BR112013010311A8 - formulações líquidas de interferon-alfa conjugado de longa ação prolongada - Google Patents

formulações líquidas de interferon-alfa conjugado de longa ação prolongada

Info

Publication number
BR112013010311A8
BR112013010311A8 BR112013010311A BR112013010311A BR112013010311A8 BR 112013010311 A8 BR112013010311 A8 BR 112013010311A8 BR 112013010311 A BR112013010311 A BR 112013010311A BR 112013010311 A BR112013010311 A BR 112013010311A BR 112013010311 A8 BR112013010311 A8 BR 112013010311A8
Authority
BR
Brazil
Prior art keywords
acting
long
liquid formulations
conjugated interferon
alpha liquid
Prior art date
Application number
BR112013010311A
Other languages
English (en)
Other versions
BR112013010311A2 (pt
Inventor
Seong Im Dae
Min Lee Jae
Soo Lee Jong
Chang Kwon Se
Min Bae Sung
Original Assignee
Hanmi Science Co 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 Hanmi Science Co Ltd filed Critical Hanmi Science Co Ltd
Publication of BR112013010311A2 publication Critical patent/BR112013010311A2/pt
Publication of BR112013010311A8 publication Critical patent/BR112013010311A8/pt

Links

Classifications

    • 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
    • C07K14/52Cytokines; Lymphokines; Interferons
    • C07K14/555Interferons [IFN]
    • C07K14/56IFN-alpha
    • 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
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/21Interferons [IFN]
    • A61K38/212IFN-alpha
    • 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
    • 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
    • A61K47/68Medicinal 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 antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • 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
    • A61K47/68Medicinal 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 antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • A61K47/6813Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin the drug being a peptidic cytokine, e.g. an interleukin or interferon
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/46Hybrid immunoglobulins
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/30Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Toxicology (AREA)
  • Virology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
BR112013010311A 2010-10-26 2011-10-26 formulações líquidas de interferon-alfa conjugado de longa ação prolongada BR112013010311A8 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020100104383A KR101303388B1 (ko) 2010-10-26 2010-10-26 지속형 인터페론 알파 결합체의 액상 제제
PCT/KR2011/008038 WO2012057525A2 (en) 2010-10-26 2011-10-26 Liquid formulations of long acting interferon alpha conjugate

Publications (2)

Publication Number Publication Date
BR112013010311A2 BR112013010311A2 (pt) 2016-09-20
BR112013010311A8 true BR112013010311A8 (pt) 2018-01-16

Family

ID=45994559

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112013010311A BR112013010311A8 (pt) 2010-10-26 2011-10-26 formulações líquidas de interferon-alfa conjugado de longa ação prolongada

Country Status (13)

Country Link
US (1) US9669105B2 (pt)
EP (1) EP2632433A4 (pt)
JP (1) JP6047495B2 (pt)
KR (1) KR101303388B1 (pt)
CN (2) CN103228265A (pt)
AR (1) AR083568A1 (pt)
AU (1) AU2011321165B2 (pt)
BR (1) BR112013010311A8 (pt)
CA (1) CA2816052C (pt)
MX (1) MX349441B (pt)
RU (1) RU2613905C2 (pt)
TW (1) TWI494120B (pt)
WO (1) WO2012057525A2 (pt)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8617568B2 (en) 2007-07-10 2013-12-31 Medy-Tox, Inc. Pharmaceutical liquid composition of botulinum toxin with improved stability
EP3434687B1 (en) 2011-06-10 2021-03-10 Hanmi Science Co., Ltd. Novel oxyntomodulin derivatives and pharmaceutical composition for treating obesity comprising the same
TR201901402T4 (tr) 2011-06-17 2019-02-21 Hanmi Science Co Ltd Oksintomodulin ve bir immünoglobulin fragmanı içeren bir konjugat ve onun kullanımı.
EP2753348B1 (en) * 2011-09-05 2019-12-11 Hanmi Science Co., Ltd. Pharmaceutical compositions comprising an interferon alpha conjugate and gemcitabine for the treatment of cancer
KR20130049671A (ko) 2011-11-04 2013-05-14 한미사이언스 주식회사 생리활성 폴리펩타이드 결합체 제조 방법
AR090281A1 (es) 2012-03-08 2014-10-29 Hanmi Science Co Ltd Proceso mejorado para la preparacion de un complejo polipeptidico fisiologicamente activo
AR091902A1 (es) * 2012-07-25 2015-03-11 Hanmi Pharm Ind Co Ltd Formulacion liquida de un conjugado de insulina de accion prolongada
KR101968344B1 (ko) 2012-07-25 2019-04-12 한미약품 주식회사 옥신토모듈린 유도체를 포함하는 고지혈증 치료용 조성물
AR092862A1 (es) * 2012-07-25 2015-05-06 Hanmi Pharm Ind Co Ltd Formulacion liquida de insulina de accion prolongada y un peptido insulinotropico y metodo de preparacion
AR094821A1 (es) * 2012-07-25 2015-09-02 Hanmi Pharm Ind Co Ltd Formulación líquida de un conjugado de péptido insulinotrópico de acción prolongada
US10441665B2 (en) 2012-07-25 2019-10-15 Hanmi Pharm. Co., Ltd. Liquid formulation of long acting insulinotropic peptide conjugate
KR101993393B1 (ko) 2012-11-06 2019-10-01 한미약품 주식회사 옥신토모듈린 유도체를 포함하는 당뇨병 또는 비만성 당뇨병 치료용 조성물
PH12018501454A1 (en) 2012-11-06 2020-02-17 Hanmi Pharm Ind Co Ltd Liquid formulation of protein conjugate comprising the oxyntomodulin and an immunoglubin fragment
KR102385120B1 (ko) * 2014-03-31 2022-04-12 한미약품 주식회사 면역글로불린 Fc 단편 결합을 이용한 단백질 및 펩타이드의 용해도를 개선시키는 방법
TWI802396B (zh) 2014-09-16 2023-05-11 南韓商韓美藥品股份有限公司 長效glp-1/高血糖素受體雙促效劑治療非酒精性脂肝疾病之用途
KR102418477B1 (ko) 2014-12-30 2022-07-08 한미약품 주식회사 글루카곤 유도체
TWI594762B (zh) * 2016-03-23 2017-08-11 Rui-Lin Gong Fish interferon nanocapsules encapsulated in chitosan-polylactic acid-polyglycolic acid copolymer by ultrasonic vibration method to effectively prevent its destruction in fish gastrointestinal tract

