JP7058940B2 - 凍結乾燥第ix因子製剤 - Google Patents

凍結乾燥第ix因子製剤 Download PDF

Info

Publication number
JP7058940B2
JP7058940B2 JP2016558751A JP2016558751A JP7058940B2 JP 7058940 B2 JP7058940 B2 JP 7058940B2 JP 2016558751 A JP2016558751 A JP 2016558751A JP 2016558751 A JP2016558751 A JP 2016558751A JP 7058940 B2 JP7058940 B2 JP 7058940B2
Authority
JP
Japan
Prior art keywords
lyophilized
vial
concentration
fix
item
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
JP2016558751A
Other languages
English (en)
Japanese (ja)
Other versions
JP2017510585A (ja
JP2017510585A5 (enExample
Inventor
ブライアン エム. トーミー,
シェリー パーカースト-ラン,
ブランドン ダブリュー. レヴァイル,
Original Assignee
バイオベラティブ セラピューティクス インコーポレイテッド
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=JP7058940(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by バイオベラティブ セラピューティクス インコーポレイテッド filed Critical バイオベラティブ セラピューティクス インコーポレイテッド
Publication of JP2017510585A publication Critical patent/JP2017510585A/ja
Publication of JP2017510585A5 publication Critical patent/JP2017510585A5/ja
Priority to JP2022007013A priority Critical patent/JP7503583B2/ja
Application granted granted Critical
Publication of JP7058940B2 publication Critical patent/JP7058940B2/ja
Priority to JP2024033771A priority patent/JP7759978B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

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
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482Serine endopeptidases (3.4.21)
    • A61K38/4846Factor 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)
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y304/00Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21Serine endopeptidases (3.4.21)
    • C12Y304/21022Coagulation factor IXa (3.4.21.22)
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26DRYING
    • F26BDRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04Drying 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
    • F26B5/06Drying 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)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (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)
  • Immunology (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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)
  • Monitoring And Testing Of Transmission In General (AREA)
  • Mobile Radio Communication Systems (AREA)
JP2016558751A 2014-03-24 2015-03-24 凍結乾燥第ix因子製剤 Active JP7058940B2 (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2022007013A JP7503583B2 (ja) 2014-03-24 2022-01-20 凍結乾燥第ix因子製剤
JP2024033771A JP7759978B2 (ja) 2014-03-24 2024-03-06 凍結乾燥第ix因子製剤

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 (2)

Application Number Title Priority Date Filing Date
JP2020016131A Division JP2020063313A (ja) 2014-03-24 2020-02-03 凍結乾燥第ix因子製剤
JP2022007013A Division JP7503583B2 (ja) 2014-03-24 2022-01-20 凍結乾燥第ix因子製剤

Publications (3)

Publication Number Publication Date
JP2017510585A JP2017510585A (ja) 2017-04-13
JP2017510585A5 JP2017510585A5 (enExample) 2018-05-10
JP7058940B2 true JP7058940B2 (ja) 2022-04-25

Family

ID=54196282

Family Applications (4)

Application Number Title Priority Date Filing Date
JP2016558751A Active JP7058940B2 (ja) 2014-03-24 2015-03-24 凍結乾燥第ix因子製剤
JP2020016131A Pending JP2020063313A (ja) 2014-03-24 2020-02-03 凍結乾燥第ix因子製剤
JP2022007013A Active JP7503583B2 (ja) 2014-03-24 2022-01-20 凍結乾燥第ix因子製剤
JP2024033771A Active JP7759978B2 (ja) 2014-03-24 2024-03-06 凍結乾燥第ix因子製剤

Family Applications After (3)

Application Number Title Priority Date Filing Date
JP2020016131A Pending JP2020063313A (ja) 2014-03-24 2020-02-03 凍結乾燥第ix因子製剤
JP2022007013A Active JP7503583B2 (ja) 2014-03-24 2022-01-20 凍結乾燥第ix因子製剤
JP2024033771A Active JP7759978B2 (ja) 2014-03-24 2024-03-06 凍結乾燥第ix因子製剤

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) EA038573B1 (enExample)
IL (3) IL247869B (enExample)
MA (1) MA39779A (enExample)
MX (2) MX387269B (enExample)
PH (1) PH12016501877A1 (enExample)
SG (3) SG10201808249VA (enExample)
TW (1) TWI700101B (enExample)
WO (1) WO2015148444A1 (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2024053015A (ja) * 2014-03-24 2024-04-12 バイオベラティブ セラピューティクス インコーポレイテッド 凍結乾燥第ix因子製剤

