CN108341871A - 抗pd-1单克隆抗体及其制备方法和应用 - Google Patents

抗pd-1单克隆抗体及其制备方法和应用 Download PDF

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Publication number
CN108341871A
CN108341871A CN201710054783.5A CN201710054783A CN108341871A CN 108341871 A CN108341871 A CN 108341871A CN 201710054783 A CN201710054783 A CN 201710054783A CN 108341871 A CN108341871 A CN 108341871A
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ser
seq
human
monoclonal antibody
val
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Chinese (zh)
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赵杰
高宏海
郭锦林
党尉
朱玲巧
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Three Country Kin Pharmaceutical (shanghai) Ltd By Share Ltd
Sunshine Guojian Pharmaceutical Shanghai Co Ltd
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Three Country Kin Pharmaceutical (shanghai) Ltd By Share Ltd
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Priority to CN201710054783.5A priority Critical patent/CN108341871A/zh
Priority to US16/480,014 priority patent/US11254746B2/en
Priority to EP18745412.9A priority patent/EP3575322B1/en
Priority to JP2019536981A priority patent/JP7098629B2/ja
Priority to PCT/CN2018/073575 priority patent/WO2018137576A1/zh
Priority to CN201880007287.7A priority patent/CN110225928B/zh
Publication of CN108341871A publication Critical patent/CN108341871A/zh
Pending legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], 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
    • C07K16/2827—Immunoglobulins [IG], 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], 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
    • C07K16/2818—Immunoglobulins [IG], 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 CD28 or CD152
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • 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
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • 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
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79—Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/85—Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/10—Cells modified by introduction of foreign genetic material
    • 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
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
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    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
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  • Biophysics (AREA)
  • Zoology (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Wood Science & Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Plant Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Cell Biology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Transplantation (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
CN201710054783.5A 2017-01-24 2017-01-24 抗pd-1单克隆抗体及其制备方法和应用 Pending CN108341871A (zh)

Priority Applications (6)

Application Number Priority Date Filing Date Title
CN201710054783.5A CN108341871A (zh) 2017-01-24 2017-01-24 抗pd-1单克隆抗体及其制备方法和应用
US16/480,014 US11254746B2 (en) 2017-01-24 2018-01-22 Anti-PD-1 monoclonal antibody, and preparation method therefor and application thereof
EP18745412.9A EP3575322B1 (en) 2017-01-24 2018-01-22 Anti-pd-1 monoclonal antibody, and preparation method therefor and application thereof
JP2019536981A JP7098629B2 (ja) 2017-01-24 2018-01-22 抗ｐｄ－１モノクローナル抗体、その製造方法及び用途
PCT/CN2018/073575 WO2018137576A1 (zh) 2017-01-24 2018-01-22 抗pd-1单克隆抗体及其制备方法和应用
CN201880007287.7A CN110225928B (zh) 2017-01-24 2018-01-22 抗pd-1单克隆抗体及其制备方法和应用

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US (1) US11254746B2 (cg-RX-API-DMAC10.html)
EP (1) EP3575322B1 (cg-RX-API-DMAC10.html)
JP (1) JP7098629B2 (cg-RX-API-DMAC10.html)
CN (2) CN108341871A (cg-RX-API-DMAC10.html)
WO (1) WO2018137576A1 (cg-RX-API-DMAC10.html)

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CN109748965A (zh) * 2019-03-13 2019-05-14 安徽安科生物工程（集团）股份有限公司 全人源pd-l1单克隆抗体及其制备方法和应用
CN109929037A (zh) * 2019-04-01 2019-06-25 华博生物医药技术（上海）有限公司 针对程序性死亡配体的结合物及其应用
CN110563849A (zh) * 2019-08-09 2019-12-13 安徽瀚海博兴生物技术有限公司 一种全新序列的抗vegf-抗pd1双特异性抗体
CN111196855A (zh) * 2018-11-19 2020-05-26 三生国健药业（上海）股份有限公司 抗egfr/pd-1双特异性抗体
WO2020103629A1 (zh) * 2018-11-19 2020-05-28 三生国健药业（上海）股份有限公司 抗her2/pd1双特异性抗体
WO2020156222A1 (zh) * 2019-02-01 2020-08-06 长春金赛药业有限责任公司 人源化抗Aβ单克隆抗体及其应用
CN113150154A (zh) * 2021-04-15 2021-07-23 博奥信生物技术（南京）有限公司 抗人pdl1单克隆抗体及其用途
WO2021249551A1 (zh) * 2020-06-11 2021-12-16 三生国健药业（上海）股份有限公司 一种抗pd-1单克隆抗体液体制剂
WO2022068891A1 (zh) * 2020-09-30 2022-04-07 苏州沙砾生物科技有限公司 Pd-1抗体及其制备方法与应用
CN114316047A (zh) * 2021-01-14 2022-04-12 东大生物技术(苏州)有限公司 一组pd-1单克隆抗体及其医药用途
CN114539407A (zh) * 2021-12-31 2022-05-27 浙江大学 一种全人源抗PD-1的单克隆抗体No.1-10及其应用
CN114539406A (zh) * 2021-12-31 2022-05-27 浙江大学 一种全人源抗PD-1的单克隆抗体No.8-3及其应用
CN120078772A (zh) * 2025-03-11 2025-06-03 上海交通大学医学院附属仁济医院 A61603作为抗肝癌治疗药物的应用

