ES3063402T3 - Stable, concentrated radionuclide complex solutions - Google Patents

Stable, concentrated radionuclide complex solutions

Info

Publication number
ES3063402T3
ES3063402T3 ES25162390T ES25162390T ES3063402T3 ES 3063402 T3 ES3063402 T3 ES 3063402T3 ES 25162390 T ES25162390 T ES 25162390T ES 25162390 T ES25162390 T ES 25162390T ES 3063402 T3 ES3063402 T3 ES 3063402T3
Authority
ES
Spain
Prior art keywords
complex solutions
stable
radionuclide complex
pharmaceutical product
concentrated
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
ES25162390T
Other languages
English (en)
Inventor
Daniela Chicco
Donato Barbato
Palo Francesco De
Lorenza Fugazza
Maurizio Mariani
Giovanni Tesoriere
Clementina Brambati
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Advanced Accelerator Applications SA
Original Assignee
Advanced Accelerator Applications SA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=63794577&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES3063402(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from PCT/IB2018/055575 external-priority patent/WO2020021310A1/en
Priority claimed from US16/045,484 external-priority patent/US20200030465A1/en
Application filed by Advanced Accelerator Applications SA filed Critical Advanced Accelerator Applications SA
Application granted granted Critical
Publication of ES3063402T3 publication Critical patent/ES3063402T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/02—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by the carrier, i.e. characterised by the agent or material covalently linked or complexing the radioactive nucleus
    • A61K51/04—Organic compounds
    • A61K51/0474—Organic compounds complexes or complex-forming compounds, i.e. wherein a radioactive metal (e.g. 111In3+) is complexed or chelated by, e.g. a N2S2, N3S, NS3, N4 chelating group
    • A61K51/0478—Organic compounds complexes or complex-forming compounds, i.e. wherein a radioactive metal (e.g. 111In3+) is complexed or chelated by, e.g. a N2S2, N3S, NS3, N4 chelating group complexes from non-cyclic ligands, e.g. EDTA, MAG3
    • A61K51/048—DTPA (diethylenetriamine tetraacetic acid)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/02—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by the carrier, i.e. characterised by the agent or material covalently linked or complexing the radioactive nucleus
    • A61K51/04—Organic compounds
    • A61K51/0474—Organic compounds complexes or complex-forming compounds, i.e. wherein a radioactive metal (e.g. 111In3+) is complexed or chelated by, e.g. a N2S2, N3S, NS3, N4 chelating group
    • A61K51/0482—Organic compounds complexes or complex-forming compounds, i.e. wherein a radioactive metal (e.g. 111In3+) is complexed or chelated by, e.g. a N2S2, N3S, NS3, N4 chelating group chelates from cyclic ligands, e.g. DOTA
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/02—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by the carrier, i.e. characterised by the agent or material covalently linked or complexing the radioactive nucleus
    • A61K51/04—Organic compounds
    • A61K51/08—Peptides, e.g. proteins, carriers being peptides, polyamino acids, proteins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/02—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by the carrier, i.e. characterised by the agent or material covalently linked or complexing the radioactive nucleus
    • A61K51/04—Organic compounds
    • A61K51/08—Peptides, e.g. proteins, carriers being peptides, polyamino acids, proteins
    • A61K51/083—Peptides, e.g. proteins, carriers being peptides, polyamino acids, proteins the peptide being octreotide or a somatostatin-receptor-binding peptide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/02—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by the carrier, i.e. characterised by the agent or material covalently linked or complexing the radioactive nucleus
    • A61K51/04—Organic compounds
    • A61K51/08—Peptides, e.g. proteins, carriers being peptides, polyamino acids, proteins
    • A61K51/088—Peptides, e.g. proteins, carriers being peptides, polyamino acids, proteins conjugates with carriers being peptides, polyamino acids or proteins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/12—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by a special physical form, e.g. emulsion, microcapsules, liposomes, characterized by a special physical form, e.g. emulsions, dispersions, microcapsules
    • A61K51/121—Solutions, i.e. homogeneous liquid formulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Optics & Photonics (AREA)
  • Physics & Mathematics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dispersion Chemistry (AREA)
  • Dermatology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)

