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MX2022010217A - Composicion farmaceutica que contiene anticuerpo anti-il-4r y uso de la misma. - Google Patents

Composicion farmaceutica que contiene anticuerpo anti-il-4r y uso de la misma.

Info

Publication number
MX2022010217A
MX2022010217A MX2022010217A MX2022010217A MX2022010217A MX 2022010217 A MX2022010217 A MX 2022010217A MX 2022010217 A MX2022010217 A MX 2022010217A MX 2022010217 A MX2022010217 A MX 2022010217A MX 2022010217 A MX2022010217 A MX 2022010217A
Authority
MX
Mexico
Prior art keywords
antibody
pharmaceutical composition
composition containing
containing anti
histidine
Prior art date
Application number
MX2022010217A
Other languages
English (en)
Inventor
Zhen Yan
Tingting Wu
Xun Liu
Original Assignee
Jiangsu Hengrui Pharmaceuticals Co 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 Jiangsu Hengrui Pharmaceuticals Co Ltd filed Critical Jiangsu Hengrui Pharmaceuticals Co Ltd
Publication of MX2022010217A publication Critical patent/MX2022010217A/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K9/0012—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
    • A61K9/14—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
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [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
    • 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
    • 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
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • 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
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • 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)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Pulmonology (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Se proporciona una composición farmacéutica que contiene un anticuerpo anti-IL-4R y el uso del mismo. La composición farmacéutica contiene un anticuerpo anti-IL-4R o un fragmento de unión a antígeno del mismo en un agente amortiguador de ácido acético-histidina, un modificador de la viscosidad, un tensioactivo y un estabilizador.
MX2022010217A 2020-02-21 2021-02-19 Composicion farmaceutica que contiene anticuerpo anti-il-4r y uso de la misma. MX2022010217A (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN202010107765 2020-02-21
CN202110145455 2021-02-02
PCT/CN2021/076854 WO2021164728A1 (zh) 2020-02-21 2021-02-19 一种抗il-4r抗体药物组合物及其用途

Publications (1)

Publication Number Publication Date
MX2022010217A true MX2022010217A (es) 2022-09-19

Family

ID=77390440

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2022010217A MX2022010217A (es) 2020-02-21 2021-02-19 Composicion farmaceutica que contiene anticuerpo anti-il-4r y uso de la misma.

Country Status (11)

Country Link
US (1) US20230088052A1 (es)
EP (1) EP4104858A4 (es)
JP (1) JP7752620B2 (es)
KR (1) KR20220143882A (es)
CN (1) CN114980926A (es)
AU (1) AU2021223128A1 (es)
BR (1) BR112022016345A2 (es)
CA (1) CA3169959A1 (es)
MX (1) MX2022010217A (es)
TW (1) TWI865727B (es)
WO (1) WO2021164728A1 (es)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN119215163A (zh) * 2023-06-30 2024-12-31 百奥泰生物制药股份有限公司 抗IL-4Rα抗体制剂及其制备方法和应用
WO2025116648A1 (ko) * 2023-12-01 2025-06-05 삼성바이오에피스 주식회사 항-IL-4Rα 항체의 안정한 완충제-프리 액상 제형
CN118105485B (zh) * 2024-04-26 2024-09-03 湖南麦济生物技术有限公司 一种稳定的抗人IL-4Rα单克隆抗体制剂
WO2025247342A1 (zh) * 2024-05-30 2025-12-04 重庆智翔金泰生物制药股份有限公司 包含抗il-4r抗体的药物组合物
WO2026025028A1 (en) * 2024-07-26 2026-01-29 Regeneron Pharmaceuticals, Inc. Methods of making ultra-high concentrated protein formulations using lyophilization

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5641870A (en) 1995-04-20 1997-06-24 Genentech, Inc. Low pH hydrophobic interaction chromatography for antibody purification
ES2614260T3 (es) 2000-05-26 2017-05-30 Immunex Corporation Uso de anticuerpos contra el receptor de interleuquina-4 y composiciones de los mismos
CN101495136A (zh) * 2006-02-15 2009-07-29 英克隆系统公司 抗体配制品
US7608693B2 (en) 2006-10-02 2009-10-27 Regeneron Pharmaceuticals, Inc. High affinity human antibodies to human IL-4 receptor
NZ576040A (en) 2006-10-02 2011-06-30 Regeneron Pharma High affinity human antibodies to human il-4 receptor
PT2624865T (pt) * 2010-10-06 2018-11-05 Regeneron Pharma Formulações estabilizadas que contêm anticorpos anti-recetor de interleucina-4 (il-4r)
WO2014031610A1 (en) 2012-08-21 2014-02-27 Sanofi Methods for treating or preventing asthma by administering an il-4r antagonist
US20170281769A1 (en) 2014-09-03 2017-10-05 Medimmune Limited STABLE ANTI-IL-4Ra FORMULATION
AU2017330346C1 (en) * 2016-09-21 2025-03-06 Nextcure, Inc. Antibodies for Siglec-15 and methods of use thereof
TWI720325B (zh) * 2017-06-30 2021-03-01 大陸商江蘇恒瑞醫藥股份有限公司 一種pcsk-9抗體醫藥組成物及其用途
CN111686247B (zh) * 2019-03-13 2022-07-29 苏州康乃德生物医药有限公司 包含人白介素-4受体α的抗体的液体组合物
CN114652853B (zh) * 2020-12-22 2024-09-13 江苏恒瑞医药股份有限公司 抗il-4r抗体-药物偶联物及医药用途

Also Published As

Publication number Publication date
US20230088052A1 (en) 2023-03-23
CA3169959A1 (en) 2021-08-26
AU2021223128A1 (en) 2022-09-08
JP2023515423A (ja) 2023-04-13
JP7752620B2 (ja) 2025-10-10
EP4104858A1 (en) 2022-12-21
KR20220143882A (ko) 2022-10-25
WO2021164728A1 (zh) 2021-08-26
CN114980926A (zh) 2022-08-30
EP4104858A4 (en) 2023-11-29
TWI865727B (zh) 2024-12-11
TW202139974A (zh) 2021-11-01
BR112022016345A2 (pt) 2022-12-20

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