CA3137539A1 - Clotting factor preparations for delivery into tissue of the intestinal tract using a swallowable drug delivery device - Google Patents

Clotting factor preparations for delivery into tissue of the intestinal tract using a swallowable drug delivery device Download PDF

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Publication number
CA3137539A1
CA3137539A1 CA3137539A CA3137539A CA3137539A1 CA 3137539 A1 CA3137539 A1 CA 3137539A1 CA 3137539 A CA3137539 A CA 3137539A CA 3137539 A CA3137539 A CA 3137539A CA 3137539 A1 CA3137539 A1 CA 3137539A1
Authority
CA
Canada
Prior art keywords
factor
capsule
delivery
clotting
fviii
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.)
Pending
Application number
CA3137539A
Other languages
English (en)
French (fr)
Inventor
Mir A. Imran
Sara Ansaloni
Radhika KORUPOLU
Joel Harris
Mir Hashim
Anusha GARAPATY
Anvesh DASARI
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.)
Rani Therapeutics LLC
Original Assignee
Rani Therapeutics LLC
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
Application filed by Rani Therapeutics LLC filed Critical Rani Therapeutics LLC
Publication of CA3137539A1 publication Critical patent/CA3137539A1/en
Pending legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • A61K38/37Factors VIII
    • 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
    • A61K47/56Medicinal 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
    • A61K47/59Medicinal 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
    • A61K47/60Medicinal 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
    • 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
    • A61K47/6811Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14276Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565Administration mechanisms, i.e. constructional features, modes of administering a dose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3295Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14276Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
    • A61M2005/14284Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation with needle insertion means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0023Drug applicators using microneedles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • A61M2205/3507Communication with implanted devices, e.g. external control
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • A61M2205/6063Optical identification systems
    • A61M2205/6072Bar codes

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Immunology (AREA)
  • Vascular Medicine (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Dermatology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
CA3137539A 2019-05-03 2020-05-01 Clotting factor preparations for delivery into tissue of the intestinal tract using a swallowable drug delivery device Pending CA3137539A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201962843221P 2019-05-03 2019-05-03
US62/843,221 2019-05-03
US201962845209P 2019-05-08 2019-05-08
US62/845,209 2019-05-08
PCT/US2020/031197 WO2020227162A1 (en) 2019-05-03 2020-05-01 Clotting factor preparations for delivery into tissue of the intestinal tract using a swallowable drug delivery device

Publications (1)

Publication Number Publication Date
CA3137539A1 true CA3137539A1 (en) 2020-10-20

Family

ID=73050863

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3137539A Pending CA3137539A1 (en) 2019-05-03 2020-05-01 Clotting factor preparations for delivery into tissue of the intestinal tract using a swallowable drug delivery device

Country Status (10)

Country Link
US (1) US20220118056A1 (https=)
EP (1) EP3962516B1 (https=)
JP (1) JP7692363B2 (https=)
KR (1) KR20220004148A (https=)
CN (1) CN114007638A (https=)
AU (1) AU2020270420B2 (https=)
BR (1) BR112021021904A2 (https=)
CA (1) CA3137539A1 (https=)
MX (1) MX2021013310A (https=)
WO (1) WO2020227162A1 (https=)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022218962A1 (en) * 2021-04-13 2022-10-20 Grifols Worldwide Operations Limited Liquid composition comprising factor viii or factor viii/von willebrand factor complex

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8759284B2 (en) 2009-12-24 2014-06-24 Rani Therapeutics, Llc Therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US9415004B2 (en) 2010-12-23 2016-08-16 Rani Therapeutics, Llc Therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US9402806B2 (en) 2010-12-23 2016-08-02 Rani Therapeutics, Llc Therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US9259386B2 (en) 2010-12-23 2016-02-16 Rani Therapeutics, Llc Therapeutic preparation comprising somatostatin or somatostatin analogoue for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US8809269B2 (en) 2010-12-23 2014-08-19 Rani Therapeutics, Llc Therapeutic agent preparations comprising insulin for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US8734429B2 (en) 2010-12-23 2014-05-27 Rani Therapeutics, Llc Device, system and methods for the oral delivery of therapeutic compounds
US10689460B2 (en) 2014-05-15 2020-06-23 Incube Labs, Llc PCSK9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
JP7370974B2 (ja) 2017-11-07 2023-10-30 ラニ セラピューティクス, エルエルシー 嚥下可能薬物送達デバイスを使用する腸管組織への送達のための凝固因子調製物
BR112021017993A2 (pt) * 2019-03-13 2022-01-18 Rani Therapeutics Llc Preparações de agente terapêutico e métodos para liberação de fármacos em um lúmen do trato intestinal com o uso de um dispositivo ingerível de liberação de fármacos
KR20230154034A (ko) * 2021-02-24 2023-11-07 라니 테라퓨틱스, 엘엘씨 A형 혈우병의 치료
CN115300774B (zh) * 2022-08-27 2024-01-30 深圳市资福医疗技术有限公司 一种药剂递送装置、释药方法及应用其的释药胶囊
CN118221797B (zh) * 2024-04-28 2025-02-18 内蒙古工业大学 一种具有脱敏效果的乳球蛋白肽及其应用