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EA037906B1 (ru) * 2013-03-15 2021-06-04 Биовератив Терапьютикс Инк. Препараты полипептида фактора ix
WO2018102743A1 (en) * 2016-12-02 2018-06-07 Bioverativ Therapeutics Inc. Methods of treating hemophilic arthropathy using chimeric clotting factors
US11400051B2 (en) * 2017-07-11 2022-08-02 Universal Stabilization Technologies, Inc. Method for preserving biopharmaceuticals
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
AU2021217370A1 (en) * 2020-02-04 2022-08-18 Regeneron Pharmaceuticals, Inc. Target residual moisture content for lyophilized drug product
EP4149514A4 (en) * 2020-05-11 2024-06-26 Alkermes Pharma Ireland Limited IL-2 FUSION POLYPEPTIDE COMPOSITIONS AND METHODS OF MAKING AND USING THEM
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 (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002513390A (ja) 1996-10-16 2002-05-08 アルザ コーポレイション 低い反応性を有する非水性、無水の非プロトン性疎水性非極性ビヒクルを用いる安定なたんぱく質および核酸配合物
JP2006257099A (ja) 1996-01-25 2006-09-28 Genetics Inst Llc 高度に濃縮された、凍結乾燥された、および液体の、因子ix処方
JP2009513705A (ja) 2005-11-01 2009-04-02 ワイス 薬剤復元または希釈のための塩化ナトリウム溶液
US20120116054A1 (en) 2005-07-22 2012-05-10 Sampathkumar Krishnan Concentrated protein lyophilates, methods, and uses
JP2013534426A (ja) 2010-07-09 2013-09-05 バイオジェン アイデック ヘモフィリア インコーポレイテッド 第ix因子ポリペプチドおよびその使用方法
WO2013185113A1 (en) 2012-06-08 2013-12-12 Biogen Idec Ma Inc. Procoagulant compounds
JP2014051503A (ja) 2006-04-04 2014-03-20 Zymenex As ポリペプチドの濃縮方法

Family Cites Families (51)