Abstract

La presente invención se refiere a soluciones complejas de radionúclidos de alta concentración y elevada estabilidad química, que permiten su uso como producto farmacéutico con fines diagnósticos y/o terapéuticos. La estabilidad del producto farmacéutico se logra mediante al menos un estabilizador contra la degradación radiolítica. Se ha comprobado que el uso de dos estabilizadores introducidos durante el proceso de fabricación en diferentes etapas resulta particularmente ventajoso. (Traducción automática con Google Translate, sin valor legal)
ES25162390T 2018-07-25 2018-09-25 Stable, concentrated radionuclide complex solutions Active ES3063402T3 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PCT/IB2018/055575 WO2020021310A1 (en) 2018-07-25 2018-07-25 Stable, concentrated radionuclide complex solutions
US16/045,484 US20200030465A1 (en) 2018-07-25 2018-07-25 Stable, concentrated radionuclide complex solutions

Publications (1)

Publication Number Publication Date
ES3063402T3 true ES3063402T3 (en) 2026-04-16

Family

ID=63794577

Family Applications (5)

Application Number Title Priority Date Filing Date
ES18783136T Active ES3038413T3 (en) 2018-07-25 2018-09-25 Stable, concentrated radionuclide complex solutions
ES25162396T Active ES3065583T3 (en) 2018-07-25 2018-09-25 Stable, concentrated radionuclide complex solutions
ES25162390T Active ES3063402T3 (en) 2018-07-25 2018-09-25 Stable, concentrated radionuclide complex solutions
ES25162391T Active ES3064589T3 (en) 2018-07-25 2018-09-25 Stable, concentrated radionuclide complex solutions
ES25162394T Active ES3064434T3 (en) 2018-07-25 2018-09-25 Stable, concentrated radionuclide complex solutions

Family Applications Before (2)

Application Number Title Priority Date Filing Date
ES18783136T Active ES3038413T3 (en) 2018-07-25 2018-09-25 Stable, concentrated radionuclide complex solutions
ES25162396T Active ES3065583T3 (en) 2018-07-25 2018-09-25 Stable, concentrated radionuclide complex solutions

Family Applications After (2)

Application Number Title Priority Date Filing Date
ES25162391T Active ES3064589T3 (en) 2018-07-25 2018-09-25 Stable, concentrated radionuclide complex solutions
ES25162394T Active ES3064434T3 (en) 2018-07-25 2018-09-25 Stable, concentrated radionuclide complex solutions

Country Status (23)

Country Link
EP (7) EP4541380B1 (es)
JP (3) JP7402218B2 (es)
KR (4) KR102865113B1 (es)
CN (5) CN120860272A (es)
AU (6) AU2018433575B2 (es)
BR (1) BR112021001148A2 (es)
CA (1) CA3153630A1 (es)
CO (1) CO2021000506A2 (es)
DE (3) DE202018007007U1 (es)
DK (6) DK4545101T3 (es)
ES (5) ES3038413T3 (es)
FI (6) FI4541380T3 (es)
HR (6) HRP20260100T1 (es)
HU (1) HUE072720T2 (es)
IL (5) IL319541B2 (es)
LT (6) LT4545101T (es)
MX (2) MX2021000805A (es)
PL (6) PL3826686T3 (es)
PT (6) PT4541381T (es)
RS (6) RS67755B1 (es)
SG (1) SG11202100645XA (es)
SI (5) SI4545101T1 (es)
WO (1) WO2020021322A1 (es)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11541134B1 (en) 2021-08-02 2023-01-03 Rayzebio, Inc. Stabilized compositions of radionuclides and uses thereof
US20250032652A1 (en) * 2021-11-30 2025-01-30 Nihon Medi-Physics Co., Ltd. Stabilized radiopharmaceutical composition
CN118159303A (zh) * 2022-02-04 2024-06-07 先进加速器应用公司 用于大规模合成放射性核素络合物的方法
CN114404618A (zh) * 2022-03-28 2022-04-29 北京先通国际医药科技股份有限公司 放射性药物水溶液及其用途
CN114404619A (zh) * 2022-03-28 2022-04-29 北京先通国际医药科技股份有限公司 放射性药物水溶液及其制备方法和用途
CN116920129A (zh) * 2022-04-02 2023-10-24 北京先通国际医药科技股份有限公司 放射性药物水溶液及其制备方法和用途
US20260102526A1 (en) * 2024-06-27 2026-04-16 Curium Us Llc 177lutetium-dota-tate formulations

