KR102385372B1 - 동결건조된 ix 인자 제형 - Google Patents

동결건조된 ix 인자 제형 Download PDF

Info

Publication number
KR102385372B1
KR102385372B1 KR1020167028692A KR20167028692A KR102385372B1 KR 102385372 B1 KR102385372 B1 KR 102385372B1 KR 1020167028692 A KR1020167028692 A KR 1020167028692A KR 20167028692 A KR20167028692 A KR 20167028692A KR 102385372 B1 KR102385372 B1 KR 102385372B1
Authority
KR
South Korea
Prior art keywords
delete delete
formulation
fix
vial
concentration
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
KR1020167028692A
Other languages
English (en)
Korean (ko)
Other versions
KR20160137577A (ko
Inventor
브라이언 엠 톰
체리 파크허스트-랭
브랜든 더블유 리베일
Original Assignee
바이오버라티브 테라퓨틱스 인크.
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=KR102385372(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by 바이오버라티브 테라퓨틱스 인크. filed Critical 바이오버라티브 테라퓨틱스 인크.
Publication of KR20160137577A publication Critical patent/KR20160137577A/ko
Application granted granted Critical
Publication of KR102385372B1 publication Critical patent/KR102385372B1/ko
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

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)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (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)
  • Genetics & Genomics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (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)
  • Monitoring And Testing Of Transmission In General (AREA)
  • Mobile Radio Communication Systems (AREA)
KR1020167028692A 2014-03-24 2015-03-24 동결건조된 ix 인자 제형 Active KR102385372B1 (ko)

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

Publications (2)

Publication Number Publication Date
KR20160137577A KR20160137577A (ko) 2016-11-30
KR102385372B1 true KR102385372B1 (ko) 2022-04-11

Family

ID=54196282

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020167028692A Active KR102385372B1 (ko) 2014-03-24 2015-03-24 동결건조된 ix 인자 제형

Country Status (16)

Country Link
US (3) US10772942B2 (https=)
EP (1) EP3123090A4 (https=)
JP (4) JP7058940B2 (https=)
KR (1) KR102385372B1 (https=)
AR (1) AR099838A1 (https=)
AU (3) AU2015236340B2 (https=)
CA (1) CA2943034C (https=)
CL (1) CL2016002386A1 (https=)
EA (2) EA202092926A3 (https=)
IL (3) IL247869B (https=)
MA (1) MA39779A (https=)
MX (2) MX387269B (https=)
PH (1) PH12016501877A1 (https=)
SG (3) SG10201913735SA (https=)
TW (1) TWI700101B (https=)
WO (1) WO2015148444A1 (https=)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014144549A1 (en) * 2013-03-15 2014-09-18 Biogen Idec Ma Inc. Factor ix polypeptide formulations
AU2015236340B2 (en) 2014-03-24 2020-02-06 Bioverativ Therapeutics 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.
WO2019014338A1 (en) * 2017-07-11 2019-01-17 Universal Stabilization Technologies, Inc. METHOD FOR PRESERVING BIOPHARMACEUTICAL PRODUCTS
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
BR112022015272A2 (pt) 2020-02-04 2022-09-20 Regeneron Pharma Teor de umidade residual alvo para produto de fármaco liofilizado
US20210395325A1 (en) * 2020-05-11 2021-12-23 Alkermes Pharma Ireland Limited Il-2 fusion polypeptide compositions and methods of making and using the same
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 (3)

* 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
JP2009511495A (ja) * 2005-10-06 2009-03-19 ゼンコー・インコーポレイテッド 最適化された抗ｃｄ３０抗体
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