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CN115038718B (zh) * 2019-11-08 2024-07-02 山东先声生物制药有限公司 抗人程序性死亡配体-1（pd-l1）的抗体及其用途
CN113563473A (zh) 2020-04-29 2021-10-29 三生国健药业（上海）股份有限公司 四价双特异性抗体、其制备方法和用途
WO2021226984A1 (zh) * 2020-05-15 2021-11-18 三生国健药业（上海）股份有限公司 一种抗pd-1和pd-l1的四价双特异性抗体
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CN113754767A (zh) * 2020-06-03 2021-12-07 上海恒润达生生物科技股份有限公司 抗人pd-1抗体及其用途
CN111647624A (zh) * 2020-06-10 2020-09-11 成都和同易创生物科技有限公司 Tsab人源单克隆抗体重组载体、重组抗体及其制备方法
US20250270320A1 (en) * 2020-12-10 2025-08-28 Eutilex Co., Ltd. Anti-pd-1 antibody and uses thereof
CN113980129B (zh) * 2021-01-15 2023-07-28 东大生物技术(苏州)有限公司 一组il-11单克隆抗体及其医药用途
CN115536749A (zh) * 2021-06-29 2022-12-30 三生国健药业（上海）股份有限公司 三特异性抗体、其制备方法和用途
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CN115925947B (zh) * 2022-09-27 2023-08-22 上海百英生物科技股份有限公司 一种亲和力成熟方法及抗人pd-l1单域抗体的亲和力成熟
CN115951055B (zh) * 2022-12-13 2024-10-15 湖南湘医投蕙尧生命科技有限公司 一种癌症相关蛋白及其抗体和应用
WO2025128263A1 (en) * 2023-12-15 2025-06-19 Pharmaessentia Corporation Anti-pd-1 monoclonal antibody and methods of preparation thereof
CN120518767B (zh) * 2025-05-30 2025-11-11 中国人民解放军军事科学院军事医学研究院 一种pd-1单克隆抗体及其应用
CN121021692A (zh) * 2025-06-23 2025-11-28 上海百英生物科技股份有限公司 一种具有阻断活性的抗人pd-1单克隆抗体或其抗原结合片段及其应用

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Cited By (25)

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WO2020103629A1 (zh) * 2018-11-19 2020-05-28 三生国健药业（上海）股份有限公司 抗her2/pd1双特异性抗体
CN111196855B (zh) * 2018-11-19 2022-11-15 三生国健药业（上海）股份有限公司 抗egfr/pd-1双特异性抗体
US12384853B2 (en) 2018-11-19 2025-08-12 Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. Anti-HER2/PD1 bispecific antibody
CN111196855A (zh) * 2018-11-19 2020-05-26 三生国健药业（上海）股份有限公司 抗egfr/pd-1双特异性抗体
WO2020156222A1 (zh) * 2019-02-01 2020-08-06 长春金赛药业有限责任公司 人源化抗Aβ单克隆抗体及其应用
US12258386B2 (en) 2019-02-01 2025-03-25 Changchun Genescience Pharmaceutical Co., Ltd. Humanized anti-A β monoclonal antibody and application thereof
CN109748965A (zh) * 2019-03-13 2019-05-14 安徽安科生物工程（集团）股份有限公司 全人源pd-l1单克隆抗体及其制备方法和应用
CN109929037B (zh) * 2019-04-01 2023-03-17 华博生物医药技术（上海）有限公司 针对程序性死亡配体的结合物及其应用
CN109929037A (zh) * 2019-04-01 2019-06-25 华博生物医药技术（上海）有限公司 针对程序性死亡配体的结合物及其应用
CN110563849B (zh) * 2019-08-09 2022-09-09 安徽瀚海博兴生物技术有限公司 一种抗vegf-抗pd1双特异性抗体
CN110563849A (zh) * 2019-08-09 2019-12-13 安徽瀚海博兴生物技术有限公司 一种全新序列的抗vegf-抗pd1双特异性抗体
CN115803055A (zh) * 2020-06-11 2023-03-14 三生国健药业（上海）股份有限公司 一种抗pd-1单克隆抗体液体制剂
WO2021249551A1 (zh) * 2020-06-11 2021-12-16 三生国健药业（上海）股份有限公司 一种抗pd-1单克隆抗体液体制剂
CN114761434A (zh) * 2020-09-30 2022-07-15 苏州沙砾生物科技有限公司 Pd-1抗体及其制备方法与应用
CN114761434B (zh) * 2020-09-30 2023-06-27 苏州沙砾生物科技有限公司 Pd-1抗体及其制备方法与应用
WO2022068891A1 (zh) * 2020-09-30 2022-04-07 苏州沙砾生物科技有限公司 Pd-1抗体及其制备方法与应用
CN114316047A (zh) * 2021-01-14 2022-04-12 东大生物技术(苏州)有限公司 一组pd-1单克隆抗体及其医药用途
CN114316047B (zh) * 2021-01-14 2023-12-22 东大生物技术(苏州)有限公司 一组pd-1单克隆抗体及其医药用途
CN113150154B (zh) * 2021-04-15 2022-05-10 博奥信生物技术（南京）有限公司 抗人pdl1单克隆抗体及其用途
CN113150154A (zh) * 2021-04-15 2021-07-23 博奥信生物技术（南京）有限公司 抗人pdl1单克隆抗体及其用途
CN114539406A (zh) * 2021-12-31 2022-05-27 浙江大学 一种全人源抗PD-1的单克隆抗体No.8-3及其应用
CN114539407B (zh) * 2021-12-31 2023-04-18 浙江大学 一种全人源抗PD-1的单克隆抗体No.1-10及其应用
CN114539406B (zh) * 2021-12-31 2023-04-14 浙江大学 一种全人源抗PD-1的单克隆抗体No.8-3及其应用
CN114539407A (zh) * 2021-12-31 2022-05-27 浙江大学 一种全人源抗PD-1的单克隆抗体No.1-10及其应用
CN120078772A (zh) * 2025-03-11 2025-06-03 上海交通大学医学院附属仁济医院 A61603作为抗肝癌治疗药物的应用

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