TW201521761A - 重組體fviii調配物 - Google Patents

重組體fviii調配物 Download PDF

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Publication number
TW201521761A
TW201521761A TW103109012A TW103109012A TW201521761A TW 201521761 A TW201521761 A TW 201521761A TW 103109012 A TW103109012 A TW 103109012A TW 103109012 A TW103109012 A TW 103109012A TW 201521761 A TW201521761 A TW 201521761A
Authority
TW
Taiwan
Prior art keywords
rfviii
ppm
peg
formulation
bdd
Prior art date
Application number
TW103109012A
Other languages
English (en)
Chinese (zh)
Inventor
Deqian Wang
Xing-Hang Ma
Nelly Tsvetkova
Original Assignee
Bayer Healthcare 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 Bayer Healthcare Llc filed Critical Bayer Healthcare Llc
Publication of TW201521761A publication Critical patent/TW201521761A/zh

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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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/50Medicinal 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
    • 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
    • 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
    • C07K14/745Blood coagulation or fibrinolysis factors
    • C07K14/755Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Toxicology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
TW103109012A 2013-03-15 2014-03-13 重組體fviii調配物 TW201521761A (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361799495P 2013-03-15 2013-03-15
US201361869191P 2013-08-23 2013-08-23

Publications (1)

Publication Number Publication Date
TW201521761A true TW201521761A (zh) 2015-06-16

Family

ID=51580768

Family Applications (1)

Application Number Title Priority Date Filing Date
TW103109012A TW201521761A (zh) 2013-03-15 2014-03-13 重組體fviii調配物

Country Status (17)

Country Link
US (1) US20160030524A1 (https=)
EP (1) EP2970430A4 (https=)
JP (1) JP2016518321A (https=)
KR (1) KR20150132449A (https=)
CN (1) CN105209487A (https=)
AU (1) AU2014237111B2 (https=)
BR (1) BR112015022730A2 (https=)
CA (1) CA2905739A1 (https=)
HK (1) HK1213273A1 (https=)
MX (1) MX2015012905A (https=)
PE (1) PE20160121A1 (https=)
RU (1) RU2015144076A (https=)
SG (2) SG10201803999UA (https=)
TW (1) TW201521761A (https=)
UY (1) UY35412A (https=)
WO (1) WO2014150477A1 (https=)
ZA (1) ZA201507684B (https=)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190064147A1 (en) * 2015-01-18 2019-02-28 Biogen Ma Inc. Formulations and screening of biological therapeutic agents
EA202190827A1 (ru) 2015-11-13 2021-11-30 Баксалта Инкорпорейтед Вирусные векторы, кодирующие рекомбинантные варианты fviii с повышенной экспрессией для генной терапии гемофилии a
US12091675B2 (en) 2018-07-16 2024-09-17 Takeda Pharmaceutical Company Limited Gene therapy of hemophilia a using viral vectors encoding recombinant FVIII variants with increased expression
TWI851647B (zh) 2019-01-16 2024-08-11 日商武田藥品工業股份有限公司 用於a型血友病基因治療之編碼表現增加之重組fviii變異體的病毒載體
US20220305089A1 (en) * 2019-08-16 2022-09-29 Octapharma Ag Stabilizing buffer for factor viii and vwf

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5763401A (en) * 1996-07-12 1998-06-09 Bayer Corporation Stabilized albumin-free recombinant factor VIII preparation having a low sugar content
KR20010101901A (ko) * 1999-02-01 2001-11-15 모리 데쯔지 음극선관 및 그 제조방법
DK1820516T3 (da) * 1999-02-22 2013-10-28 Univ Connecticut Nye albuminfrie faktor VIII-præparater
ES2331909T3 (es) * 2001-06-14 2010-01-20 The Scripps Research Institute Factor viii estabilizado con enlaces disulfuro modificados geneticamente.
GB0207092D0 (en) * 2002-03-26 2002-05-08 Sod Conseils Rech Applic Stable pharmaceutical composition containing factor VIII
PT2363414T (pt) * 2004-11-12 2022-08-04 Bayer Healthcare Llc Modificação de fviii direcionada a sítio
AU2007245190B2 (en) * 2006-03-31 2011-07-21 Takeda Pharmaceutical Company Limited Pegylated factor VIII
MX339060B (es) * 2008-11-07 2016-05-09 Baxter Int Formulaciones del factor viii.
US20120121613A1 (en) * 2009-01-19 2012-05-17 Bayer Healthcare Llc Protein conjugate having an endopeptidase- cleavable bioprotective moiety

Also Published As

Publication number Publication date
BR112015022730A2 (pt) 2017-10-31
AU2014237111B2 (en) 2018-06-21
PE20160121A1 (es) 2016-03-03
EP2970430A4 (en) 2017-01-11
US20160030524A1 (en) 2016-02-04
AU2014237111A1 (en) 2015-10-08
EP2970430A1 (en) 2016-01-20
SG10201803999UA (en) 2018-06-28
CN105209487A (zh) 2015-12-30
MX2015012905A (es) 2016-06-16
HK1213273A1 (zh) 2016-06-30
ZA201507684B (en) 2017-06-28
JP2016518321A (ja) 2016-06-23
CA2905739A1 (en) 2014-09-25
SG11201507618YA (en) 2015-10-29
RU2015144076A (ru) 2017-04-24
UY35412A (es) 2014-10-31
WO2014150477A1 (en) 2014-09-25
KR20150132449A (ko) 2015-11-25

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