BR112022016345A2 - Composição farmacêutica contendo anticorpo anti-il-4r e uso da mesma - Google Patents

Composição farmacêutica contendo anticorpo anti-il-4r e uso da mesma

Info

Publication number
BR112022016345A2
BR112022016345A2 BR112022016345A BR112022016345A BR112022016345A2 BR 112022016345 A2 BR112022016345 A2 BR 112022016345A2 BR 112022016345 A BR112022016345 A BR 112022016345A BR 112022016345 A BR112022016345 A BR 112022016345A BR 112022016345 A2 BR112022016345 A2 BR 112022016345A2
Authority
BR
Brazil
Prior art keywords
antibody
pharmaceutical composition
composition containing
containing anti
histidine
Prior art date
Application number
BR112022016345A
Other languages
English (en)
Inventor
Wu Tingting
Yan Zhen
Liu Xun
Original Assignee
Jiangsu Hengrui Pharmaceuticals Co Ltd
Shanghai hengrui pharmaceutical 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, Shanghai hengrui pharmaceutical co ltd filed Critical Jiangsu Hengrui Pharmaceuticals Co Ltd
Publication of BR112022016345A2 publication Critical patent/BR112022016345A2/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, 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)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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

COMPOSIÇÃO FARMACÊUTICA CONTENDO ANTICORPO ANTI-IL-4R E USO DA MESMA. É provida uma composição farmacêutica contendo um anticorpo anti-IL-4R e uso da mesma. A composição farmacêutica contém um anticorpo anti-IL-4R ou um fragmento de ligação ao antígeno do mesmo em um agente tampão de histidina-ácido acético, um modificador de viscosidade, um tensoativo e um estabilizador.
BR112022016345A 2020-02-21 2021-02-19 Composição farmacêutica contendo anticorpo anti-il-4r e uso da mesma BR112022016345A2 (pt)

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
BR112022016345A2 true BR112022016345A2 (pt) 2022-12-20

Family

ID=77390440

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112022016345A BR112022016345A2 (pt) 2020-02-21 2021-02-19 Composição farmacêutica contendo anticorpo anti-il-4r e uso da mesma

Country Status (11)

Country Link
US (1) US20230088052A1 (pt)
EP (1) EP4104858A4 (pt)
JP (1) JP2023515423A (pt)
KR (1) KR20220143882A (pt)
CN (1) CN114980926A (pt)
AU (1) AU2021223128A1 (pt)
BR (1) BR112022016345A2 (pt)
CA (1) CA3169959A1 (pt)
MX (1) MX2022010217A (pt)
TW (1) TW202139974A (pt)
WO (1) WO2021164728A1 (pt)

Family Cites Families (9)

* 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
CA2409267C (en) 2000-05-26 2017-02-28 Immunex Corporation Interleukin-4 antagonists and compositions thereof
US7608693B2 (en) 2006-10-02 2009-10-27 Regeneron Pharmaceuticals, Inc. High affinity human antibodies to human IL-4 receptor
PT2069403E (pt) 2006-10-02 2014-07-18 Regeneron Pharma Anticorpos humanos com elevada afinidade para o receptor de il-4 humana
EA034617B1 (ru) * 2010-10-06 2020-02-27 Ридженерон Фармасьютикалз, Инк. Дозированная форма жидкой фармацевтической композиции, содержащей антитела к рецептору интерлейкина-4 (il-4r)
TWI656880B (zh) 2012-08-21 2019-04-21 法商賽諾菲生物技術公司 投與il-4r拮抗劑以治療或預防氣喘之方法
US20170281769A1 (en) * 2014-09-03 2017-10-05 Medimmune Limited STABLE ANTI-IL-4Ra FORMULATION
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
CN114652853A (zh) * 2020-12-22 2022-06-24 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
CA3169959A1 (en) 2021-08-26
EP4104858A1 (en) 2022-12-21
AU2021223128A1 (en) 2022-09-08
MX2022010217A (es) 2022-09-19
KR20220143882A (ko) 2022-10-25
TW202139974A (zh) 2021-11-01
JP2023515423A (ja) 2023-04-13
EP4104858A4 (en) 2023-11-29
US20230088052A1 (en) 2023-03-23
WO2021164728A1 (zh) 2021-08-26
CN114980926A (zh) 2022-08-30

Similar Documents

Publication Publication Date Title
BR112021019731A2 (pt) Composições para tratamento bucal para liberação de agente ativo
BR112018075288A2 (pt) métodos para diagnóstico de infecções bacterianas e virais
CL2016002585A1 (es) Inmunoconjugado que comprende una proteína de unión a antígeno que se une a antígeno de maduración de linfocitos b (bcma) y un agente citotóxico, composición farmacéutica y su uso (divisional solicitud 201303373)
BR112018015824A2 (pt) composições para higiene pessoal
BR112022008817A2 (pt) Terapias combinadas para tratamento de câncer
AR080795A1 (es) Anticuerpos anti-lrp6 (proteina relacionada con el receptor ldl tipo 6)
BR112017003419A2 (pt) formulação de anticorpo anti-il-4r-alfa estável
BR112014016668A2 (pt) composições para cuidados pessoais contendo silicone iônico e agente formador de filme
BR112016002241A2 (pt) composições de adoçante
BR112021021857A2 (pt) Métodos para formação de complexos de inclusão com derivados de beta-ciclodextrina hidrofílicos e composições dos mesmos
BRPI0509053A (pt) composição farmacêutica anidra e uso de um agente siliconado e de uma composição
BR112017013383A2 (pt) método de cimentação, sistema de cimentação, e, composição para cimentação de poço
BR112018006504A2 (pt) formulação solúvel em água, e, uso das formulações solúveis em água.
BR112017022971A2 (pt) aperfeiçoamentos em ou com relação a compostos orgânicos
BR112021013397A2 (pt) Anticorpos anti-tigit
CL2017002214A1 (es) Formulación de combinación de tesofensina y betabloqueante
BR112021012056A2 (pt) Inibidor da expressão gênica do hbv, agente que reduz a carga antigênica de hbv, composições para uso no tratamento de uma infecção crônica por hbv, usos de um inibidor da expressão gênica do hbv e de um agente que reduz a carga antigênica de hbv, métodos de tratamento da infecção crônica por hbv e kit
BR112018007175A2 (pt) composição de pós-revestimento para fibras de reforço
BR112018074823A2 (pt) formulações de óxido de polialquileno asparaginase e métodos de fabricação e uso do mesmo
BR112023001471A2 (pt) Composição farmacêutica de anticorpo anti-pd-1 e uso da mesma
BR112022016345A2 (pt) Composição farmacêutica contendo anticorpo anti-il-4r e uso da mesma
BR112023002923A2 (pt) Formulação farmacêutica que compreende um bite, anticorpo bespecífico, e metionina
WO2021067823A3 (en) A new treatment for meibomian gland dysfunction
MX2019014666A (es) Composicion farmaceutica que comprende un conjugado de anticuerpo contra c-met-farmaco y uso del mismo.
BR112022009506A2 (pt) Composições de ciclodextrina alquilada e processos para preparação e uso das mesmas