AU2013205684B2 - Reconstituted hdl formulation - Google Patents

Reconstituted hdl formulation Download PDF

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Publication number
AU2013205684B2
AU2013205684B2 AU2013205684A AU2013205684A AU2013205684B2 AU 2013205684 B2 AU2013205684 B2 AU 2013205684B2 AU 2013205684 A AU2013205684 A AU 2013205684A AU 2013205684 A AU2013205684 A AU 2013205684A AU 2013205684 B2 AU2013205684 B2 AU 2013205684B2
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AU
Australia
Prior art keywords
rhdl
formulation according
rhdl formulation
apolipoprotein
sucrose
Prior art date
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Active
Application number
AU2013205684A
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English (en)
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AU2013205684A1 (en
Inventor
Yvonne VUCICA
Gary Lee WARREN
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.)
CSL Ltd
Original Assignee
CSL Ltd
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 CSL Ltd filed Critical CSL Ltd
Priority to JP2015539998A priority Critical patent/JP6340372B2/ja
Priority to CN201711141045.0A priority patent/CN108057023B/zh
Priority to US14/439,094 priority patent/US9925236B2/en
Priority to CA2889785A priority patent/CA2889785C/en
Priority to MX2015004546A priority patent/MX364587B/es
Priority to KR1020157014530A priority patent/KR102263810B1/ko
Priority to HUE13851610A priority patent/HUE042620T2/hu
Priority to HK16100504.1A priority patent/HK1212599B/en
Priority to EP19151328.2A priority patent/EP3502131A1/en
Priority to PL13851610T priority patent/PL2916857T3/pl
Priority to SG11201503083UA priority patent/SG11201503083UA/en
Priority to EP13851610.9A priority patent/EP2916857B1/en
Priority to DK13851610.9T priority patent/DK2916857T3/en
Priority to NZ631131A priority patent/NZ631131A/en
Priority to ES13851610T priority patent/ES2719275T3/es
Priority to BR112015009748-0A priority patent/BR112015009748B1/pt
Priority to PCT/AU2013/001260 priority patent/WO2014066943A1/en
Priority to CN201380057007.0A priority patent/CN104755096B/zh
Priority to RU2015120808A priority patent/RU2669568C2/ru
Priority to TR2019/05244T priority patent/TR201905244T4/tr
Publication of AU2013205684A1 publication Critical patent/AU2013205684A1/en
Priority to IL238504A priority patent/IL238504B/en
Application granted granted Critical
Publication of AU2013205684B2 publication Critical patent/AU2013205684B2/en
Priority to US15/894,397 priority patent/US10603355B2/en
Priority to US16/826,585 priority patent/US11464828B2/en
Priority to US17/902,580 priority patent/US11957731B2/en
Priority to US18/634,576 priority patent/US20250099537A1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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    • 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
    • A61K38/1703Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • A61K38/1709Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • 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
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/24Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/02Nutrients, e.g. vitamins, minerals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/775Apolipopeptides

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Biophysics (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Genetics & Genomics (AREA)
  • Toxicology (AREA)
  • Dermatology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Nutrition Science (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
AU2013205684A 2012-11-02 2013-04-10 Reconstituted hdl formulation Active AU2013205684B2 (en)

Priority Applications (25)

Application Number Priority Date Filing Date Title
ES13851610T ES2719275T3 (es) 2012-11-02 2013-10-31 Formulación de lipoproteína de alta densidad reconstituida
US14/439,094 US9925236B2 (en) 2012-11-02 2013-10-31 Reconstituted HDL formulation
CA2889785A CA2889785C (en) 2012-11-02 2013-10-31 Reconstituted hdl formulation
MX2015004546A MX364587B (es) 2012-11-02 2013-10-31 Formulaciones reconstituidas de hdl.
KR1020157014530A KR102263810B1 (ko) 2012-11-02 2013-10-31 재구성된 hdl 제형
HUE13851610A HUE042620T2 (hu) 2012-11-02 2013-10-31 Rekonstituált HDL-készítmény
HK16100504.1A HK1212599B (en) 2012-11-02 2013-10-31 Reconstituted hdl formulation
EP19151328.2A EP3502131A1 (en) 2012-11-02 2013-10-31 Reconstituted hdl formulation
PL13851610T PL2916857T3 (pl) 2012-11-02 2013-10-31 Odtworzona formulacja HDL
SG11201503083UA SG11201503083UA (en) 2012-11-02 2013-10-31 Reconstituted hdl formulation
EP13851610.9A EP2916857B1 (en) 2012-11-02 2013-10-31 Reconstituted hdl formulation
DK13851610.9T DK2916857T3 (en) 2012-11-02 2013-10-31 RECONSTITUTED HDL FORMULATION
JP2015539998A JP6340372B2 (ja) 2012-11-02 2013-10-31 再構成されたhdl製剤
BR112015009748-0A BR112015009748B1 (pt) 2012-11-02 2013-10-31 Formulação de hdl reconstituída, seu método de produção e seu uso
PCT/AU2013/001260 WO2014066943A1 (en) 2012-11-02 2013-10-31 Reconstituted hdl formulation
NZ631131A NZ631131A (en) 2012-11-02 2013-10-31 Reconstituted hdl formulation
CN201380057007.0A CN104755096B (zh) 2012-11-02 2013-10-31 重构的hdl配制剂
RU2015120808A RU2669568C2 (ru) 2012-11-02 2013-10-31 Восстанавливаемый состав hdl
TR2019/05244T TR201905244T4 (tr) 2012-11-02 2013-10-31 Sulandırılarak hazırlanan HDL formülasyonu.
CN201711141045.0A CN108057023B (zh) 2012-11-02 2013-10-31 重构的hdl配制剂
IL238504A IL238504B (en) 2012-11-02 2015-04-28 A reconstituted hdl preparation
US15/894,397 US10603355B2 (en) 2012-11-02 2018-02-12 Reconstructed HDL formulation
US16/826,585 US11464828B2 (en) 2012-11-02 2020-03-23 Reconstituted HDL formulation
US17/902,580 US11957731B2 (en) 2012-11-02 2022-09-02 Reconstituted HDL formulation
US18/634,576 US20250099537A1 (en) 2012-11-02 2024-04-12 Reconstituted HDL Formulation

