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DK3050576T3 - Pegylerede rekombinante forbindelser af humant væksthormon - Google Patents

Pegylerede rekombinante forbindelser af humant væksthormon Download PDF

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Publication number
DK3050576T3
DK3050576T3 DK16156852.2T DK16156852T DK3050576T3 DK 3050576 T3 DK3050576 T3 DK 3050576T3 DK 16156852 T DK16156852 T DK 16156852T DK 3050576 T3 DK3050576 T3 DK 3050576T3
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DK
Denmark
Prior art keywords
growth hormone
human growth
pegylated recombinant
recombinant compounds
compounds
Prior art date
Application number
DK16156852.2T
Other languages
English (en)
Inventor
Harald Rau
Susanne Kindermann
Torben Lessmann
Ulrich Hersel
Thomas Wegge
Grethe Nørskov Rasmussen
Kennett Sprogøe
Original Assignee
Ascendis Pharma Endocrinology Div A/S
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
Priority claimed from EP08155408A external-priority patent/EP2113256A1/en
Application filed by Ascendis Pharma Endocrinology Div A/S filed Critical Ascendis Pharma Endocrinology Div A/S
Application granted granted Critical
Publication of DK3050576T3 publication Critical patent/DK3050576T3/da

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/27—Growth hormone [GH], i.e. somatotropin
    • 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
    • A61K47/50—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
    • A61K47/56—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • 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
    • A61K47/50—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
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    • A61P19/00—Drugs for skeletal disorders
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    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • 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
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/18—Antivirals for RNA viruses for HIV
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A61P39/06—Free radical scavengers or antioxidants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/10—Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/61—Growth hormone [GH], i.e. somatotropin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Endocrinology (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Zoology (AREA)
  • Diabetes (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Toxicology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Reproductive Health (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Virology (AREA)
  • Hematology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Obesity (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
DK16156852.2T 2008-04-29 2009-04-29 Pegylerede rekombinante forbindelser af humant væksthormon DK3050576T3 (da)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP08155408A EP2113256A1 (en) 2008-04-29 2008-04-29 PEGylated rhGH compounds
EP08162865 2008-08-22
EP08167289 2008-10-22
EP09738181.8A EP2279007B1 (en) 2008-04-29 2009-04-29 Pegylated recombinant human growth hormone compounds

Publications (1)

Publication Number Publication Date
DK3050576T3 true DK3050576T3 (da) 2021-06-07

Family

ID=40872078

Family Applications (2)

Application Number Title Priority Date Filing Date
DK16156852.2T DK3050576T3 (da) 2008-04-29 2009-04-29 Pegylerede rekombinante forbindelser af humant væksthormon
DK09738181.8T DK2279007T3 (da) 2008-04-29 2009-04-29 Pegylerede rekombinante forbindelser af humant væksthormon

Family Applications After (1)

Application Number Title Priority Date Filing Date
DK09738181.8T DK2279007T3 (da) 2008-04-29 2009-04-29 Pegylerede rekombinante forbindelser af humant væksthormon

Country Status (19)

Country Link
US (4) US9272048B2 (da)
EP (3) EP2279007B1 (da)
JP (5) JP6112766B2 (da)
CN (2) CN102014965B (da)
BR (1) BRPI0911780B1 (da)
CA (3) CA3004716C (da)
CY (2) CY1117882T1 (da)
DK (2) DK3050576T3 (da)
ES (2) ES2587400T3 (da)
HR (2) HRP20161040T1 (da)
HU (2) HUE054585T2 (da)
IL (2) IL208833A (da)
LT (2) LT2279007T (da)
MX (3) MX2010011800A (da)
PL (2) PL2279007T3 (da)
PT (2) PT3050576T (da)
RU (1) RU2689336C2 (da)
SI (2) SI2279007T1 (da)
WO (1) WO2009133137A2 (da)