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US5766582A (en) * 1994-10-11 1998-06-16 Schering Corporation Stable, aqueous alfa interferon solution formulations
JP2758154B2 (ja) 1995-04-06 1998-05-28 エフ・ホフマン−ラ ロシユ アーゲー インターフェロンを含む液体製剤
US20050002902A1 (en) 1995-12-28 2005-01-06 Liming Yu Hybrid with interferon-alpha and an immunoglobulin Fc for treatment of tumors and viral infections
DK1017413T4 (da) * 1997-09-23 2008-03-25 Rentschler Biotech Gmbh Flydende formulering af interferon-beta
TWI243057B (en) * 1998-03-26 2005-11-11 Schering Corp Formulations for protection of peg-interferon alpha conjugates
KR19990085129A (ko) 1998-05-14 1999-12-06 성재갑 안정한 α-인터페론 용액 제제
CN1175901C (zh) 1999-12-06 2004-11-17 天津华立达生物工程有限公司 一种稳定的干扰素水溶液
US20030138403A1 (en) 2001-06-29 2003-07-24 Maxygen Aps Interferon formulations
US20030104996A1 (en) 2001-08-30 2003-06-05 Tiansheng Li L-methionine as a stabilizer for NESP/EPO in HSA-free formulations
US7737260B2 (en) * 2003-11-13 2010-06-15 Hanmi Pharm. Co., Ltd Protein complex using an immunoglobulin fragment and method for the preparation thereof
US7314613B2 (en) 2002-11-18 2008-01-01 Maxygen, Inc. Interferon-alpha polypeptides and conjugates
US20050176108A1 (en) * 2003-03-13 2005-08-11 Young-Min Kim Physiologically active polypeptide conjugate having prolonged in vivo half-life
EP1641486B1 (en) 2003-06-10 2012-04-18 LG Life Sciences Ltd. Stable, aqueous solution of human erythropoietin, not containing serum albumin
US8110665B2 (en) * 2003-11-13 2012-02-07 Hanmi Holdings Co., Ltd. Pharmaceutical composition comprising an immunoglobulin FC region as a carrier
KR100754667B1 (ko) * 2005-04-08 2007-09-03 한미약품 주식회사 비펩타이드성 중합체로 개질된 면역글로불린 Fc 단편 및이를 포함하는 약제학적 조성물
AU2006250068A1 (en) 2005-05-26 2006-11-30 Schering Corporation Interferon-IGG fusion
EP3673919A1 (en) 2005-06-14 2020-07-01 Amgen Inc. Self-buffering protein formulations
US20080071063A1 (en) * 2006-02-03 2008-03-20 Medimmune, Inc. Protein Formulations
JP2008050320A (ja) 2006-08-28 2008-03-06 Toray Ind Inc インターフェロン−β含有医薬組成物
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MX2011000861A (es) 2008-07-23 2011-06-21 Hanmi Holdings Co Ltd Un complejo polipeptidico que consiste en un polimero no-peptidil que posee tres terminaciones funcionales.
WO2011090306A2 (en) * 2010-01-19 2011-07-28 Hanmi Holdings Co., Ltd Liquid formulations for long-acting erythropoietin conjugate
BR112012017979B1 (pt) * 2010-01-19 2021-10-13 Hanmi Science Co., Ltd. Formulações líquidas para conjugado de g-csf de ação prolongada

Also Published As

Publication number Publication date
US20130287734A1 (en) 2013-10-31
CA2816052C (en) 2018-07-24
MX2013004595A (es) 2013-12-02
MX349441B (es) 2017-07-27
TW201223541A (en) 2012-06-16
CA2816052A1 (en) 2012-05-03
RU2013124059A (ru) 2014-12-10
BR112013010311A2 (pt) 2016-09-20
AR083568A1 (es) 2013-03-06
CN108283714A (zh) 2018-07-17
WO2012057525A3 (en) 2012-06-28
RU2613905C2 (ru) 2017-03-21
AU2011321165A1 (en) 2013-05-09
US9669105B2 (en) 2017-06-06
EP2632433A4 (en) 2014-04-16
TWI494120B (zh) 2015-08-01
AU2011321165B2 (en) 2015-11-05
JP2013544803A (ja) 2013-12-19
KR20120043206A (ko) 2012-05-04
EP2632433A2 (en) 2013-09-04
WO2012057525A2 (en) 2012-05-03
JP6047495B2 (ja) 2016-12-21
CN103228265A (zh) 2013-07-31
KR101303388B1 (ko) 2013-09-03

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B11B Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements
B350 Update of information on the portal [chapter 15.35 patent gazette]