CN110198739A - 一种pd-l1抗体药物组合物及其用途 - Google Patents

一种pd-l1抗体药物组合物及其用途 Download PDF

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Publication number
CN110198739A
CN110198739A CN201880007923.6A CN201880007923A CN110198739A CN 110198739 A CN110198739 A CN 110198739A CN 201880007923 A CN201880007923 A CN 201880007923A CN 110198739 A CN110198739 A CN 110198739A
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seq
antibody
pharmaceutical composition
antigen
binding fragment
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CN110198739B (zh
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颜贞
杨健健
颜晓丹
吴珊
刘洵
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Suzhou Suncadia Biopharmaceuticals Co Ltd
Shanghai Shengdi Pharmaceutical Co Ltd
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Jiangsu Hengrui Medicine Co Ltd
Shanghai Hengrui Pharmaceutical Co Ltd
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    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • 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
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • 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
    • 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
    • C07K16/2803Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2827Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against B7 molecules, e.g. CD80, CD86
    • 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
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)

Abstract

本发明提供了一种PD‑L1抗体药物组合物及其用途。具体而言,本发明提供了一种药物组合物,其包含琥珀酸盐缓冲剂中的PD‑L1抗体或其抗原结合片段。除此之外,该药物组合物还可含有糖和非离子表面活性剂。

Description

PCT国内申请,说明书已公开。

Claims (18)

  1. PCT国内申请,权利要求书已公开。
CN201880007923.6A 2017-05-16 2018-05-15 一种pd-l1抗体药物组合物及其用途 Active CN110198739B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN2017103416807 2017-05-16
CN201710341680 2017-05-16
PCT/CN2018/086866 WO2018210230A1 (zh) 2017-05-16 2018-05-15 一种pd-l1抗体药物组合物及其用途

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CN110198739A true CN110198739A (zh) 2019-09-03
CN110198739B CN110198739B (zh) 2023-04-04

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US (1) US11654194B2 (zh)
EP (1) EP3626266A4 (zh)
JP (1) JP7263256B6 (zh)
KR (1) KR102623679B1 (zh)
CN (1) CN110198739B (zh)
AU (1) AU2018267843A1 (zh)
BR (1) BR112019023846A2 (zh)
CA (1) CA3062487A1 (zh)
MX (1) MX2019013751A (zh)
MY (1) MY195465A (zh)
RU (1) RU2766590C2 (zh)
TW (1) TWI734916B (zh)
WO (1) WO2018210230A1 (zh)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112618482A (zh) * 2019-09-24 2021-04-09 江苏恒瑞医药股份有限公司 新型蛋白制剂

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR112018009064A8 (pt) * 2015-11-17 2019-02-26 Jiangsu Hengrui Medicine Co anticorpo de pd-l1, fragmento de ligação ao antígeno do mesmo e aplicação médica do mesmo
WO2020108497A1 (zh) * 2018-11-29 2020-06-04 和铂医药(香港)有限公司 一种抗pd-l1抗体制剂
BR112021013415A2 (pt) * 2019-01-07 2021-12-28 Univ Jefferson Proteínas de fusão multifuncionais e usos das mesmas
CN112125975B (zh) * 2019-06-25 2024-03-01 上海翰森生物医药科技有限公司 Pd-l1和cd47双特异性融合蛋白及其医药用途
WO2021006199A1 (ja) 2019-07-05 2021-01-14 小野薬品工業株式会社 Pd-1/cd3二重特異性タンパク質による血液がん治療
WO2021025140A1 (ja) 2019-08-08 2021-02-11 小野薬品工業株式会社 二重特異性タンパク質
CA3227991A1 (en) * 2021-07-29 2023-02-02 Shanghai Junshi Biosciences Co., Ltd. Anti-pd-1 antibody pharmaceutical composition and use thereof
TW202333789A (zh) * 2022-01-05 2023-09-01 大陸商上海邁晉生物醫藥科技有限公司 一種包含抗FXI/FXIa抗體的醫藥組成物及其用途

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CN102245640A (zh) * 2008-12-09 2011-11-16 霍夫曼-拉罗奇有限公司 抗-pd-l1抗体及它们用于增强t细胞功能的用途

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DE69810481T2 (de) * 1997-06-13 2003-09-25 Genentech Inc Stabilisierte antikörperformulierung
PT1441589E (pt) * 2001-11-08 2012-08-13 Abbott Biotherapeutics Corp Formulação farmacêutica líquida estável de anticorpos igg
SI1907424T1 (sl) * 2005-07-01 2015-12-31 E. R. Squibb & Sons, L.L.C. Humana monoklonska protitelesa proti programiranem smrtnem ligandu 1 (PD-L1)
EP3279215B1 (en) 2009-11-24 2020-02-12 MedImmune Limited Targeted binding agents against b7-h1
LT2691112T (lt) 2011-03-31 2018-07-25 Merck Sharp & Dohme Corp. Stabilios antikūnų kompozicijos prieš žmogaus programuojamos mirties receptorių pd-1 ir susiję gydymo būdai
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Cited By (1)

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Publication number Priority date Publication date Assignee Title
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RU2019139093A3 (zh) 2021-08-10
CN110198739B (zh) 2023-04-04
JP7263256B2 (ja) 2023-04-24
KR20200005650A (ko) 2020-01-15
KR102623679B1 (ko) 2024-01-11
RU2766590C2 (ru) 2022-03-15
AU2018267843A1 (en) 2019-12-12
BR112019023846A2 (pt) 2020-06-09
RU2019139093A (ru) 2021-06-16
EP3626266A1 (en) 2020-03-25
JP7263256B6 (ja) 2023-07-24
MX2019013751A (es) 2020-01-15
JP2020520939A (ja) 2020-07-16
TW201900211A (zh) 2019-01-01
TWI734916B (zh) 2021-08-01
US20200069800A1 (en) 2020-03-05
CA3062487A1 (en) 2018-11-22
MY195465A (en) 2023-01-25
US11654194B2 (en) 2023-05-23
EP3626266A4 (en) 2021-04-07
WO2018210230A1 (zh) 2018-11-22
WO2018210230A8 (zh) 2019-09-26

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