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US2779780A (en) 1955-03-01 1957-01-29 Du Pont 1, 4-diamino-2, 3-dicyano-1, 4-bis (substituted mercapto) butadienes and their preparation
US4261989A (en) 1979-02-19 1981-04-14 Kaken Chemical Co. Ltd. Geldanamycin derivatives and antitumor drug
EP0647450A1 (en) 1993-09-09 1995-04-12 BEHRINGWERKE Aktiengesellschaft Improved prodrugs for enzyme mediated activation
US6066309A (en) * 1996-02-02 2000-05-23 Rhomed Incorporated Post-labeling stabilization of radiolabeled proteins and peptides
IL143236A0 (en) 1998-12-16 2002-04-21 Warner Lambert Co Treatment of arthritis with mek inhibitors
WO2002006213A2 (en) 2000-07-19 2002-01-24 Warner-Lambert Company Oxygenated esters of 4-iodo phenylamino benzhydroxamic acids
US6995162B2 (en) 2001-01-12 2006-02-07 Amgen Inc. Substituted alkylamine derivatives and methods of use
BR0307544A (pt) 2002-02-01 2004-12-07 Ariad Gene Therapeutics Inc Compostos contendo fósforos, componentes e composição bem como, sua utilização através de métodos de tratamentos
US7799827B2 (en) 2002-03-08 2010-09-21 Eisai Co., Ltd. Macrocyclic compounds useful as pharmaceuticals
TWI343377B (en) 2002-03-13 2011-06-11 Array Biopharma Inc N3 alkylated benzimidazole derivatives as mek inhibitors
TWI275390B (en) 2002-04-30 2007-03-11 Wyeth Corp Process for the preparation of 7-substituted-3- quinolinecarbonitriles
SG177216A1 (en) * 2003-07-24 2012-01-30 Bracco Imaging Spa Stable radiopharmaceutical compositions and methods for their preparation
WO2007014011A2 (en) 2005-07-21 2007-02-01 Ardea Biosciences, Inc. N-(arylamino)-sulfonamide inhibitors of mek
WO2008009444A1 (en) 2006-07-19 2008-01-24 Van Dulmen, Adrianus, A. Use of ethanol for stabilizing a single-vial liquid formulation of a radiolabeled peptide
CA3042737A1 (en) * 2016-11-04 2018-05-11 Clarity Pharmaceuticals Pty Ltd Formulations for radiotherapy and diagnostic imaging
US10596276B2 (en) 2018-07-25 2020-03-24 Advanced Accelerator Applications (Italy) S.R.L. Stable, concentrated radionuclide complex solutions