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201261721771P 2012-11-02 2012-11-02
US61/721,771 2012-11-02
EP13153903.3 2013-02-04
EP13153903 2013-02-04

Publications (2)

Publication Number Publication Date
AU2013205684A1 AU2013205684A1 (en) 2014-05-22
AU2013205684B2 true AU2013205684B2 (en) 2015-08-20

Family

ID=47665977

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2013205684A Active AU2013205684B2 (en) 2012-11-02 2013-04-10 Reconstituted hdl formulation

Country Status (15)

Country Link
US (6) US9125943B2 (enExample)
EP (2) EP3502131A1 (enExample)
JP (1) JP6340372B2 (enExample)
KR (1) KR102263810B1 (enExample)
CN (2) CN108057023B (enExample)
AU (1) AU2013205684B2 (enExample)
BR (1) BR112015009748B1 (enExample)
CA (1) CA2889785C (enExample)
IL (1) IL238504B (enExample)
MX (1) MX364587B (enExample)
NZ (1) NZ631131A (enExample)
PL (1) PL2916857T3 (enExample)
RU (1) RU2669568C2 (enExample)
SG (1) SG11201503083UA (enExample)
WO (1) WO2014066943A1 (enExample)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018085890A1 (en) * 2016-11-10 2018-05-17 Csl Limited Reconstituted high density lipoprotein treatment of myocardial infarction
RU2798830C2 (ru) * 2016-11-10 2023-06-28 СиЭсЭл ЛИМИТЕД Лечение восстановленным липопротеином высокой плотности инфаркта миокарда

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2617977T3 (es) 2010-06-30 2017-06-20 Csl Limited Una formulación de lipoproteína de alta densidad reconstituida y método de producción de la misma
US9125943B2 (en) * 2012-11-02 2015-09-08 Csl Limited Reconstituted HDL formulation
NZ631116A (en) * 2013-06-05 2018-07-27 Csl Ltd Process for preparing apolipoprotein a-i (apo a-i)
CA2920391C (en) 2013-08-08 2023-03-28 Csl Limited Contaminant removal method
BR112019001459A2 (pt) 2016-07-27 2019-05-07 Hartis-Pharma Sa combinação, composição farmacêutica, e, método de prevenção e/ou de tratamento de uma doença ou de um distúrbio.
CN112546201A (zh) * 2019-09-26 2021-03-26 中国科学院生物物理研究所 人工脂蛋白颗粒apoA-Ⅳ脂肪体在治疗和/或预防糖尿病中的应用
WO2025185021A1 (zh) * 2024-03-05 2025-09-12 维康平生(北京)生物科技有限公司 一种脂肪体的冷冻干燥方法

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5652339A (en) * 1993-12-31 1997-07-29 Rotkreuzstiftung Zentrallaboratorium Method of producing reconstituted lipoproteins
WO2007098122A2 (en) * 2006-02-17 2007-08-30 Pfizer, Inc. Methods for the treatment of macular degeneration and related eye conditions
KR20080062328A (ko) * 2006-12-29 2008-07-03 주식회사 녹십자 ApoA-I의 정제방법 및 정제된ApoA-I을 이용한재구축 HDL의 생산 방법
WO2012000048A1 (en) * 2010-06-30 2012-01-05 Csl Limited A reconstituted high density lipoprotein formulation and production method thereof