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GR860984B (en) 1985-04-17 1986-08-18 Zymogenetics Inc Expression of factor vii and ix activities in mammalian cells
DE122007000007I2 (de) 1986-04-09 2010-12-30 Genzyme Corp Genetisch transformierte Tiere, die ein gewünschtes Protein in Milch absondern
FR2619314B1 (fr) 1987-08-11 1990-06-15 Transgene Sa Analogue du facteur viii, procede de preparation et composition pharmaceutique le contenant
AT405517B (de) 1997-02-27 1999-09-27 Immuno Ag Faktor x-deletionsmutanten und analoge davon
EP3603624A1 (en) * 2009-12-24 2020-02-05 Rani Therapeutics, LLC Therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US8759284B2 (en) * 2009-12-24 2014-06-24 Rani Therapeutics, Llc Therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US8809269B2 (en) 2010-12-23 2014-08-19 Rani Therapeutics, Llc Therapeutic agent preparations comprising insulin for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US8734429B2 (en) * 2010-12-23 2014-05-27 Rani Therapeutics, Llc Device, system and methods for the oral delivery of therapeutic compounds
US9629799B2 (en) * 2010-12-23 2017-04-25 Rani Therapeutics, Llc Therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US9149617B2 (en) * 2010-12-23 2015-10-06 Rani Therapeutics, Llc Device, system and methods for the oral delivery of therapeutic compounds
PT3513804T (pt) * 2011-07-08 2022-06-02 Bioverativ Therapeutics Inc Polipéptidos fator viii híbridos e quiméricos, e métodos de utilização dos mesmos
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US11548940B2 (en) * 2014-05-15 2023-01-10 Rani Therapeutics, Llc Anti-interleukin antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US10689460B2 (en) * 2014-05-15 2020-06-23 Incube Labs, Llc PCSK9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
CN113546036A (zh) * 2015-05-01 2021-10-26 拉尼医疗有限公司 药物组合物和用于制备包含多肽和/或蛋白质的固体块的方法
DK3347050T3 (da) * 2015-09-08 2025-04-14 Rani Therapeutics Llc PCSK9-antistofpræparater til afgivelse i et lumen i mave-tarmkanalen ved hjælp af en indtagelig enhed til afgivelse af lægemiddel
WO2017222337A1 (ko) * 2016-06-24 2017-12-28 재단법인 목암생명과학연구소 Fviii 및 vwf 인자를 포함하는 키메라 단백질 및 그 용도
CN106279437B (zh) * 2016-08-19 2017-10-31 安源医药科技(上海)有限公司 高糖基化人凝血因子viii融合蛋白及其制备方法与用途
MX2019006444A (es) * 2016-12-02 2019-10-30 Bioverativ Therapeutics Inc Métodos de tratamiento de artropatía hemofílica utilizando factores de coagulación quiméricos.
JP7370974B2 (ja) * 2017-11-07 2023-10-30 ラニ セラピューティクス, エルエルシー 嚥下可能薬物送達デバイスを使用する腸管組織への送達のための凝固因子調製物

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022218962A1 (en) * 2021-04-13 2022-10-20 Grifols Worldwide Operations Limited Liquid composition comprising factor viii or factor viii/von willebrand factor complex

Also Published As

Publication number Publication date
CN114007638A (zh) 2022-02-01
JP2022530615A (ja) 2022-06-30
EP3962516B1 (en) 2026-04-29
KR20220004148A (ko) 2022-01-11
EP3962516A4 (en) 2023-01-04
AU2020270420A1 (en) 2021-11-18
JP7692363B2 (ja) 2025-06-13
EP3962516A1 (en) 2022-03-09
WO2020227162A1 (en) 2020-11-12
MX2021013310A (es) 2022-02-11
AU2020270420B2 (en) 2026-03-26
US20220118056A1 (en) 2022-04-21
BR112021021904A2 (pt) 2022-02-22

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