Family Cites Families (55)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3572982D1 (en) 1984-03-06 1989-10-19 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
JP3045539B2 (ja) 1989-02-21 2000-05-29 ワシントン ユニバーシティ 改変型生殖ホルモン
US6552170B1 (en) 1990-04-06 2003-04-22 Amgen Inc. PEGylation reagents and compounds formed therewith
ATE240740T1 (de) 1991-03-15 2003-06-15 Amgen Inc 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.
CA2124690C (en) 1992-10-02 2007-09-11 Thomas Osterberg 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
JP2001151694A (ja) 1999-09-17 2001-06-05 Takeda Chem Ind Ltd タンパク質粉体の製造法
CA2383144A1 (en) 1999-09-17 2001-03-29 Takeda Chemical Industries, Ltd. Process for producing protein powder
HUP0204475A2 (en) 2000-02-11 2003-04-28 Merck Patent Gmbh Enhancing the circulating half-life of antibody-based fusion proteins
WO2002040544A2 (en) 2000-11-14 2002-05-23 Board Of Regents, University 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.
AU2002364586A1 (en) 2001-12-21 2003-07-30 Delta Biotechnology Limited Albumin fusion proteins
US7348004B2 (en) 2003-05-06 2008-03-25 Syntonix Pharmaceuticals, Inc. Immunoglobulin chimeric monomer-dimer hybrids
PL2298347T3 (pl) 2003-05-06 2016-03-31 Bioverativ Therapeutics Inc Białka chimeryczne czynnika krzepnięcia do leczenia zaburzenia hemostazy
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
CN1917861B (zh) 2003-12-19 2012-03-21 诺和诺德医疗保健公司 因子vii多肽的稳定化固体组合物
BRPI0509117A (pt) 2004-03-04 2007-08-28 Wyeth Corp método de liofilização para melhorar a cristalização de excipientes
WO2006029467A1 (en) * 2004-09-16 2006-03-23 Btf Pty Ltd Rapid freeze drying process
PT2363414T (pt) 2004-11-12 2022-08-04 Bayer Healthcare Llc Modificação de fviii direcionada a sítio
US8367805B2 (en) 2004-11-12 2013-02-05 Xencor, Inc. Fc variants with altered binding to FcRn
AU2005317166B2 (en) 2004-12-15 2009-09-10 Biovitrum Ab (Publ) Therapeutic formulations of keratinocyte growth factor
US7956160B2 (en) 2005-07-22 2011-06-07 Amgen Inc. Concentrated protein lyophilates, methods, and uses
PL1942868T5 (pl) * 2005-11-01 2023-12-27 Wyeth Llc Roztwór chlorku sodu do odtwarzania lub rozcieńczania leku
US8048848B2 (en) 2006-02-03 2011-11-01 Prolor Biotech Ltd. Long-acting interferons and derivatives thereof and methods thereof
TWI428448B (zh) 2006-03-24 2014-03-01 Syntonix Pharmaceuticals Inc 作為第九因子（ｆａｃｔｏｒ ｉｘ）原肽處理酶之ｐｃ５
HUE042402T2 (hu) * 2006-04-04 2019-06-28 Chiesi Farm Spa Eljárás polipeptid töményítésére
EP2423307A1 (en) 2006-06-19 2012-02-29 Catalyst Biosciences, Inc. Modified coagulation factor IV 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
SI2173890T1 (sl) 2007-06-21 2011-06-30 Univ Muenchen Tech Biološko aktivni proteini, ki imajo povečano in vivo in/ali in vitro stabilnost
CN102026653B (zh) 2007-10-15 2014-06-18 北卡罗来纳-查佩尔山大学 半衰期延长的人因子ⅸ变体
BRPI0821591A2 (pt) 2007-12-21 2016-05-03 Inspiration Biopharmaceuticals Inc composição liofilizada e métodos de preparação de composição seca estável do fator ix e de liofilização de formulação farmacêutica
NZ603997A (en) 2007-12-27 2013-02-22 Baxter Int Chemically Modified Factor IX
JP2011517950A (ja) 2008-04-16 2011-06-23 バイエル・ヘルスケア・エルエルシー 第ｉｘ因子の部位特異的修飾
SG189790A1 (en) 2008-04-16 2013-05-31 Bayer Healthcare Llc Modified factor ix polypeptides and uses thereof
US20110137011A1 (en) 2008-04-21 2011-06-09 Novo Nordisk A/S Hyperglycosylated human coagulation factor ix
DK2280734T3 (da) 2008-04-24 2014-05-26 Cantab Biopharmaceuticals Patents Ltd Faktor-ix-konjugater med forlængede halveringstider
CA2729972C (en) 2008-08-05 2018-11-20 Wyeth Llc Lyophilization above collapse
MX2011003074A (es) 2008-09-24 2011-04-19 Stabilitech Ltd Metodo para conservar polipeptidos utilizando un azucar y polietilenimina.
JP2012530721A (ja) 2009-06-18 2012-12-06 ワイス・エルエルシー 小モジュール免疫薬のための凍結乾燥製剤
EP2458990B1 (en) * 2009-07-28 2016-03-30 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
EP2623497B1 (en) 2010-09-30 2016-01-20 Toyama Chemical Co., Ltd. Meglumine salt of 6-fluoro-3-hydroxy-2-pyrazine carboxamide
JP6125436B2 (ja) 2011-02-09 2017-05-10 グラクソスミスクライン・リミテッド・ライアビリティ・カンパニーＧｌａｘｏＳｍｉｔｈＫｌｉｎｅ ＬＬＣ 凍結乾燥製剤
WO2013185113A1 (en) * 2012-06-08 2013-12-12 Biogen Idec Ma Inc. Procoagulant compounds
HK1213521A1 (zh) * 2012-09-25 2016-07-08 Bioverativ Therapeutics Inc. Fix多肽的應用
WO2014144549A1 (en) 2013-03-15 2014-09-18 Biogen Idec Ma Inc. Factor ix polypeptide formulations
AU2015236340B2 (en) 2014-03-24 2020-02-06 Bioverativ Therapeutics Inc. Lyophilized factor IX formulations

