AU2015236340B2 - Lyophilized factor IX formulations - Google Patents

Lyophilized factor IX formulations Download PDF

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Publication number
AU2015236340B2
AU2015236340B2 AU2015236340A AU2015236340A AU2015236340B2 AU 2015236340 B2 AU2015236340 B2 AU 2015236340B2 AU 2015236340 A AU2015236340 A AU 2015236340A AU 2015236340 A AU2015236340 A AU 2015236340A AU 2015236340 B2 AU2015236340 B2 AU 2015236340B2
Authority
AU
Australia
Prior art keywords
fix
vial
formulation
polypeptide
lyophilization
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.)
Withdrawn - After Issue
Application number
AU2015236340A
Other languages
English (en)
Other versions
AU2015236340A1 (en
Inventor
Brandon W. LEVEILLE
Cherie Parkhurst-Lang
Brian M. THOME
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.)
Bioverativ Therapeutics Inc
Original Assignee
Bioverativ Therapeutics Inc
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=54196282&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2015236340(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Bioverativ Therapeutics Inc filed Critical Bioverativ Therapeutics Inc
Publication of AU2015236340A1 publication Critical patent/AU2015236340A1/en
Assigned to BIOVERATIV THERAPEUTICS INC. reassignment BIOVERATIV THERAPEUTICS INC. Request for Assignment Assignors: BIOGEN MA INC.
Application granted granted Critical
Publication of AU2015236340B2 publication Critical patent/AU2015236340B2/en
Priority to AU2020202863A priority Critical patent/AU2020202863B2/en
Priority to AU2022215218A priority patent/AU2022215218B2/en
Withdrawn - After Issue legal-status Critical Current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
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
    • 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
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21022—Coagulation factor IXa (3.4.21.22)
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00—Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
    • F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • General Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mechanical Engineering (AREA)
  • Genetics & Genomics (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Mobile Radio Communication Systems (AREA)
  • Monitoring And Testing Of Transmission In General (AREA)
AU2015236340A 2014-03-24 2015-03-24 Lyophilized factor IX formulations Withdrawn - After Issue AU2015236340B2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2020202863A AU2020202863B2 (en) 2014-03-24 2020-04-30 Lyophilized factor IX formulations
AU2022215218A AU2022215218B2 (en) 2014-03-24 2022-08-10 Lyophilized factor IX formulations

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201461969801P 2014-03-24 2014-03-24
US61/969,801 2014-03-24
PCT/US2015/022141 WO2015148444A1 (en) 2014-03-24 2015-03-24 Lyophilized factor ix formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2020202863A Division AU2020202863B2 (en) 2014-03-24 2020-04-30 Lyophilized factor IX formulations

Publications (2)

Publication Number Publication Date
AU2015236340A1 AU2015236340A1 (en) 2016-09-29
AU2015236340B2 true AU2015236340B2 (en) 2020-02-06

Family

ID=54196282

Family Applications (3)

Application Number Title Priority Date Filing Date
AU2015236340A Withdrawn - After Issue AU2015236340B2 (en) 2014-03-24 2015-03-24 Lyophilized factor IX formulations
AU2020202863A Active AU2020202863B2 (en) 2014-03-24 2020-04-30 Lyophilized factor IX formulations
AU2022215218A Active AU2022215218B2 (en) 2014-03-24 2022-08-10 Lyophilized factor IX formulations

Family Applications After (2)

Application Number Title Priority Date Filing Date
AU2020202863A Active AU2020202863B2 (en) 2014-03-24 2020-04-30 Lyophilized factor IX formulations
AU2022215218A Active AU2022215218B2 (en) 2014-03-24 2022-08-10 Lyophilized factor IX formulations

Country Status (16)