* 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
JP2989002B2 (ja) 1988-12-22 1999-12-13 キリン―アムジエン・インコーポレーテツド 化学修飾顆粒球コロニー刺激因子
AU648020B2 (en) 1989-02-21 1994-04-14 Washington University Modified forms of reproductive hormones
US6552170B1 (en) 1990-04-06 2003-04-22 Amgen Inc. PEGylation reagents and compounds formed therewith
DE69233069T2 (de) 1991-03-15 2003-11-27 Amgen Inc., Thousand Oaks Pegylation von polypeptiden
FR2686899B1 (fr) 1992-01-31 1995-09-01 Rhone Poulenc Rorer Sa Nouveaux polypeptides biologiquement actifs, leur preparation et compositions pharmaceutiques les contenant.
CZ290342B6 (cs) 1992-10-02 2002-07-17 Genetics Institute Inc. Kompozice stabilní při skladování, obsahující koagulační faktor VIII a neiontovou povrchově aktivní látku a způsob její výroby
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
US20010031721A1 (en) 1999-05-05 2001-10-18 Chandra Webb Highly concentrated, lyophilized, and liquid factor IX formulations
CN1384751A (zh) 1999-09-17 2002-12-11 武田药品工业株式会社 蛋白粉生产方法
JP2001151694A (ja) 1999-09-17 2001-06-05 Takeda Chem Ind Ltd タンパク質粉体の製造法
DK1252192T3 (da) 2000-02-11 2006-11-20 Merck Patent Gmbh Forbedring af antistofbaserede fusionsproteiners serumhalveringstid
AU2002226028A1 (en) 2000-11-14 2002-05-27 Board Of Regents, Unversity Of Texas Systems Mutant human factor ix with an increased resistance to inhibition by heparin
MXPA04001982A (es) 2001-09-04 2004-06-07 Merck Patent Gmbh Factor ix modificado.
ES2425738T3 (es) 2001-12-21 2013-10-17 Human Genome Sciences, Inc. Proteínas de fusión de la albúmina
TWI353991B (en) * 2003-05-06 2011-12-11 Syntonix Pharmaceuticals Inc Immunoglobulin chimeric monomer-dimer hybrids
US7348004B2 (en) 2003-05-06 2008-03-25 Syntonix Pharmaceuticals, Inc. Immunoglobulin chimeric monomer-dimer hybrids
PT1624891E (pt) 2003-05-06 2010-01-05 Syntonix Pharmaceuticals Inc Proteínas quiméricas de factor de coagulação-fc destinadas ao tratamento da hemofilia
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
ES2676644T3 (es) 2003-12-19 2018-07-23 Novo Nordisk Health Care Ag Composiciones estabilizadas de polipéptidos de factor VII
EP1720519A1 (en) 2004-03-04 2006-11-15 Wyeth Lyophilization method to improve excipient crystallization
WO2006029467A1 (en) 2004-09-16 2006-03-23 Btf Pty Ltd Rapid freeze drying process
US8367805B2 (en) 2004-11-12 2013-02-05 Xencor, Inc. Fc variants with altered binding to FcRn
US7632921B2 (en) 2004-11-12 2009-12-15 Bayer Healthcare Llc Site-directed modification of FVIII
MX2007006822A (es) 2004-12-15 2007-07-24 Amgen Inc Formulaciones terapeuticas para el factor de crecimiento de queratinocitos.
US7973136B2 (en) * 2005-10-06 2011-07-05 Xencor, Inc. Optimized anti-CD30 antibodies
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
US8383388B2 (en) 2006-06-19 2013-02-26 Catalyst Biosciences, Inc. 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
HRP20110368T1 (hr) 2007-06-21 2011-06-30 Technische Universitt Mnchen Biološki aktivni proteini s povećanom stabilnošću in vivo i/ili in vitro
AU2008311973B2 (en) 2007-10-15 2013-10-03 Cangene Corporation Human Factor IX variants with an extended half life
CA2707032C (en) 2007-12-21 2019-09-24 Inspiration Biopharmaceuticals, Inc. Stabilized factor ix formulations containing trehalose
EP2568042A1 (en) 2007-12-27 2013-03-13 Baxter International Inc. Chemically modified factor IX
RU2010146387A (ru) 2008-04-16 2012-05-27 БАЙЕР ХЕЛСКЕР ЛЛСи (US) Модифицированные полипептиды фактора ix и их применение
WO2009140015A2 (en) 2008-04-16 2009-11-19 Bayer Healthcare Llc Site-directed modification of factor ix
EP2811017A2 (en) 2008-04-21 2014-12-10 Novo Nordisk Health Care AG Hyperglycosylated human coagulation factor IX
US20110183906A1 (en) 2008-04-24 2011-07-28 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
US20110236412A1 (en) 2008-09-24 2011-09-29 Stabilitech Ltd. Method for Preserving Polypeptides Using a Sugar and Polyethyleneimine
CN102695499A (zh) 2009-06-18 2012-09-26 惠氏有限责任公司 小模块免疫药物的冻干制剂
US20120121580A1 (en) * 2009-07-28 2012-05-17 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
MY161757A (en) 2010-09-30 2017-05-15 Toyama Chemical Co Ltd Meglumine salt of 6-fluoro-3-hydroxy-2-pyrazine carboxamide
MX2013009280A (es) 2011-02-09 2013-09-06 Glaxosmithkline Llc Formulaciones liofilizadas.
HK1213521A1 (zh) * 2012-09-25 2016-07-08 Bioverativ Therapeutics Inc. Fix多肽的應用
EA037906B1 (ru) 2013-03-15 2021-06-04 Биовератив Терапьютикс Инк. Препараты полипептида фактора ix
EP3123090A4 (en) 2014-03-24 2017-12-13 Bioverativ Therapeutics Inc. Lyophilized factor ix formulations

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006257099A (ja) 1996-01-25 2006-09-28 Genetics Inst Llc 高度に濃縮された、凍結乾燥された、および液体の、因子ix処方
JP2002513390A (ja) 1996-10-16 2002-05-08 アルザ コーポレイション 低い反応性を有する非水性、無水の非プロトン性疎水性非極性ビヒクルを用いる安定なたんぱく質および核酸配合物
US20120116054A1 (en) 2005-07-22 2012-05-10 Sampathkumar Krishnan Concentrated protein lyophilates, methods, and uses
JP2009513705A (ja) 2005-11-01 2009-04-02 ワイス 薬剤復元または希釈のための塩化ナトリウム溶液
JP2014051503A (ja) 2006-04-04 2014-03-20 Zymenex As ポリペプチドの濃縮方法
JP2013534426A (ja) 2010-07-09 2013-09-05 バイオジェン アイデック ヘモフィリア インコーポレイテッド 第ix因子ポリペプチドおよびその使用方法
WO2013185113A1 (en) 2012-06-08 2013-12-12 Biogen Idec Ma Inc. Procoagulant compounds

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2024053015A (ja) * 2014-03-24 2024-04-12 バイオベラティブ セラピューティクス インコーポレイテッド 凍結乾燥第ix因子製剤
JP7759978B2 (ja) 2014-03-24 2025-10-24 バイオベラティブ セラピューティクス インコーポレイテッド 凍結乾燥第ix因子製剤