Patent Citations (3)

* 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
JP2009511495A (ja) * 2005-10-06 2009-03-19 ゼンコー・インコーポレイテッド 最適化された抗ｃｄ３０抗体
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

Also Published As

Publication number Publication date
CA2943034A1 (en) 2015-10-01
TW201605492A (zh) 2016-02-16
EA202092926A3 (ru) 2021-10-29
US20170173122A1 (en) 2017-06-22
MX387269B (es) 2025-03-18
JP7058940B2 (ja) 2022-04-25
IL247869B (en) 2020-02-27
JP2017510585A (ja) 2017-04-13
AU2015236340B2 (en) 2020-02-06
IL247869A0 (en) 2016-11-30
AU2020202863A1 (en) 2020-05-21
JP2020063313A (ja) 2020-04-23
AU2022215218B2 (en) 2025-12-18
WO2015148444A1 (en) 2015-10-01
JP7503583B2 (ja) 2024-06-20
CL2016002386A1 (es) 2017-06-23
IL272257A (en) 2020-02-27
EA202092926A2 (ru) 2021-07-30
AU2020202863B2 (en) 2022-09-01
US20210069307A1 (en) 2021-03-11
SG10201808249VA (en) 2018-10-30
MA39779A (fr) 2017-02-01
IL281197A (en) 2021-04-29
KR20160137577A (ko) 2016-11-30
AU2022215218A1 (en) 2022-09-01
BR112016021777A2 (pt) 2017-10-03
NZ724351A (en) 2023-10-27
JP2022044689A (ja) 2022-03-17
JP2024053015A (ja) 2024-04-12
EA201691807A1 (ru) 2017-03-31
SG10201913735SA (en) 2020-03-30
IL281197B (en) 2022-06-01
US12128092B2 (en) 2024-10-29
EP3123090A1 (en) 2017-02-01
PH12016501877A1 (en) 2016-12-19
TWI700101B (zh) 2020-08-01
JP7759978B2 (ja) 2025-10-24
MX2021012939A (es) 2021-11-25
AR099838A1 (es) 2016-08-24
EA038573B1 (ru) 2021-09-16
CA2943034C (en) 2022-06-14
IL272257B (en) 2021-03-25
EP3123090A4 (en) 2017-12-13
AU2015236340A1 (en) 2016-09-29
US10772942B2 (en) 2020-09-15
SG11201607642RA (en) 2016-10-28
US20250121042A1 (en) 2025-04-17
MX2016012447A (es) 2017-01-06