Country Link
US (3) US10772942B2 (enExample)
EP (1) EP3123090A4 (enExample)
JP (4) JP7058940B2 (enExample)
KR (1) KR102385372B1 (enExample)
AR (1) AR099838A1 (enExample)
AU (3) AU2015236340B2 (enExample)
CA (1) CA2943034C (enExample)
CL (1) CL2016002386A1 (enExample)
EA (2) EA202092926A3 (enExample)
IL (3) IL247869B (enExample)
MA (1) MA39779A (enExample)
MX (2) MX387269B (enExample)
PH (1) PH12016501877A1 (enExample)
SG (3) SG11201607642RA (enExample)
TW (1) TWI700101B (enExample)
WO (1) WO2015148444A1 (enExample)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI828269B (zh) * 2013-03-15 2024-01-01 美商百歐維拉提夫治療公司 因子ix多肽調配物
SG11201605242YA (en) 2014-01-10 2016-07-28 Biogen Ma Inc Factor viii chimeric proteins and uses thereof
SG11201607642RA (en) 2014-03-24 2016-10-28 Biogen Ma Inc Lyophilized factor ix formulations
MX2019006444A (es) * 2016-12-02 2019-10-30 Bioverativ Therapeutics Inc Métodos de tratamiento de artropatía hemofílica utilizando factores de coagulación quiméricos.
MX421254B (es) * 2017-07-11 2025-02-10 Universal Stabilization Tech Inc Método para la conservación de material biológico.
CN112175088B (zh) * 2019-07-02 2023-03-28 江苏晟斯生物制药有限公司 改进的fix融合蛋白、缀合物及其应用
CN115151772B (zh) 2020-02-04 2024-11-15 瑞泽恩制药公司 冻干药物产品的目标残留水分含量
CN115867307A (zh) * 2020-05-11 2023-03-28 奥克梅斯制药爱尔兰有限公司 Il-2融合多肽组合物以及其制备和使用方法
CN118557531B (zh) * 2024-08-02 2024-10-18 成都蓉生药业有限责任公司 一种重组人凝血因子VIII-Fc融合蛋白冻干制剂的制备方法

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010038859A1 (en) * 1996-10-16 2001-11-08 Maskiewicz Victoria Knepp Stable protein and nucleic acid formulations using non-aqueous, anhydrous, aprotic, hydrophobic, non-polar vehicles with low reactivity