Also Published As

Publication number Publication date
WO2015148444A1 (en) 2015-10-01
IL247869B (en) 2020-02-27
EP3123090A1 (en) 2017-02-01
IL272257B (en) 2021-03-25
JP2024053015A (ja) 2024-04-12
AU2020202863B2 (en) 2022-09-01
MX2016012447A (es) 2017-01-06
TW201605492A (zh) 2016-02-16
JP2022044689A (ja) 2022-03-17
AU2022215218B2 (en) 2025-12-18
EA202092926A2 (ru) 2021-07-30
JP2020063313A (ja) 2020-04-23
AU2015236340A1 (en) 2016-09-29
JP2017510585A (ja) 2017-04-13
EA201691807A1 (ru) 2017-03-31
TWI700101B (zh) 2020-08-01
SG10201913735SA (en) 2020-03-30
US20210069307A1 (en) 2021-03-11
US20250121042A1 (en) 2025-04-17
IL281197A (en) 2021-04-29
MX2021012939A (es) 2021-11-25
MX387269B (es) 2025-03-18
PH12016501877A1 (en) 2016-12-19
US10772942B2 (en) 2020-09-15
AU2022215218A1 (en) 2022-09-01
IL281197B (en) 2022-06-01
MA39779A (fr) 2017-02-01
EA202092926A3 (ru) 2021-10-29
AU2020202863A1 (en) 2020-05-21
CA2943034C (en) 2022-06-14
EP3123090A4 (en) 2017-12-13
JP7759978B2 (ja) 2025-10-24
NZ724351A (en) 2023-10-27
KR102385372B1 (ko) 2022-04-11
IL272257A (en) 2020-02-27
BR112016021777A2 (pt) 2017-10-03
EA038573B1 (ru) 2021-09-16
JP7503583B2 (ja) 2024-06-20
US12128092B2 (en) 2024-10-29
AR099838A1 (es) 2016-08-24
US20170173122A1 (en) 2017-06-22
KR20160137577A (ko) 2016-11-30
AU2015236340B2 (en) 2020-02-06
CL2016002386A1 (es) 2017-06-23
SG11201607642RA (en) 2016-10-28
SG10201808249VA (en) 2018-10-30
IL247869A0 (en) 2016-11-30
CA2943034A1 (en) 2015-10-01

Similar Documents

Publication Publication Date Title
JP7759978B2 (ja) 凍結乾燥第ix因子製剤
JP7636481B2 (ja) 第viii因子キメラおよびハイブリッドポリペプチドならびにその使用法
JP2022044828A (ja) 第ix因子ポリペプチドおよびその使用方法
TWI629993B (zh) 因子viii多肽調配物
HK40015680B (en) Factor ix polypeptides and methods of use thereof
HK40015680A (en) Factor ix polypeptides and methods of use thereof

Legal Events

Date Code Title Description
A711 Notification of change in applicant

Free format text: JAPANESE INTERMEDIATE CODE: A711

Effective date: 20171114

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20180323

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20180323

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20181108

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20181113

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20190212

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20190415

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20190802

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20191101

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20191219

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20200203

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20200427

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20200826

C60 Trial request (containing other claim documents, opposition documents)

Free format text: JAPANESE INTERMEDIATE CODE: C60

Effective date: 20200826

A911 Transfer to examiner for re-examination before appeal (zenchi)

Free format text: JAPANESE INTERMEDIATE CODE: A911

Effective date: 20200918

C21 Notice of transfer of a case for reconsideration by examiners before appeal proceedings

Free format text: JAPANESE INTERMEDIATE CODE: C21

Effective date: 20200923

A912 Re-examination (zenchi) completed and case transferred to appeal board

Free format text: JAPANESE INTERMEDIATE CODE: A912

Effective date: 20201023

C211 Notice of termination of reconsideration by examiners before appeal proceedings

Free format text: JAPANESE INTERMEDIATE CODE: C211

Effective date: 20201027

C22 Notice of designation (change) of administrative judge

Free format text: JAPANESE INTERMEDIATE CODE: C22

Effective date: 20210713

C13 Notice of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: C13

Effective date: 20210921

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20211213

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20220120

C23 Notice of termination of proceedings

Free format text: JAPANESE INTERMEDIATE CODE: C23

Effective date: 20220221

C03 Trial/appeal decision taken

Free format text: JAPANESE INTERMEDIATE CODE: C03

Effective date: 20220317

C30A Notification sent

Free format text: JAPANESE INTERMEDIATE CODE: C3012

Effective date: 20220317

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20220413

R150 Certificate of patent or registration of utility model

Ref document number: 7058940

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250