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EP4199965A4 - Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases - Google Patents

Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases

Info

Publication number
EP4199965A4
EP4199965A4 EP21857698.1A EP21857698A EP4199965A4 EP 4199965 A4 EP4199965 A4 EP 4199965A4 EP 21857698 A EP21857698 A EP 21857698A EP 4199965 A4 EP4199965 A4 EP 4199965A4
Authority
EP
European Patent Office
Prior art keywords
treating
humanized antibodies
high concentrations
related diseases
liquid formulations
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP21857698.1A
Other languages
German (de)
French (fr)
Other versions
EP4199965A1 (en
Inventor
Zhihao WU
Yong Wu
Yanyu Chen
Dandan HUANG
Xiaoping Luo
Kun ZHENG
Qingrui Li
Yili Yang
Yujie Liu
Cuihua Liu
Shengfeng Li
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.)
Bio Thera Solutions Ltd
Original Assignee
Bio Thera Solutions Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bio Thera Solutions Ltd filed Critical Bio Thera Solutions Ltd
Publication of EP4199965A1 publication Critical patent/EP4199965A1/en
Publication of EP4199965A4 publication Critical patent/EP4199965A4/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • 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
    • A61K47/26Carbohydrates, 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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

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)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Rheumatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
EP21857698.1A 2020-08-19 2021-08-18 Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases Pending EP4199965A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN2020109965 2020-08-19
PCT/CN2021/113241 WO2022037606A1 (en) 2020-08-19 2021-08-18 Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases

Publications (2)

Publication Number Publication Date
EP4199965A1 EP4199965A1 (en) 2023-06-28
EP4199965A4 true EP4199965A4 (en) 2025-03-26

Family

ID=80322555

Family Applications (1)

Application Number Title Priority Date Filing Date
EP21857698.1A Pending EP4199965A4 (en) 2020-08-19 2021-08-18 Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases

Country Status (3)

Country Link
EP (1) EP4199965A4 (en)
CN (1) CN116261448A (en)
WO (1) WO2022037606A1 (en)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10961314B2 (en) * 2016-09-27 2021-03-30 Fresenius Kabi Deutschland Gmbh Liquid pharmaceutical composition comprising an anti-IL-6 receptor antibody
WO2023020563A1 (en) * 2021-08-18 2023-02-23 Bio-Thera Solutions, Ltd. Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases
WO2024245170A1 (en) * 2023-05-26 2024-12-05 Bio-Thera Solutions, Ltd. Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10022319B2 (en) * 2010-01-20 2018-07-17 Chugai Seiyaku Kabushiki Kaisha Stabilized antibody-containing liquid formulations
WO2019105450A1 (en) * 2017-11-30 2019-06-06 百奥泰生物制药股份有限公司 Liquid preparation of humanized antibody for treating il-6-related disease
WO2023020563A1 (en) * 2021-08-18 2023-02-23 Bio-Thera Solutions, Ltd. Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160058863A1 (en) * 2014-09-03 2016-03-03 Board Of Regents, The University Of Texas System Low viscosity concentrated protein dispersions
CN108718522A (en) * 2016-02-23 2018-10-30 赛森生物股份有限公司 IL-6 antagonist formulations and application thereof
WO2017201731A1 (en) * 2016-05-27 2017-11-30 Beijing Vdjbio Co., Ltd. Antibodies, composition and kits comprising same, and methods of use thereof
US10961314B2 (en) * 2016-09-27 2021-03-30 Fresenius Kabi Deutschland Gmbh Liquid pharmaceutical composition comprising an anti-IL-6 receptor antibody
CN111432828A (en) * 2017-05-26 2020-07-17 约翰霍普金斯大学 Multifunctional Antibody-Ligand Capture Agents for Modulating Immune Tolerance
CN111110841A (en) * 2018-10-31 2020-05-08 上海君实生物医药科技股份有限公司 Stable formulation containing anti-PCSK9 antibody

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10022319B2 (en) * 2010-01-20 2018-07-17 Chugai Seiyaku Kabushiki Kaisha Stabilized antibody-containing liquid formulations
WO2019105450A1 (en) * 2017-11-30 2019-06-06 百奥泰生物制药股份有限公司 Liquid preparation of humanized antibody for treating il-6-related disease
WO2023020563A1 (en) * 2021-08-18 2023-02-23 Bio-Thera Solutions, Ltd. Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
KANG JICHAO ET AL: "Rapid Formulation Development for Monoclonal Antibodies", vol. 14, no. 4, 12 April 2016 (2016-04-12), pages 40, 42, 44, 46, XP009532716, ISSN: 1542-6319, Retrieved from the Internet <URL:https://bioprocessintl.com/manufacturing/formulation/rapid-formulation-development-for-monoclonal-antibodies/> *
See also references of WO2022037606A1 *

Also Published As

Publication number Publication date
EP4199965A1 (en) 2023-06-28
WO2022037606A1 (en) 2022-02-24
CN116261448A (en) 2023-06-13

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