Similar Documents

Publication Publication Date Title
AU2022204643B2 (en) Factor IX polypeptides and methods of use thereof
AU2022215218B2 (en) Lyophilized factor IX formulations
AU2019208273B2 (en) Factor IX polypeptide formulations
KR102212098B1 (ko) 키메라 인자 viii 폴리펩티드들과 이의 용도
US20240124555A1 (en) Optimized factor viii genes
US10927362B2 (en) Processable single chain molecules and polypeptides made using same
ES2959747T3 (es) Gen del factor VIII optimizado
TWI844042B (zh) 具有xten之凝血酶可裂解連接子及其用途
US20160229903A1 (en) Thrombin cleavable linker
TW202003554A (zh) 因子ｖｉｉｉ－ｘｔｅｎ融合物及其用途
TW202126284A (zh) 慢病毒載體配製物
JP2020504082A (ja) 血液凝固障害の処置又は予防における血管外投与のための切断型フォン・ヴィルブランド因子ポリペプチド
US20240287158A1 (en) Formulations of factor viii chimeric proteins and uses thereof
BR112016021777B1 (pt) Formulação de pré-liofilização, pó liofilizado, formulação reconstituída, frasco, kit, e uso de uma composição farmacêutica
EA045351B1 (ru) Лиофилизированный состав фактора ix для предупреждения или уменьшения приступов кровотечения при гемофилии b
NZ724351B2 (en) Lyophilized factor ix formulations

Legal Events

Date Code Title Description
PA0105 International application

St.27 status event code: A-0-1-A10-A15-nap-PA0105

PG1501 Laying open of application

St.27 status event code: A-1-1-Q10-Q12-nap-PG1501

R18-X000 Changes to party contact information recorded

St.27 status event code: A-3-3-R10-R18-oth-X000

N231 Notification of change of applicant
PN2301 Change of applicant

St.27 status event code: A-3-3-R10-R13-asn-PN2301

St.27 status event code: A-3-3-R10-R11-asn-PN2301

A201 Request for examination
E13-X000 Pre-grant limitation requested

St.27 status event code: A-2-3-E10-E13-lim-X000

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

PA0201 Request for examination

St.27 status event code: A-1-2-D10-D11-exm-PA0201

E902 Notification of reason for refusal
PE0902 Notice of grounds for rejection

St.27 status event code: A-1-2-D10-D21-exm-PE0902

E902 Notification of reason for refusal
PE0902 Notice of grounds for rejection

St.27 status event code: A-1-2-D10-D21-exm-PE0902

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

E701 Decision to grant or registration of patent right
PE0701 Decision of registration

St.27 status event code: A-1-2-D10-D22-exm-PE0701

R17-X000 Change to representative recorded

St.27 status event code: A-3-3-R10-R17-oth-X000

GRNT Written decision to grant
PR0701 Registration of establishment

St.27 status event code: A-2-4-F10-F11-exm-PR0701

PR1002 Payment of registration fee

St.27 status event code: A-2-2-U10-U12-oth-PR1002

Fee payment year number: 1

PG1601 Publication of registration

St.27 status event code: A-4-4-Q10-Q13-nap-PG1601

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 4

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 5

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U11-OTH-PR1001 (AS PROVIDED BY THE NATIONAL OFFICE)

Year of fee payment: 5