Family Cites Families (57)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0154316B1 (en) 1984-03-06 1989-09-13 Takeda Chemical Industries, Ltd. Chemically modified lymphokine and production thereof
WO1990006952A1 (fr) 1988-12-22 1990-06-28 Kirin-Amgen, Inc. Facteur de stimulation de colonies de granulocytes modifies chimiquement
ATE148171T1 (de) 1989-02-21 1997-02-15 Univ Washington Modifizierte formen von fortpflanzungshormonen
US6552170B1 (en) 1990-04-06 2003-04-22 Amgen Inc. PEGylation reagents and compounds formed therewith
GEP20033082B (en) 1991-03-15 2003-10-27 Amgen Inc Pegylation of Polypeptides
FR2686899B1 (fr) 1992-01-31 1995-09-01 Rhone Poulenc Rorer Sa Nouveaux polypeptides biologiquement actifs, leur preparation et compositions pharmaceutiques les contenant.
WO1994007510A1 (en) * 1992-10-02 1994-04-14 Kabi Pharmacia Ab Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer
DE4405426A1 (de) * 1994-02-21 1995-08-24 Boehringer Mannheim Gmbh Pharmazeutisches Präparat enthaltend Plasminogenaktivator (t-PA) oder dessen Derivate
US6372716B1 (en) 1994-04-26 2002-04-16 Genetics Institute, Inc. Formulations for factor IX
US6685940B2 (en) 1995-07-27 2004-02-03 Genentech, Inc. Protein formulation
US5770700A (en) * 1996-01-25 1998-06-23 Genetics Institute, Inc. Liquid factor IX formulations
US20010031721A1 (en) 1999-05-05 2001-10-18 Chandra Webb Highly concentrated, lyophilized, and liquid factor IX formulations
CA2383144A1 (en) * 1999-09-17 2001-03-29 Takeda Chemical Industries, Ltd. Process for producing protein powder
JP2001151694A (ja) 1999-09-17 2001-06-05 Takeda Chem Ind Ltd タンパク質粉体の製造法
JP5179689B2 (ja) 2000-02-11 2013-04-10 メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフツング 抗体ベース融合タンパク質の循環系内半減期の増強
US7125841B2 (en) 2000-11-14 2006-10-24 The University Of Texas Systems Mutant human factor IX with an increased resistance to inhibition by heparin
JP2005501547A (ja) 2001-09-04 2005-01-20 メルク　パテント　ゲゼルシャフト　ミット　ベシュレンクテル　ハフトング 修飾された第ｉｘ因子
PT1463751E (pt) 2001-12-21 2013-08-26 Human Genome Sciences Inc Proteínas de fusão de albumina
US7348004B2 (en) 2003-05-06 2008-03-25 Syntonix Pharmaceuticals, Inc. Immunoglobulin chimeric monomer-dimer hybrids
ES2333598T5 (es) 2003-05-06 2013-09-04 Biogen Idec Hemophilia Inc Proteinas quimericas del factor de coagulacion fc para tratar la hemofilia.
TWI353991B (en) * 2003-05-06 2011-12-11 Syntonix Pharmaceuticals Inc Immunoglobulin chimeric monomer-dimer hybrids
JP2005060378A (ja) 2003-07-28 2005-03-10 Yamanouchi Pharmaceut Co Ltd 生理活性蛋白質含有凍結乾燥製剤
US20050152979A1 (en) 2003-09-05 2005-07-14 Cell Therapeutics, Inc. Hydrophobic drug compositions containing reconstitution enhancer
KR20150138427A (ko) 2003-12-19 2015-12-09 노보 노르디스크 헬스 케어 악티엔게젤샤프트 인자 ｖｉｉ 폴리펩티드의 안정화된 조성물
AU2005225000A1 (en) 2004-03-04 2005-09-29 Wyeth Lyophilization method to improve excipient crystallization
WO2006029467A1 (en) * 2004-09-16 2006-03-23 Btf Pty Ltd Rapid freeze drying process
KR101468345B1 (ko) 2004-11-12 2014-12-03 바이엘 헬스케어 엘엘씨 Ｆｖｉｉｉ의 부위 지향 변형
US8367805B2 (en) 2004-11-12 2013-02-05 Xencor, Inc. Fc variants with altered binding to FcRn
CA2589889C (en) 2004-12-15 2013-07-30 Amgen Inc. Therapeutic formulations of keratinocyte growth factor
EP2377554A1 (en) * 2005-07-22 2011-10-19 Amgen, Inc Concentrated protein lyophilates, methods and uses
JP4860703B2 (ja) * 2005-10-06 2012-01-25 ゼンコー・インコーポレイテッド 最適化された抗ｃｄ３０抗体
US20070135343A1 (en) 2005-11-01 2007-06-14 Wyeth Sodium chloride solution for drug reconstitution or dilution
US8048848B2 (en) 2006-02-03 2011-11-01 Prolor Biotech Ltd. Long-acting interferons and derivatives thereof and methods thereof
HRP20160990T1 (hr) 2006-03-24 2016-10-07 Biogen Hemophilia Inc. Pc5 kao enzim obrade faktor ix propeptida
MX2008012748A (es) 2006-04-04 2009-01-07 Shire Pharmaceuticals Ireland Un proceso para la concentracion de un polipeptido.
WO2007149406A2 (en) 2006-06-19 2007-12-27 Nautilus Technology Llc Modified coagulation factor ix polypeptides and use thereof for treatment
US8015841B2 (en) * 2006-09-08 2011-09-13 Praxair Technology, Inc. Cryogenic refrigeration system for lyophilization
US7700734B2 (en) 2007-01-09 2010-04-20 Shu-Wha Lin Recombinant human factor IX and use thereof
JP5351889B2 (ja) 2007-06-21 2013-11-27 テクニシェ ユニバーシタット ミュンヘン インビボおよび／またはインビトロ安定性が増大した生物学的に活性なタンパク質
EP2209487A4 (en) 2007-10-15 2012-06-20 Univ North Carolina Human factor ix variants with an extended half life
AU2008340304B2 (en) 2007-12-21 2016-03-03 Aptevo Biotherapeutics Llc Stabilized factor IX formulations containing trehalose
AU2008342260B2 (en) 2007-12-27 2013-10-17 Baxter Healthcare S.A. Chemically modified Factor IX
MX2010011345A (es) 2008-04-16 2011-02-23 Bayer Healthcare Llc Polipeptidos modificados del factor ix y usos de los mismos.
CA2721362A1 (en) 2008-04-16 2009-11-19 Bayer Healthcare Llc Site-directed modification of factor ix
JP5665733B2 (ja) 2008-04-21 2015-02-04 ノボ ノルディスク ヘルス ケア アーゲー 高度にグリコシル化されたヒト凝固第ｉｘ因子
WO2009130602A2 (en) 2008-04-24 2009-10-29 Celtic Pharma Peg Ltd. Factor ix conjugates with extended half-lives
ES2968301T3 (es) 2008-08-05 2024-05-08 Wyeth Llc Liofilización por encima del colapso
JP2012503637A (ja) 2008-09-24 2012-02-09 スタビリテック リミテッド 糖およびポリエチレンイミンを使用するポリペプチドの保存方法
CA2764180A1 (en) 2009-06-18 2010-12-23 Wyeth Llc Lyophilized formulations for small modular immunopharmaceuticals
EP2458990B1 (en) * 2009-07-28 2016-03-30 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
PT3552619T (pt) * 2010-07-09 2025-10-23 Bioverativ Therapeutics Inc Polipéptidos de fator ix e métodos de uso dos mesmos
ES2561878T3 (es) 2010-09-30 2016-03-01 Toyama Chemical Co., Ltd. Sal de meglumina de 6-fluoro-3-hidroxi-2-pirazinacarboxamida
DK2672986T3 (da) 2011-02-09 2020-06-08 Glaxosmithkline Llc Frysetørrede formuleringer
AU2013270682A1 (en) 2012-06-08 2014-12-11 Biogen Ma Inc. Procoagulant compounds
TWI810729B (zh) * 2012-09-25 2023-08-01 美商百歐維拉提夫治療公司 Ｆｉｘ多肽的應用
TWI828269B (zh) 2013-03-15 2024-01-01 美商百歐維拉提夫治療公司 因子ix多肽調配物
SG11201607642RA (en) * 2014-03-24 2016-10-28 Biogen Ma Inc Lyophilized factor ix formulations

