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CN115605231A - 包含抗IL-23p19抗体的制剂、其制备方法和用途 - Google Patents

包含抗IL-23p19抗体的制剂、其制备方法和用途 Download PDF

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Publication number
CN115605231A
CN115605231A CN202180034497.7A CN202180034497A CN115605231A CN 115605231 A CN115605231 A CN 115605231A CN 202180034497 A CN202180034497 A CN 202180034497A CN 115605231 A CN115605231 A CN 115605231A
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CN
China
Prior art keywords
antibody
liquid
formulation
histidine
antibody formulation
Prior art date
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Pending
Application number
CN202180034497.7A
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English (en)
Inventor
曹魏
马丽强
汪音爵
周凯松
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.)
Xinda Biomedical Technology (Hangzhou) Co.,Ltd.
Original Assignee
Innovent Biologics Suzhou Co Ltd
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Publication date
Application filed by Innovent Biologics Suzhou Co Ltd filed Critical Innovent Biologics Suzhou Co Ltd
Publication of CN115605231A publication Critical patent/CN115605231A/zh
Pending legal-status Critical Current

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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
    • 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
    • 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
    • A61K47/16—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
    • A61K9/08—Solutions
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • 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
    • 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

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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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

一种包含抗IL‑23P19抗体、缓冲剂、稳定剂和表面活性剂的药物制剂，以及这些制剂的疾病治疗或预防用途。

Description

PCT国内申请，说明书已公开。

Claims (16)

  1. PCT国内申请，权利要求书已公开。
CN202180034497.7A 2020-05-13 2021-05-12 包含抗IL-23p19抗体的制剂、其制备方法和用途 Pending CN115605231A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN202010404834 2020-05-13
CN2020104048344 2020-05-13
PCT/CN2021/093219 WO2021228113A1 (zh) 2020-05-13 2021-05-12 包含抗IL-23p19抗体的制剂、其制备方法和用途

Publications (1)

Publication Number Publication Date
CN115605231A true CN115605231A (zh) 2023-01-13

Family

ID=78525246

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202180034497.7A Pending CN115605231A (zh) 2020-05-13 2021-05-12 包含抗IL-23p19抗体的制剂、其制备方法和用途

Country Status (10)

Country Link
US (1) US20230173069A1 (zh)
EP (1) EP4151233A4 (zh)
JP (1) JP2023525825A (zh)
KR (1) KR20230009897A (zh)
CN (1) CN115605231A (zh)
AU (1) AU2021272212A1 (zh)
BR (1) BR112022022919A2 (zh)
CA (1) CA3178853A1 (zh)
TW (1) TWI802882B (zh)
WO (1) WO2021228113A1 (zh)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024255867A1 (zh) * 2023-06-16 2024-12-19 信达生物制药(苏州)有限公司 重组抗白介素23p19亚基抗体在治疗炎症性肠病中的用途

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024222891A1 (zh) * 2023-04-26 2024-10-31 信达生物制药(苏州)有限公司 用重组白介素23p19抗体治疗银屑病的方法
WO2024263900A2 (en) * 2023-06-22 2024-12-26 Paragon Therapeutics, Inc. Il-23 antibody compositions and methods of use

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6171586B1 (en) * 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
US20040033228A1 (en) * 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
JO3000B1 (ar) * 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
CN101252951B (zh) * 2005-06-30 2011-12-21 森托科尔公司 抗il-23抗体、组合物、方法和用途
ES2517420T3 (es) * 2005-12-29 2014-11-03 Janssen Biotech, Inc. Anticuerpos anti-IL-23 humanos, composiciones, procedimientos y usos
US20100111966A1 (en) * 2007-02-23 2010-05-06 Schering Corporation Engineered anti-il-23p19 antibodies
EP2399604A1 (en) * 2010-06-25 2011-12-28 F. Hoffmann-La Roche AG Novel antibody formulation
PL3326649T3 (pl) * 2012-05-03 2022-04-25 Boehringer Ingelheim International Gmbh Przeciwciała anty-il-23p19
UA117466C2 (uk) * 2012-12-13 2018-08-10 Мерк Шарп Енд Доме Корп. СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19
AR102417A1 (es) * 2014-11-05 2017-03-01 Lilly Co Eli Anticuerpos biespecíficos anti-tnf- / anti-il-23
BR112017016636A2 (pt) * 2015-02-13 2018-04-03 Sanofi Sa formulação líquida estável para anticorpos monoclonais
CN112334483B (zh) * 2018-11-27 2022-05-10 信达生物制药(苏州)有限公司 抗IL-23p19抗体及其用途

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024255867A1 (zh) * 2023-06-16 2024-12-19 信达生物制药(苏州)有限公司 重组抗白介素23p19亚基抗体在治疗炎症性肠病中的用途

Also Published As

Publication number Publication date
KR20230009897A (ko) 2023-01-17
CA3178853A1 (en) 2021-11-18
TWI802882B (zh) 2023-05-21
EP4151233A4 (en) 2024-06-19
JP2023525825A (ja) 2023-06-19
US20230173069A1 (en) 2023-06-08
EP4151233A1 (en) 2023-03-22
BR112022022919A2 (pt) 2022-12-20
TW202200203A (zh) 2022-01-01
AU2021272212A1 (en) 2022-12-08
WO2021228113A1 (zh) 2021-11-18

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