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DK3480215T5 - Anti-her2-antistof og konjugat deraf - Google Patents

Anti-her2-antistof og konjugat deraf Download PDF

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Publication number
DK3480215T5
DK3480215T5 DK18204950.2T DK18204950T DK3480215T5 DK 3480215 T5 DK3480215 T5 DK 3480215T5 DK 18204950 T DK18204950 T DK 18204950T DK 3480215 T5 DK3480215 T5 DK 3480215T5
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Denmark
Prior art keywords
conjugate
her2 antibody
her2
antibody
Prior art date
Application number
DK18204950.2T
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English (en)
Other versions
DK3480215T3 (da
Inventor
Jianmin Fang
Changjiang Huang
Jing Jiang
Xuejing Yao
Hongwen Li
Qiaoyu Xu
Zhuanglin Li
Original Assignee
Remegen Co Ltd
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Publication of DK3480215T3 publication Critical patent/DK3480215T3/da
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Publication of DK3480215T5 publication Critical patent/DK3480215T5/da

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    • 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
    • C07K16/2896Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
    • 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
    • C07K16/32Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • 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
    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • 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
    • A61K47/50Medicinal 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
    • 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
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/68Medicinal 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
    • A61K47/6801Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • 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
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/68Medicinal 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
    • 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
    • A61K47/6805Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a vinca alkaloid
    • 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
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/68Medicinal 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
    • 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
    • A61K47/6851Medicinal 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
    • A61K47/6855Medicinal 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 the tumour determinant being from breast cancer cell
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/63Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • 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
    • C07K2317/90Immunoglobulins 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)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Genetics & Genomics (AREA)
  • Cell Biology (AREA)
  • Oncology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Microbiology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Plant Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
DK18204950.2T 2013-11-19 2014-11-18 Anti-her2-antistof og konjugat deraf DK3480215T5 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201310586326 2013-11-19
EP14864053.5A EP3072907B1 (en) 2013-11-19 2014-11-18 Anti-her2 antibody and conjugate thereof

Publications (2)

Publication Number Publication Date
DK3480215T3 DK3480215T3 (da) 2021-07-05
DK3480215T5 true DK3480215T5 (da) 2021-08-16

Family

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Family Applications (2)

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DK18204950.2T DK3480215T5 (da) 2013-11-19 2014-11-18 Anti-her2-antistof og konjugat deraf
DK14864053.5T DK3072907T3 (da) 2013-11-19 2014-11-18 Anti-her2- antistof og konjugat deraf

Family Applications After (1)

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DK14864053.5T DK3072907T3 (da) 2013-11-19 2014-11-18 Anti-her2- antistof og konjugat deraf

Country Status (20)

Country Link
US (1) US10087260B2 (da)
EP (2) EP3072907B1 (da)
JP (2) JP6326137B2 (da)
KR (3) KR101993136B1 (da)
CN (3) CN109320612B (da)
AU (1) AU2014352475B2 (da)
CA (1) CA2919359C (da)
CY (1) CY1124651T1 (da)
DK (2) DK3480215T5 (da)
ES (1) ES2879799T3 (da)
HR (1) HRP20211023T1 (da)
HU (1) HUE055269T2 (da)
LT (1) LT3480215T (da)
PL (1) PL3480215T3 (da)
PT (1) PT3480215T (da)
RS (1) RS62157B1 (da)
RU (1) RU2656161C1 (da)
SI (1) SI3480215T1 (da)
SM (1) SMT202100394T1 (da)
WO (1) WO2015074528A1 (da)

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KR102710423B1 (ko) * 2018-08-29 2024-09-25 레메젠 코, 리미티드 요로상피 암종의 치료에서 항―her2 항체―약물 접합체의 용도
JP2022512057A (ja) 2018-12-17 2022-02-02 栄昌生物制薬(烟台)股▲分▼有限公司 抗体薬物複合体のためのリンカーおよびその使用
CN109498816A (zh) * 2019-01-07 2019-03-22 合肥瀚科迈博生物技术有限公司 一种抗体偶联药物的制备方法
WO2020177570A1 (zh) * 2019-03-01 2020-09-10 荣昌生物制药(烟台)股份有限公司 一种Her2伴随诊断免疫组化检测抗体及其应用
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CN114736300B (zh) * 2022-06-09 2022-08-19 苏州百道医疗科技有限公司 一种抗her2重组兔单克隆抗体及其应用
TW202502352A (zh) * 2023-03-10 2025-01-16 美商思進公司 使用抗her2抗體-藥物結合物及her2激酶抑制劑治療癌症之方法
CN118725124B (zh) * 2023-03-29 2025-09-16 东莞市朋志生物科技有限公司 抗胃蛋白酶原ⅱ抗体、检测胃蛋白酶原ⅱ的试剂和试剂盒
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Publication number Publication date
CN110240655A (zh) 2019-09-17
KR20190002716A (ko) 2019-01-08
JP6326137B2 (ja) 2018-05-16
BR112016002752A2 (pt) 2017-11-21
EP3480215A1 (en) 2019-05-08
EP3480215B1 (en) 2021-06-23
SI3480215T1 (sl) 2021-12-31
JP2018138034A (ja) 2018-09-06
EP3072907B1 (en) 2019-02-20
JP2016528902A (ja) 2016-09-23
ES2879799T3 (es) 2021-11-23
CA2919359A1 (en) 2015-05-28
EP3480215B8 (en) 2021-07-28
AU2014352475A1 (en) 2016-02-18
DK3072907T3 (da) 2019-04-01
RS62157B1 (sr) 2021-08-31
AU2014352475B2 (en) 2017-08-17
CA2919359C (en) 2019-01-15
KR101854443B1 (ko) 2018-06-15
CN110240655B (zh) 2023-05-16
BR112016002752A8 (pt) 2023-02-28
SMT202100394T1 (it) 2021-09-14
KR101936697B1 (ko) 2019-01-10
LT3480215T (lt) 2021-08-25
CN105008398B (zh) 2018-10-16
HUE055269T2 (hu) 2021-11-29
US20160304621A1 (en) 2016-10-20
RU2016106339A (ru) 2017-12-25
CY1124651T1 (el) 2022-07-22
PL3480215T3 (pl) 2021-12-13
RU2656161C1 (ru) 2018-05-31
PT3480215T (pt) 2021-07-05
JP6728264B2 (ja) 2020-07-22
DK3480215T3 (da) 2021-07-05
WO2015074528A1 (zh) 2015-05-28
KR101993136B1 (ko) 2019-06-26
CN109320612B (zh) 2020-10-27
EP3072907A1 (en) 2016-09-28
EP3072907A4 (en) 2017-06-14
KR20180050423A (ko) 2018-05-14
KR20160065972A (ko) 2016-06-09
HRP20211023T1 (hr) 2021-09-17
CN105008398A (zh) 2015-10-28
CN109320612A (zh) 2019-02-12
US10087260B2 (en) 2018-10-02

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