Also Published As

Publication number Publication date
LT3826686T (lt) 2025-08-25
IL313560B2 (en) 2025-11-01
AU2025220852A1 (en) 2025-09-11
SG11202100645XA (en) 2021-02-25
EP4541381B1 (en) 2026-02-04
EP4541379A3 (en) 2025-07-23
JP2025111424A (ja) 2025-07-30
LT4541379T (lt) 2026-02-10
AU2025204901A1 (en) 2025-07-17
DK3826686T3 (da) 2025-08-25
AU2022203683A1 (en) 2022-06-16
HRP20260338T1 (hr) 2026-04-10
MX2021000805A (es) 2021-05-12
AU2024201217B2 (en) 2025-02-27
EP4640241A2 (en) 2025-10-29
WO2020021322A1 (en) 2020-01-30
AU2025202231A1 (en) 2025-04-17
LT4541381T (lt) 2026-03-25
SI4545101T1 (sl) 2026-04-30
PL4541380T3 (pl) 2026-03-30
FI4541379T3 (fi) 2026-02-17
FI3826686T3 (fi) 2025-08-20
LT4545100T (lt) 2026-02-25
PT4541379T (pt) 2026-01-29
KR20250017751A (ko) 2025-02-04
FI4541380T3 (fi) 2026-03-02
CN112584875A (zh) 2021-03-30
IL319542A (en) 2025-05-01
IL326944A (en) 2026-05-01
AU2022203683B2 (en) 2023-12-21
EP4640241A3 (en) 2025-12-10
ES3038413T3 (en) 2025-10-13
DK4541381T3 (da) 2026-04-07
CN121081692A (zh) 2025-12-09
CN120860270A (zh) 2025-10-31
KR102643582B1 (ko) 2024-03-05
JP7796696B2 (ja) 2026-01-09
EP4541380A3 (en) 2025-07-23
HRP20250912T1 (hr) 2025-09-26
FI4541381T3 (fi) 2026-04-01
PL4541379T3 (pl) 2026-03-23
KR20240033296A (ko) 2024-03-12
PT4541381T (pt) 2026-03-17
EP4541381A2 (en) 2025-04-23
EP4541379B1 (en) 2025-11-19
PL3826686T3 (pl) 2025-09-22
IL319541B2 (en) 2026-01-01
PL4541381T3 (pl) 2026-05-11
PT4545101T (pt) 2026-02-24
DE202018006567U1 (de) 2021-04-01
AU2025202231B2 (en) 2026-05-14
DE202018007006U1 (de) 2025-11-13
PL4545101T3 (pl) 2026-03-30
IL313560A (en) 2024-08-01
AU2025220852B2 (en) 2025-10-23
DK4545101T3 (da) 2026-03-02
CO2021000506A2 (es) 2021-04-19
RS67864B1 (sr) 2026-04-30
PT4541380T (pt) 2026-02-24
SI4545100T1 (sl) 2026-03-31
PL4545100T3 (pl) 2026-03-30
AU2024201217A1 (en) 2024-03-14
SI3826686T1 (sl) 2025-09-30
PT3826686T (pt) 2025-08-04
LT4545101T (lt) 2026-03-10
HUE072720T2 (hu) 2025-12-28
EP4545101A2 (en) 2025-04-30
CN120860271A (zh) 2025-10-31
KR20260030955A (ko) 2026-03-06
RS67034B1 (sr) 2025-08-29
BR112021001148A2 (pt) 2021-04-20
JP7402218B2 (ja) 2023-12-20
AU2018433575B2 (en) 2022-07-07
AU2018433575A1 (en) 2021-02-11
IL319541B1 (en) 2025-09-01
SI4541380T1 (sl) 2026-04-30
HRP20260179T1 (hr) 2026-04-10
RS67754B1 (sr) 2026-03-31
IL313560B1 (en) 2025-07-01
FI4545101T3 (fi) 2026-02-24
EP4545101A3 (en) 2025-07-23
DK4545100T3 (da) 2026-02-23
DE202018007007U1 (de) 2025-11-13
JP2023117417A (ja) 2023-08-23
EP4541380B1 (en) 2025-12-10
EP4541381A3 (en) 2025-07-23
PT4545100T (pt) 2026-02-16
EP3826686B1 (en) 2025-05-21
HRP20260222T1 (hr) 2026-03-27
HRP20260100T1 (hr) 2026-04-10
ES3064589T3 (en) 2026-04-27
CN120860272A (zh) 2025-10-31
IL280314A (en) 2021-03-25
RS67667B1 (sr) 2026-02-27
IL319541A (en) 2025-05-01
RS67755B1 (sr) 2026-03-31
IL319542B1 (en) 2026-04-01
ES3064434T3 (en) 2026-04-24
AU2025204901B2 (en) 2025-09-18
EP4545100A2 (en) 2025-04-30
DK4541379T3 (da) 2026-02-02
SI4541379T1 (sl) 2026-03-31
FI4545100T3 (fi) 2026-03-02
EP4541379A2 (en) 2025-04-23
EP4545100B1 (en) 2025-12-10
MX2025012060A (es) 2025-11-03
LT4541380T (lt) 2026-03-10
CA3153630A1 (en) 2020-01-30
KR102932818B1 (ko) 2026-03-03
DK4541380T3 (da) 2026-02-23
HRP20260237T1 (hr) 2026-04-10
ES3065583T3 (en) 2026-05-06
EP3826686A1 (en) 2021-06-02
EP4545100A3 (en) 2025-07-23
EP4541380A2 (en) 2025-04-23
JP2022501313A (ja) 2022-01-06
RS67729B1 (sr) 2026-03-31
EP4545101B1 (en) 2025-12-10
KR20210035855A (ko) 2021-04-01
KR102865113B1 (ko) 2025-09-26

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