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA1335077C (en) * 1988-02-08 1995-04-04 Henri Isliker Process for the manufacture of apolipoproteins from human blood plasma or serum
PL372925A1 (en) 2001-09-28 2005-08-08 Esperion Therapeutics Inc. Prevention and treatment of restenosis by local administration of drug
MXPA04011312A (es) 2002-05-17 2005-02-14 Esperion Therapeutics Inc Metodo para el tratamiento de desordenes dislipidemicos.
BR0310100A (pt) 2002-05-17 2007-04-27 Esperion Therapeutics Inc métodos para tratar, prevenir ou reduzir a lesão de reperfusão isquêmica em um tecido ou órgão, e para prevenir ou tratar de uma condição associada com a privação de oxigênio, seguida por suprimento de oxigênio aumentado a um tecido ou órgão em necessidade disto
PE20050438A1 (es) 2003-10-20 2005-06-14 Esperion Therapeutics Inc Formulas farmaceuticas, metodos y regimenes de dosificacion para el tratamiento y la prevencion de sindromes coronarios agudos
NZ582170A (en) 2007-08-17 2012-02-24 Csl Behring Gmbh Methods for purification of alpha-1-antitrypsin and apolipoprotein a-i
US8734853B2 (en) 2008-11-17 2014-05-27 University Of North Texas Health Science Center At Fort Worth HDL particles for delivery of nucleic acids
RS58275B1 (sr) 2011-02-07 2019-03-29 Cerenis Therapeutics Holding Sa Lipoproteinski kompleksi i njihova proizvodnja i upotrebe
US9125943B2 (en) * 2012-11-02 2015-09-08 Csl Limited Reconstituted HDL formulation

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5652339A (en) * 1993-12-31 1997-07-29 Rotkreuzstiftung Zentrallaboratorium Method of producing reconstituted lipoproteins
WO2007098122A2 (en) * 2006-02-17 2007-08-30 Pfizer, Inc. Methods for the treatment of macular degeneration and related eye conditions
KR20080062328A (ko) * 2006-12-29 2008-07-03 주식회사 녹십자 ApoA-I의 정제방법 및 정제된ApoA-I을 이용한재구축 HDL의 생산 방법
WO2012000048A1 (en) * 2010-06-30 2012-01-05 Csl Limited A reconstituted high density lipoprotein formulation and production method thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
Lerch et al (1996) Vox Sanguinis, September, 71(3):155-164 *

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018085890A1 (en) * 2016-11-10 2018-05-17 Csl Limited Reconstituted high density lipoprotein treatment of myocardial infarction
RU2798830C2 (ru) * 2016-11-10 2023-06-28 СиЭсЭл ЛИМИТЕД Лечение восстановленным липопротеином высокой плотности инфаркта миокарда
AU2017358402B2 (en) * 2016-11-10 2023-10-05 Csl Limited Reconstituted high density lipoprotein treatment of myocardial infarction
IL266428B1 (en) * 2016-11-10 2024-08-01 Csl Ltd Reconstituted high density lipoprotein treatment of myocardial infarction

Also Published As

Publication number Publication date
US10603355B2 (en) 2020-03-31
US9125943B2 (en) 2015-09-08
RU2015120808A (ru) 2016-12-20
US20140221272A1 (en) 2014-08-07
US20190015476A1 (en) 2019-01-17
US20150306176A1 (en) 2015-10-29
IL238504B (en) 2018-02-28
US11464828B2 (en) 2022-10-11
CA2889785C (en) 2022-07-19
AU2013205684A1 (en) 2014-05-22
US20250099537A1 (en) 2025-03-27
CN104755096A (zh) 2015-07-01
CA2889785A1 (en) 2014-05-08
BR112015009748B1 (pt) 2021-04-27
PL2916857T3 (pl) 2019-06-28
NZ631131A (en) 2015-12-24
SG11201503083UA (en) 2015-05-28
CN104755096B (zh) 2017-10-13
KR20150079947A (ko) 2015-07-08
US11957731B2 (en) 2024-04-16
MX2015004546A (es) 2015-07-14
KR102263810B1 (ko) 2021-06-15
CN108057023A (zh) 2018-05-22
EP2916857A4 (en) 2016-05-25
HK1212599A1 (en) 2016-06-17
US20230142696A1 (en) 2023-05-11
MX364587B (es) 2019-05-02
IL238504A0 (en) 2015-06-30
BR112015009748A2 (pt) 2017-07-11
EP3502131A1 (en) 2019-06-26
JP2015535263A (ja) 2015-12-10
WO2014066943A1 (en) 2014-05-08
JP6340372B2 (ja) 2018-06-06
US20200397859A1 (en) 2020-12-24
CN108057023B (zh) 2022-02-08
US9925236B2 (en) 2018-03-27
RU2669568C2 (ru) 2018-10-12
EP2916857B1 (en) 2019-01-16
EP2916857A1 (en) 2015-09-16

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