CN114340674A - 抗-IL-23p19抗体制剂 - Google Patents

抗-IL-23p19抗体制剂 Download PDF

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Publication number
CN114340674A
CN114340674A CN202080062754.3A CN202080062754A CN114340674A CN 114340674 A CN114340674 A CN 114340674A CN 202080062754 A CN202080062754 A CN 202080062754A CN 114340674 A CN114340674 A CN 114340674A
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China
Prior art keywords
formulation
antibody
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storage
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Pending
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CN202080062754.3A
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English (en)
Chinese (zh)
Inventor
P·加里德尔
T·许尔茨-法德姆雷希特
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boehringer Ingelheim International GmbH
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Boehringer Ingelheim International GmbH
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Publication of CN114340674A publication Critical patent/CN114340674A/zh
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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
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • 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]
    • 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
    • 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)
CN202080062754.3A 2019-09-09 2020-09-09 抗-IL-23p19抗体制剂 Pending CN114340674A (zh)

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

Publications (1)

Publication Number Publication Date
CN114340674A true CN114340674A (zh) 2022-04-12

Family

ID=72615913

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202080062754.3A Pending CN114340674A (zh) 2019-09-09 2020-09-09 抗-IL-23p19抗体制剂

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 (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101252951A (zh) * 2005-06-30 2008-08-27 森托科尔公司 抗il-23抗体、组合物、方法和用途
CN102202655A (zh) * 2008-08-27 2011-09-28 先灵公司 基因工程抗IL-23p19抗体的冻干制剂
CN104507497A (zh) * 2012-05-03 2015-04-08 勃林格殷格翰国际有限公司 抗IL-23p19抗体
CN104870016A (zh) * 2012-12-13 2015-08-26 默沙东有限公司 工程化的抗IL-23p19抗体的溶液制剂
CN107206081A (zh) * 2015-02-04 2017-09-26 勃林格殷格翰国际有限公司 治疗炎性疾病的方法

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU695129B2 (en) * 1995-02-06 1998-08-06 Genetics Institute, Llc Formulations for IL-12
EP1441589B1 (en) * 2001-11-08 2012-05-09 Abbott Biotherapeutics Corp. Stable liquid pharmaceutical formulation of igg antibodies
US9265834B2 (en) * 2009-03-05 2016-02-23 Ablynx N.V. Stable formulations of polypeptides and uses thereof
PT2635601T (pt) * 2010-11-04 2016-09-27 Boehringer Ingelheim Int Anticorpos anti-il-23
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 (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101252951A (zh) * 2005-06-30 2008-08-27 森托科尔公司 抗il-23抗体、组合物、方法和用途
CN102202655A (zh) * 2008-08-27 2011-09-28 先灵公司 基因工程抗IL-23p19抗体的冻干制剂
CN104507497A (zh) * 2012-05-03 2015-04-08 勃林格殷格翰国际有限公司 抗IL-23p19抗体
CN104870016A (zh) * 2012-12-13 2015-08-26 默沙东有限公司 工程化的抗IL-23p19抗体的溶液制剂
CN107206081A (zh) * 2015-02-04 2017-09-26 勃林格殷格翰国际有限公司 治疗炎性疾病的方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
HAUGH IM等: "Risankizumab: an anti-IL-23 antibody for the treatment of psoriasis", 《DRUG DES DEVEL THER》, 12 November 2018 (2018-11-12), pages 3879 - 3883 *

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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
JP2022547162A (ja) 2022-11-10
TW202123965A (zh) 2021-07-01
WO2021048743A1 (en) 2021-03-18
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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