CN113365665A - 抗Her2抗体药物偶联物药物制剂 - Google Patents

抗Her2抗体药物偶联物药物制剂 Download PDF

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CN113365665A
CN113365665A CN202080009504.3A CN202080009504A CN113365665A CN 113365665 A CN113365665 A CN 113365665A CN 202080009504 A CN202080009504 A CN 202080009504A CN 113365665 A CN113365665 A CN 113365665A
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pharmaceutical formulation
antibody
cancer
amino acid
concentration
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李壮林
徐巧玉
姚雪静
鲍倩婧
房健民
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Rongchang Biopharmaceutical Yantai Co Ltd
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Rongchang Biopharmaceutical Yantai Co Ltd
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    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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    • 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
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    • A61K47/6801Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/68031Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being an auristatin
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    • A61K47/6835Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6849Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a receptor, a cell surface antigen or a cell surface determinant
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    • A61K47/6851Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell
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    • A61K47/6889Conjugates wherein the antibody being the modifying agent and wherein the linker, binder or spacer confers particular properties to the conjugates, e.g. peptidic enzyme-labile linkers or acid-labile linkers, providing for an acid-labile immuno conjugate wherein the drug may be released from its antibody conjugated part in an acidic, e.g. tumoural or environment
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    • 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
    • C07K16/32Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
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    • 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
    • C07K2317/90Immunoglobulins 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

Abstract

本发明涉及一种包含非还原糖、重组人源化抗Her2单抗‑MMAE偶联物和一种表面活性剂的混合物的药物制剂。所述药物制剂具有减少颗粒物、减少聚集体形成、提高偶联物稳定性、改善冻干粉外观等特性。

Description

PCT国内申请,说明书已公开。

Claims (19)

  1. PCT国内申请,权利要求书已公开。
CN202080009504.3A 2019-03-26 2020-03-25 抗Her2抗体药物偶联物药物制剂 Pending CN113365665A (zh)

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CN201910231203 2019-03-26
CN2019102312034 2019-03-26
PCT/CN2020/081138 WO2020192693A1 (zh) 2019-03-26 2020-03-25 抗Her2抗体药物偶联物药物制剂

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CN113365665A true CN113365665A (zh) 2021-09-07

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US (1) US20210154314A1 (zh)
EP (2) EP3811979B1 (zh)
JP (2) JP7264986B2 (zh)
CN (1) CN113365665A (zh)
AU (2) AU2020239621B2 (zh)
BR (1) BR112021002290A2 (zh)
CA (1) CA3094194A1 (zh)
DK (1) DK3811979T3 (zh)
FI (1) FI3811979T3 (zh)
PT (1) PT3811979T (zh)
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CN113474360A (zh) 2019-02-18 2021-10-01 伊莱利利公司 治疗性抗体制剂
WO2023000171A1 (zh) * 2021-07-20 2023-01-26 浙江新码生物医药有限公司 一种含有抗her2-药物偶联物的冻干组合物、冻干制剂及其制备方法和用途
EP4353220A1 (en) * 2022-10-12 2024-04-17 Pierre Fabre Medicament Use of a liquid aqueous composition for solubilization and stabilization of an antibody-drug conjugate

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102892430A (zh) * 2010-03-17 2013-01-23 雅培研究有限公司 抗神经生长因子(ngf)抗体组合物
WO2015074528A1 (zh) * 2013-11-19 2015-05-28 烟台荣昌生物工程有限公司 抗her2抗体及其缀合物
CN105163763A (zh) * 2013-03-15 2015-12-16 阿布维德国有限责任两合公司 抗egfr抗体药物偶联物制剂
CN107847449A (zh) * 2015-07-10 2018-03-27 斯索恩生物制药有限公司 包含抗体‑倍癌霉素药物缀合物的组合物
WO2019039483A1 (ja) * 2017-08-23 2019-02-28 第一三共株式会社 抗体-薬物コンジュゲートの製剤及びその凍結乾燥方法

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050053666A1 (en) * 2002-12-31 2005-03-10 Stelios Tzannis Antibody-containing particles and compositions
EP3197500A1 (en) * 2014-09-17 2017-08-02 Genentech, Inc. Immunoconjugates comprising anti-her2 antibodies and pyrrolobenzodiazepines
CN106729743B (zh) * 2015-11-23 2021-09-21 四川科伦博泰生物医药股份有限公司 抗ErbB2抗体-药物偶联物及其组合物、制备方法和应用
CN109496149B (zh) * 2016-01-13 2022-10-14 根马布股份公司 抗体及其药物缀合物的制剂

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102892430A (zh) * 2010-03-17 2013-01-23 雅培研究有限公司 抗神经生长因子(ngf)抗体组合物
CN105163763A (zh) * 2013-03-15 2015-12-16 阿布维德国有限责任两合公司 抗egfr抗体药物偶联物制剂
WO2015074528A1 (zh) * 2013-11-19 2015-05-28 烟台荣昌生物工程有限公司 抗her2抗体及其缀合物
CN107847449A (zh) * 2015-07-10 2018-03-27 斯索恩生物制药有限公司 包含抗体‑倍癌霉素药物缀合物的组合物
WO2019039483A1 (ja) * 2017-08-23 2019-02-28 第一三共株式会社 抗体-薬物コンジュゲートの製剤及びその凍結乾燥方法

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EP4316521A3 (en) 2024-04-10
SG11202104269PA (en) 2021-05-28
FI3811979T3 (fi) 2024-01-11
AU2020239621B2 (en) 2023-09-21
KR20210068508A (ko) 2021-06-09
SI3811979T1 (sl) 2024-03-29
TWI825297B (zh) 2023-12-11
TW202102271A (zh) 2021-01-16
EP4316521A2 (en) 2024-02-07
PT3811979T (pt) 2024-01-02
AU2020239621A1 (en) 2020-10-22
BR112021002290A2 (pt) 2021-05-04
US20210154314A1 (en) 2021-05-27
WO2020192693A1 (zh) 2020-10-01
AU2023282237A1 (en) 2024-01-18
DK3811979T3 (da) 2024-01-02
EP3811979B1 (en) 2023-11-29
JP2023085555A (ja) 2023-06-20
JP2022511219A (ja) 2022-01-31

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