BR112021011557A2 - Formulação complexa e composição farmacêutica incluindo insulina e glucagon - Google Patents

Formulação complexa e composição farmacêutica incluindo insulina e glucagon Download PDF

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Publication number
BR112021011557A2
BR112021011557A2 BR112021011557-9A BR112021011557A BR112021011557A2 BR 112021011557 A2 BR112021011557 A2 BR 112021011557A2 BR 112021011557 A BR112021011557 A BR 112021011557A BR 112021011557 A2 BR112021011557 A2 BR 112021011557A2
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BR
Brazil
Prior art keywords
cysteine
insulin
amino acid
glucagon
pharmaceutical composition
Prior art date
Application number
BR112021011557-9A
Other languages
English (en)
Portuguese (pt)
Inventor
Jung Kuk Kim
Jong Suk Lee
Joo Young DONG
A Ram LEE
Original Assignee
Hanmi Pharm. 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 Pharm. Co., Ltd. filed Critical Hanmi Pharm. Co., Ltd.
Publication of BR112021011557A2 publication Critical patent/BR112021011557A2/pt

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    • 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
    • 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
    • A61K38/22Hormones
    • A61K38/28Insulins
    • 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
    • C07K14/575Hormones
    • C07K14/605Glucagons
    • 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
    • A61K38/22Hormones
    • A61K38/26Glucagons
    • 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
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/04Anorexiants; Antiobesity agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • 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
    • C07K14/575Hormones
    • C07K14/62Insulins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • 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)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Endocrinology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Toxicology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Emergency Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
BR112021011557-9A 2018-12-21 2019-12-23 Formulação complexa e composição farmacêutica incluindo insulina e glucagon BR112021011557A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR10-2018-0167798 2018-12-21
KR20180167798 2018-12-21
PCT/KR2019/018320 WO2020130751A1 (ko) 2018-12-21 2019-12-23 인슐린 및 글루카곤을 포함하는 약학 조성물

Publications (1)

Publication Number Publication Date
BR112021011557A2 true BR112021011557A2 (pt) 2021-09-14

Family

ID=71102651

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112021011557-9A BR112021011557A2 (pt) 2018-12-21 2019-12-23 Formulação complexa e composição farmacêutica incluindo insulina e glucagon

Country Status (10)

Country Link
US (1) US20220064248A1 (https=)
EP (1) EP3900734A4 (https=)
JP (2) JP2022514835A (https=)
KR (1) KR20200078414A (https=)
CN (1) CN113365651A (https=)
AU (1) AU2019405389B2 (https=)
BR (1) BR112021011557A2 (https=)
CA (1) CA3124340A1 (https=)
MX (1) MX2021007124A (https=)
WO (1) WO2020130751A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113453703A (zh) * 2018-12-21 2021-09-28 韩美药品株式会社 包括胰岛素和对胰高血糖素和glp-1和gip受体均具有活性的三重激动剂的药物组合物
EP4183407A4 (en) * 2020-07-15 2024-08-14 Hanmi Pharm. Co., Ltd. THERAPEUTIC USE OF A GLUCAGNONE DERIVATIVE OR CONJUGATE THEREOF FOR LIVER DISEASES

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6096871A (en) 1995-04-14 2000-08-01 Genentech, Inc. Polypeptides altered to contain an epitope from the Fc region of an IgG molecule for increased half-life
JP4046354B2 (ja) 1996-03-18 2008-02-13 ボード オブ リージェンツ,ザ ユニバーシティ オブ テキサス システム 増大した半減期を有する免疫グロブリン様ドメイン
US7314859B2 (en) * 2002-12-27 2008-01-01 Diobex, Inc. Compositions and methods for the prevention and control of insulin-induced hypoglycemia
AR081066A1 (es) * 2010-04-02 2012-06-06 Hanmi Holdings Co Ltd Conjugado de insulina donde se usa un fragmento de inmunoglobulina
KR20140043709A (ko) * 2011-01-20 2014-04-10 질랜드 파마 에이/에스 아실화 글루카곤 유사체와 인슐린 유사체의 조합
DK2963056T3 (da) 2013-02-26 2020-02-17 Hanmi Pharm Ind Co Ltd Insulinanalog og anvendelse deraf
AR100695A1 (es) * 2014-05-30 2016-10-26 Hanmi Pharm Ind Co Ltd Composición para el tratamiento de diabetes mellitus que comprende insulina y un agonista dual glp-1 / glucagón
WO2015189698A2 (en) 2014-06-08 2015-12-17 Beijing Cosci-Remd Bio Med Tech Company Ltd Methods for treating type 1 diabetes using glucagon receptor antagonistic antibodies
PE20171154A1 (es) * 2014-12-30 2017-08-16 Hanmi Pharm Ind Co Ltd Derivados de glucagon con estabilidad mejorada
EP4523705A3 (en) * 2015-06-30 2025-06-11 Hanmi Pharm. Co., Ltd. Glucagon derivative and a composition comprising a long acting conjugate of the same
UY36870A (es) 2015-08-28 2017-03-31 Hanmi Pharm Ind Co Ltd Análogos de insulina novedosos
WO2017052329A1 (en) * 2015-09-24 2017-03-30 Hanmi Pharm. Co., Ltd. Protein complex by use of a specific site of an immunoglobulin fragment for linkage
TW201718629A (zh) * 2015-09-25 2017-06-01 韓美藥品股份有限公司 包含多個生理多肽及免疫球蛋白Fc區之蛋白質接合物
EP3479841A4 (en) * 2016-06-29 2020-03-04 Hanmi Pharm. Co., Ltd. GLUCAGON DERIVATIVE, CONJUGATE THEREOF, COMPOSITION THEREOF AND THERAPEUTIC USE THEREOF
WO2018144867A1 (en) * 2017-02-03 2018-08-09 Vanderbilt University Systems, compositions and methods for treating diabetes
CN110545849A (zh) * 2017-02-03 2019-12-06 韩美药品株式会社 具有增加的持续性的生理活性物质的缀合物及其应用
GB201710822D0 (en) * 2017-07-05 2017-08-16 Zealand Pharma As Methods and medical uses relating to the treatment of hypoglycaemia

Also Published As

Publication number Publication date
WO2020130751A1 (ko) 2020-06-25
CN113365651A (zh) 2021-09-07
AU2019405389A1 (en) 2021-06-24
US20220064248A1 (en) 2022-03-03
MX2021007124A (es) 2021-08-11
EP3900734A1 (en) 2021-10-27
JP2024178193A (ja) 2024-12-24
JP2022514835A (ja) 2022-02-16
CA3124340A1 (en) 2020-06-25
AU2019405389B2 (en) 2025-06-05
EP3900734A4 (en) 2022-10-12
KR20200078414A (ko) 2020-07-01

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