)
CL (1) CL2024002086A1 (enExample)
IL (1) IL291131A (enExample)
MX (1) MX2022002850A (enExample)
PH (1) PH12022550558A1 (enExample)
TW (2) TW202535466A (enExample)
WO (1) WO2021048743A1 (enExample)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL307578A (en) 2015-02-04 2023-12-01 Boehringer Ingelheim Int Methods of treating inflammatory diseases
AU2020409124A1 (en) 2019-12-20 2022-06-30 Novarock Biotherapeutics, Ltd. Anti-interleukin-23 p19 antibodies and methods of use thereof
WO2023019556A1 (zh) * 2021-08-20 2023-02-23 齐鲁制药有限公司 一种高浓度抗her2的抗体制剂及其用途
KR20250039516A (ko) * 2022-06-15 2025-03-20 애브비 인코포레이티드 리산키주맙 조성물
WO2024085697A1 (en) * 2022-10-21 2024-04-25 Chong Kun Dang Pharmaceutical Corp. Stable antibody composition
WO2025071362A1 (ko) * 2023-09-27 2025-04-03 삼성바이오에피스 주식회사 항-il-23 항체의 안정한 액상 제형
WO2025137347A1 (en) * 2023-12-20 2025-06-26 Abbvie Inc. High concentration risankizumab formulations

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000510813A (ja) * 1995-02-06 2000-08-22 ジェネテイックス・インスティテュート・インコーポレイテッド Ｉｌ−１２用処方
JP2005508981A (ja) * 2001-11-08 2005-04-07 プロテイン デザイン ラブス インコーポレイティド Ｉｇｇ抗体の安定な液体医薬製剤
JP2014500009A (ja) * 2010-11-04 2014-01-09 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング 抗ｉｌ−２３抗体

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3501537A1 (en) * 2005-06-30 2019-06-26 Janssen Biotech, Inc. Anti-il23 antibodies, compositions, methods and uses
WO2010027766A1 (en) * 2008-08-27 2010-03-11 Schering Corporation Lyophilized formulatons of engineered anti-il-23p19 antibodies
US9265834B2 (en) * 2009-03-05 2016-02-23 Ablynx N.V. Stable formulations of polypeptides and uses thereof
EP4039275A1 (en) * 2012-05-03 2022-08-10 Boehringer Ingelheim International GmbH Anti-il-23p19 antibodies
UA117466C2 (uk) * 2012-12-13 2018-08-10 Мерк Шарп Енд Доме Корп. СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19
IL307578A (en) * 2015-02-04 2023-12-01 Boehringer Ingelheim Int Methods of treating inflammatory diseases
GB201612317D0 (en) * 2016-07-15 2016-08-31 Philogen Spa Antibody compositions
EP3677597A1 (en) * 2016-10-14 2020-07-08 Boehringer Ingelheim International GmbH Methods of treating diseases
EP3810268A1 (en) * 2018-06-20 2021-04-28 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with an il-12/il-23 inhibitor

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000510813A (ja) * 1995-02-06 2000-08-22 ジェネテイックス・インスティテュート・インコーポレイテッド Ｉｌ−１２用処方
JP2005508981A (ja) * 2001-11-08 2005-04-07 プロテイン デザイン ラブス インコーポレイティド Ｉｇｇ抗体の安定な液体医薬製剤
JP2014500009A (ja) * 2010-11-04 2014-01-09 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング 抗ｉｌ−２３抗体

Also Published As

Publication number Publication date
KR20220062359A (ko) 2022-05-16
JP2025163108A (ja) 2025-10-28
CA3147328A1 (en) 2021-03-18
BR112022003169A2 (pt) 2022-05-17
TW202535466A (zh) 2025-09-16
MX2022002850A (es) 2022-04-06
US20210070852A1 (en) 2021-03-11
TW202123965A (zh) 2021-07-01
WO2021048743A1 (en) 2021-03-18
CN114340674A (zh) 2022-04-12
IL291131A (en) 2022-05-01
EP4028419A1 (en) 2022-07-20
CL2024002086A1 (es) 2025-01-10
AU2020345071A1 (en) 2022-03-24
PH12022550558A1 (en) 2023-02-20

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