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010038859A1 (en) * 1996-10-16 2001-11-08 Maskiewicz Victoria Knepp Stable protein and nucleic acid formulations using non-aqueous, anhydrous, aprotic, hydrophobic, non-polar vehicles with low reactivity

Also Published As

Publication number Publication date
AU2022215218B2 (en) 2025-12-18
JP7503583B2 (ja) 2024-06-20
US20170173122A1 (en) 2017-06-22
KR20160137577A (ko) 2016-11-30
MX2021012939A (es) 2021-11-25
IL247869A0 (en) 2016-11-30
JP7058940B2 (ja) 2022-04-25
SG10201913735SA (en) 2020-03-30
AU2022215218A1 (en) 2022-09-01
EP3123090A1 (en) 2017-02-01
IL281197A (en) 2021-04-29
IL281197B (en) 2022-06-01
US10772942B2 (en) 2020-09-15
NZ724351A (en) 2023-10-27
TWI700101B (zh) 2020-08-01
CA2943034C (en) 2022-06-14
EA201691807A1 (ru) 2017-03-31
MX387269B (es) 2025-03-18
MX2016012447A (es) 2017-01-06
SG11201607642RA (en) 2016-10-28
EP3123090A4 (en) 2017-12-13
AR099838A1 (es) 2016-08-24
AU2020202863B2 (en) 2022-09-01
SG10201808249VA (en) 2018-10-30
US20210069307A1 (en) 2021-03-11
AU2015236340A1 (en) 2016-09-29
JP2024053015A (ja) 2024-04-12
PH12016501877A1 (en) 2016-12-19
EA202092926A2 (ru) 2021-07-30
EA038573B1 (ru) 2021-09-16
IL272257B (en) 2021-03-25
IL247869B (en) 2020-02-27
CL2016002386A1 (es) 2017-06-23
AU2020202863A1 (en) 2020-05-21
MA39779A (fr) 2017-02-01
JP7759978B2 (ja) 2025-10-24
TW201605492A (zh) 2016-02-16
KR102385372B1 (ko) 2022-04-11
IL272257A (en) 2020-02-27
US20250121042A1 (en) 2025-04-17
EA202092926A3 (ru) 2021-10-29
US12128092B2 (en) 2024-10-29
CA2943034A1 (en) 2015-10-01
WO2015148444A1 (en) 2015-10-01
JP2017510585A (ja) 2017-04-13
JP2022044689A (ja) 2022-03-17
JP2020063313A (ja) 2020-04-23
BR112016021777A2 (pt) 2017-10-03

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