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SG181648A1 (en) * 2009-12-15 2012-07-30 Ascendis Pharma As Dry growth hormone composition transiently linked to a polymer carrier
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EP2525831B1 (en) 2010-01-22 2019-05-15 Ascendis Pharma A/S Carrier-linked carbamate prodrug linkers
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AU2011277983C1 (en) * 2010-07-16 2016-09-29 Ablynx Nv Modified single domain antigen binding molecules and uses thereof
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KR101365849B1 (ko) * 2012-03-28 2014-02-24 경동제약 주식회사 솔리페나신 또는 그의 염의 제조방법 및 이에 사용되는 신규 중간체
HK1205697A1 (zh) 2012-04-25 2015-12-24 Ascendis Pharma A/S 含有羟基的药物的前药
WO2014056915A1 (en) 2012-10-11 2014-04-17 Ascendis Pharma A/S Diagnosis, prevention and treatment of diseases of the joint
HK1214151A1 (zh) 2012-12-07 2016-07-22 Ascendis Pharma A/S 载体连接型前列腺素类前药
CN103976982A (zh) * 2014-06-03 2014-08-13 长春理工大学 一种包载重组人生长激素缓释药物微囊
KR20250059541A (ko) 2014-11-18 2025-05-02 아센디스 파마 엔도크리놀로지 디비전 에이/에스 신규한 중합체성 hGH 프로드러그
PT3220892T (pt) 2014-11-21 2021-11-05 Ascendis Pharma Endocrinology Div A/S Formas de dosagem de hormona do crescimento de longa ação
AR105319A1 (es) 2015-06-05 2017-09-27 Sanofi Sa Profármacos que comprenden un conjugado agonista dual de glp-1 / glucagón conector ácido hialurónico
BR112018017091A2 (pt) 2016-03-01 2019-01-02 Ascendis Pharma Bone Diseases As profármacos de pth
CN109789189B (zh) 2016-09-29 2024-01-23 阿森迪斯药物骨疾病股份有限公司 控释pth化合物的剂量方案
ES3012647T3 (en) * 2016-09-29 2025-04-09 Ascendis Pharma Bone Diseases As Controlled-release pth compounds
NZ751745A (en) 2016-09-29 2023-05-26 Ascendis Pharma Bone Diseases As Pth compounds with low peak-to-trough ratios
TW201832783A (zh) 2016-12-02 2018-09-16 法商賽諾菲公司 包含ｇｌｐ－１／胰高血糖素雙重激動劑、連接子和透明質酸的接合物
MA52662A (fr) * 2018-03-28 2021-02-17 Ascendis Pharma Oncology Div A/S Conjugués d'il-2
TW202015735A (zh) 2018-05-30 2020-05-01 法商賽諾菲公司 包含ｇｌｐ－１／升糖素／ｇｉｐ三重受體促效劑、連接子及透明質酸之接合物
KR102891411B1 (ko) 2019-02-11 2025-11-25 아센디스 파마 본 디지즈 에이/에스 Pth 접합체의 액체 약학 제제
JP7524206B2 (ja) 2019-03-04 2024-07-29 アセンディス ファーマ エンドクライノロジー ディヴィジョン エー／エス １日ごとのソマトロピンよりも優れた効力を有する長時間作用性成長ホルモン剤形
IL298642A (en) 2020-06-03 2023-01-01 Ascendis Pharma Oncology Div A/S il-2 sequences and uses thereof
JP2023540701A (ja) 2020-08-28 2023-09-26 アセンディス ファーマ オンコロジー ディヴィジョン エー／エス グリコシル化ｉｌ－２タンパク質及びその使用
CN112362643A (zh) * 2020-11-09 2021-02-12 长春金赛药业有限责任公司 一种基于镧系元素化学发光法长效生长激素免疫定量检测试剂盒及其方法
CN114539384B (zh) * 2020-11-19 2024-09-06 江苏众红生物工程创药研究院有限公司 聚乙二醇化长效生长激素及其制备方法和医药应用
JP2023160780A (ja) 2022-04-22 2023-11-02 日油株式会社 アセタール型リリーサブルポリオキシエチレン誘導体、その製造方法及びアセタール型リリーサブルポリオキシエチレン結合体
KR20250131829A (ko) 2023-03-06 2025-09-03 아센디스 파마 에이에스 알부민 결합 모이어티를 포함하는 약물 화합물
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