DK3381469T3 - Anti-erbb2 antistoflægemiddelskonjugat og sammensætning deraf, fremgangsmåde til fremstilling deraf og anvendelse deraf - Google Patents
Anti-erbb2 antistoflægemiddelskonjugat og sammensætning deraf, fremgangsmåde til fremstilling deraf og anvendelse deraf Download PDFInfo
- Publication number
- DK3381469T3 DK3381469T3 DK16867957.9T DK16867957T DK3381469T3 DK 3381469 T3 DK3381469 T3 DK 3381469T3 DK 16867957 T DK16867957 T DK 16867957T DK 3381469 T3 DK3381469 T3 DK 3381469T3
- Authority
- DK
- Denmark
- Prior art keywords
- conjugate
- manufacture
- composition
- erbb2 antibody
- antibody medicines
- Prior art date
Links
- 239000003814 drug Substances 0.000 title 1
- 238000004519 manufacturing process Methods 0.000 title 1
- 238000000034 method Methods 0.000 title 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/536—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines ortho- or peri-condensed with carbocyclic ring systems
-
- 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
- A61K39/02—Bacterial antigens
- A61K39/07—Bacillus
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- 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
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- 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
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/62—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 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 a protein, peptide or polyamino acid
- A61K47/64—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
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- A—HUMAN NECESSITIES
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- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/62—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 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 a protein, peptide or polyamino acid
- A61K47/65—Peptidic linkers, binders or spacers, e.g. peptidic enzyme-labile linkers
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- A—HUMAN NECESSITIES
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- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/68—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 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
- A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
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- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/68—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 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
- A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
- A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
- A61K47/68031—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being an auristatin
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- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/68—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 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
- A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
- A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
- A61K47/68033—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a maytansine
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- A—HUMAN NECESSITIES
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- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/68—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 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
- A61K47/6835—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 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
- A61K47/6851—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 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
- A61K47/6869—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 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 a cell of the reproductive system: ovaria, uterus, testes, prostate
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- 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
- C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
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- 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
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Oncology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Cell Biology (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Reproductive Health (AREA)
- Biomedical Technology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201510824064.8A CN106729743B (zh) | 2015-11-23 | 2015-11-23 | 抗ErbB2抗体-药物偶联物及其组合物、制备方法和应用 |
PCT/CN2016/106802 WO2017088734A1 (zh) | 2015-11-23 | 2016-11-22 | 抗ErbB2抗体-药物偶联物及其组合物、制备方法和应用 |
Publications (1)
Publication Number | Publication Date |
---|---|
DK3381469T3 true DK3381469T3 (da) | 2021-08-09 |
Family
ID=58762994
