CN112839961A - 一种cd40抗体药物组合物及其用途 - Google Patents

一种cd40抗体药物组合物及其用途 Download PDF

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Publication number
CN112839961A
CN112839961A CN201980067049.XA CN201980067049A CN112839961A CN 112839961 A CN112839961 A CN 112839961A CN 201980067049 A CN201980067049 A CN 201980067049A CN 112839961 A CN112839961 A CN 112839961A
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antibody
seq
pharmaceutical composition
buffer
antigen
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CN201980067049.XA
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CN112839961B (zh
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杨健健
李皓
刘洵
蒋家骅
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Jiangsu Hengrui Medicine Co Ltd
Shanghai Hengrui Pharmaceutical Co Ltd
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Jiangsu Hengrui Medicine Co Ltd
Shanghai Hengrui Pharmaceutical Co Ltd
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    • 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
    • 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
    • A61K47/06—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • 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
    • C07K16/2878—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • 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
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • 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

Abstract

本发明提供了一种包含CD40抗体或其抗原结合片段以及醋酸‑醋酸钠缓冲液的药物组合物及其用途。所述药物组合物还可含有糖、非离子型表面活性剂和其他辅料。本发明的药物组合物展现了良好的抗体稳定性。

Description

PCT国内申请，说明书已公开。

Claims (20)

  1. PCT国内申请，权利要求书已公开。
CN201980067049.XA 2018-11-30 2019-11-29 一种cd40抗体药物组合物及其用途 Active CN112839961B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN201811448238 2018-11-30
CN2018114482385 2018-11-30
PCT/CN2019/121985 WO2020108621A1 (zh) 2018-11-30 2019-11-29 一种cd40抗体药物组合物及其用途

Publications (2)

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CN112839961A true CN112839961A (zh) 2021-05-25
CN112839961B CN112839961B (zh) 2023-04-04

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EP (1) EP3939998A4 (zh)
JP (1) JP2022513671A (zh)
KR (1) KR20210097750A (zh)
CN (1) CN112839961B (zh)
AU (1) AU2019388931A1 (zh)
BR (1) BR112021010414A2 (zh)
CA (1) CA3121291A1 (zh)
MX (1) MX2021006360A (zh)
TW (1) TW202021620A (zh)
WO (1) WO2020108621A1 (zh)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3232171A1 (en) * 2021-09-24 2023-03-30 Zhenzhen Lu Anti-cd40 antibody and use thereof

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1897971A (zh) * 2003-12-22 2007-01-17 辉瑞产品公司 Cd40抗体制剂和方法
CN107922501A (zh) * 2015-09-01 2018-04-17 勃林格殷格翰国际有限公司 抗cd40抗体用于治疗狼疮性肾炎的用途
CN110267989A (zh) * 2017-06-01 2019-09-20 江苏恒瑞医药股份有限公司 抗cd40抗体、其抗原结合片段及其医药用途

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH10308991A (ja) 1997-05-07 1998-11-17 Mitsubishi Electric Corp スピーカー取付構造
US6946129B1 (en) 1999-06-08 2005-09-20 Seattle Genetics, Inc. Recombinant anti-CD40 antibody and uses thereof
US20030059427A1 (en) 2000-04-28 2003-03-27 Force Walker R. Isolation and characterization of highly active anti-CD40 antibody
DE60143535D1 (de) 2000-10-02 2011-01-05 Novartis Vaccines & Diagnostic Humane antikörper gegen cd40
AR039067A1 (es) 2001-11-09 2005-02-09 Pfizer Prod Inc Anticuerpos para cd40
WO2006073443A2 (en) 2004-04-27 2006-07-13 Novartis Vaccines And Diagnostics, Inc. Antagonist anti-cd40 monoclonal antibodies and methods for their use
BRPI0610470A2 (pt) 2005-05-26 2010-06-22 Seattle Genetics Inc anticorpo isolado ou fragmento de ligação a antìgeno que especificamente se liga a cd40 humano, kit, composição farmacêutica, e, polinucleotìdeo isolado
EP1854810A1 (en) 2006-05-09 2007-11-14 PanGenetics B.V. Deimmunized antagonistic anti-human CD40 monoclonal antibody from the ch5D12 antibody
WO2011123489A2 (en) 2010-03-31 2011-10-06 Boehringer Ingelheim International Gmbh Anti-cd40 antibodies
CN106977604A (zh) 2011-04-21 2017-07-25 百时美施贵宝公司 拮抗cd40之抗体多肽
MX339239B (es) 2011-04-29 2016-05-18 Apexigen Inc Anticuerpos anti-cd40 y metodos de uso.
GB201115280D0 (en) 2011-09-05 2011-10-19 Alligator Bioscience Ab Antibodies, uses and methods
CN104918957B (zh) 2012-10-30 2018-11-16 埃派斯进有限公司 抗-cd40抗体及其使用方法
GB201322583D0 (en) 2013-12-19 2014-02-05 Alligator Bioscience Ab Antibodies
WO2016115475A1 (en) * 2015-01-18 2016-07-21 Biogen Ma Inc. Anti-cd40 antibody formulations
CA2987051A1 (en) 2015-05-29 2016-12-08 Abbvie Inc. Anti-cd40 antibodies and uses thereof
US20180142030A1 (en) 2015-06-29 2018-05-24 Bristol-Myers Squibb Company Antibodies to cd40
SI3307322T1 (sl) 2015-09-04 2021-08-31 Primatope Therapeutics Inc. Humanizirana protitelesa proti CD40 in njihove uporabe

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1897971A (zh) * 2003-12-22 2007-01-17 辉瑞产品公司 Cd40抗体制剂和方法
CN107922501A (zh) * 2015-09-01 2018-04-17 勃林格殷格翰国际有限公司 抗cd40抗体用于治疗狼疮性肾炎的用途
CN110267989A (zh) * 2017-06-01 2019-09-20 江苏恒瑞医药股份有限公司 抗cd40抗体、其抗原结合片段及其医药用途

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Publication number Publication date
AU2019388931A1 (en) 2021-07-15
MX2021006360A (es) 2021-08-11
CA3121291A1 (en) 2020-06-04
WO2020108621A1 (zh) 2020-06-04
EP3939998A4 (en) 2022-08-10
EP3939998A1 (en) 2022-01-19
TW202021620A (zh) 2020-06-16
KR20210097750A (ko) 2021-08-09
JP2022513671A (ja) 2022-02-09
BR112021010414A2 (pt) 2021-09-08
CN112839961B (zh) 2023-04-04

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