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK16867957.9T DK3381469T3 (da) | 2015-11-23 | 2016-11-22 | Anti-erbb2 antistoflægemiddelskonjugat og sammensætning deraf, fremgangsmåde til fremstilling deraf og anvendelse deraf |
Country Status (15)
Country | Link |
---|---|
US (3) | US20190076438A1 (da) |
EP (1) | EP3381469B1 (da) |
JP (2) | JP6888871B2 (da) |
KR (1) | KR20180080128A (da) |
CN (4) | CN106729743B (da) |
AU (1) | AU2016359514A1 (da) |
CA (1) | CA3000763A1 (da) |
DK (1) | DK3381469T3 (da) |
EA (1) | EA039757B1 (da) |
ES (1) | ES2887349T3 (da) |
HK (1) | HK1243957B (da) |
HU (1) | HUE055671T2 (da) |
PL (1) | PL3381469T3 (da) |
PT (1) | PT3381469T (da) |
WO (1) | WO2017088734A1 (da) |
Families Citing this family (14)
Publication number | Priority date | Publication date | Assignee | Title |
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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 |
CN107857798B (zh) * | 2016-09-22 | 2021-03-23 | 联宁(苏州)生物制药有限公司 | 一种用于抗体药物偶联物的毒素及其制备方法 |
CN107915770B (zh) * | 2016-10-11 | 2020-08-25 | 联宁(苏州)生物制药有限公司 | 一种抗体药物偶联物中间体及其制备方法 |
US20210330801A1 (en) * | 2017-03-02 | 2021-10-28 | Cadila Healthcare Limited | Novel protein drug conjugate formulation |
CN110312730B (zh) | 2017-04-19 | 2024-06-18 | 四川科伦博泰生物医药股份有限公司 | 细胞毒素和偶联物、其用途和制备方法 |
CN113698414A (zh) | 2017-12-15 | 2021-11-26 | 四川科伦博泰生物医药股份有限公司 | 生物活性物偶联物及其制备方法和用途 |
CN111447939B (zh) * | 2018-01-30 | 2024-07-12 | 四川科伦博泰生物医药股份有限公司 | 制备偶联物的方法 |
US20210000970A1 (en) * | 2018-05-11 | 2021-01-07 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Use of Anti-HER2 Antibody-Drug Conjugate in Cancer Treatment |
CN109692331A (zh) * | 2019-01-07 | 2019-04-30 | 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 |
JP7264986B2 (ja) * | 2019-03-26 | 2023-04-25 | レメゲン シーオー.,エルティーディー. | 抗Her2抗体薬物コンジュゲートの製剤 |
US11958910B2 (en) | 2020-02-28 | 2024-04-16 | Regeneron Pharmaceuticals, Inc. | Bispecific antigen binding molecules that bind HER2, and methods of use thereof |
CN116234564A (zh) * | 2020-09-16 | 2023-06-06 | 四川科伦博泰生物医药股份有限公司 | 抗Nectin-4抗体、包含所述抗体的缀合物及其应用 |
WO2022233262A1 (zh) * | 2021-05-07 | 2022-11-10 | 四川科伦博泰生物医药股份有限公司 | 抗体药物偶联物治疗癌症的方法及用途 |
CN113521018B (zh) * | 2021-07-20 | 2022-11-18 | 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 |
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2015
- 2015-11-23 CN CN201510824064.8A patent/CN106729743B/zh active Active
-
2016
- 2016-11-22 DK DK16867957.9T patent/DK3381469T3/da active
- 2016-11-22 CN CN201811298547.9A patent/CN109395089B/zh active Active
- 2016-11-22 ES ES16867957T patent/ES2887349T3/es active Active
- 2016-11-22 US US15/765,685 patent/US20190076438A1/en active Pending
- 2016-11-22 HU HUE16867957A patent/HUE055671T2/hu unknown
- 2016-11-22 CN CN201680036760.5A patent/CN107921124B/zh active Active
- 2016-11-22 CN CN201811298611.3A patent/CN109395090B/zh active Active
- 2016-11-22 EP EP16867957.9A patent/EP3381469B1/en active Active
- 2016-11-22 EA EA201792590A patent/EA039757B1/ru unknown
- 2016-11-22 PT PT168679579T patent/PT3381469T/pt unknown
- 2016-11-22 JP JP2017566133A patent/JP6888871B2/ja active Active
- 2016-11-22 CA CA3000763A patent/CA3000763A1/en active Pending
- 2016-11-22 AU AU2016359514A patent/AU2016359514A1/en not_active Abandoned
- 2016-11-22 WO PCT/CN2016/106802 patent/WO2017088734A1/zh active Application Filing
- 2016-11-22 KR KR1020177036761A patent/KR20180080128A/ko not_active Application Discontinuation
- 2016-11-22 PL PL16867957T patent/PL3381469T3/pl unknown
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2018
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Also Published As
Publication number | Publication date |
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US20210252006A1 (en) | 2021-08-19 |
CA3000763A1 (en) | 2017-06-01 |
KR20180080128A (ko) | 2018-07-11 |
CN109395090B (zh) | 2022-03-25 |
CN109395089A (zh) | 2019-03-01 |
EP3381469A1 (en) | 2018-10-03 |
JP7200454B2 (ja) | 2023-01-10 |
AU2016359514A1 (en) | 2018-04-26 |
CN106729743A (zh) | 2017-05-31 |
JP2019502650A (ja) | 2019-01-31 |
CN109395090A (zh) | 2019-03-01 |
CN107921124A (zh) | 2018-04-17 |
HUE055671T2 (hu) | 2021-12-28 |
US11903948B2 (en) | 2024-02-20 |
US20230293536A1 (en) | 2023-09-21 |
CN107921124B (zh) | 2018-12-28 |
JP2021152006A (ja) | 2021-09-30 |
EP3381469A4 (en) | 2019-07-31 |
CN109395089B (zh) | 2022-08-12 |
PT3381469T (pt) | 2021-09-02 |
JP6888871B2 (ja) | 2021-06-16 |
WO2017088734A1 (zh) | 2017-06-01 |
EA201792590A1 (ru) | 2019-03-29 |
EA039757B1 (ru) | 2022-03-10 |
PL3381469T3 (pl) | 2021-11-29 |
CN106729743B (zh) | 2021-09-21 |
EP3381469B1 (en) | 2021-06-30 |
US20190076438A1 (en) | 2019-03-14 |
ES2887349T3 (es) | 2021-12-22 |
HK1243957B (zh) | 2019-10-04 |
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