JP2022514835A - インスリン及びグルカゴンを含む薬学組成物 - Google Patents

インスリン及びグルカゴンを含む薬学組成物 Download PDF

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JP2022514835A
JP2022514835A JP2021534266A JP2021534266A JP2022514835A JP 2022514835 A JP2022514835 A JP 2022514835A JP 2021534266 A JP2021534266 A JP 2021534266A JP 2021534266 A JP2021534266 A JP 2021534266A JP 2022514835 A JP2022514835 A JP 2022514835A
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cysteine
insulin
amino acid
acid
glucagon
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JP2022514835A5 (OSRAM
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ジョンクク キム
ジョンスク リー
ジョヨン ドン
エイ ラム リー
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ハンミ ファーマシューティカル カンパニー リミテッド
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Publication of JP2022514835A5 publication Critical patent/JP2022514835A5/ja
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    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 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
    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/28—Insulins
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/605—Glucagons
    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/26—Glucagons
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—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 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
    • A61K47/59—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 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
    • A61K47/60—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 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
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 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
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/62—Insulins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Endocrinology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Toxicology (AREA)
  • Obesity (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (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)
JP2021534266A 2018-12-21 2019-12-23 インスリン及びグルカゴンを含む薬学組成物 Pending JP2022514835A (ja)

Priority Applications (1)

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JP2024147410A JP2024178193A (ja) 2018-12-21 2024-08-29 インスリン及びグルカゴンを含む薬学組成物

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

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JP2024147410A Division JP2024178193A (ja) 2018-12-21 2024-08-29 インスリン及びグルカゴンを含む薬学組成物

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JP2022514835A true JP2022514835A (ja) 2022-02-16
JP2022514835A5 JP2022514835A5 (OSRAM) 2023-01-06

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JP2021534266A Pending JP2022514835A (ja) 2018-12-21 2019-12-23 インスリン及びグルカゴンを含む薬学組成物
JP2024147410A Pending JP2024178193A (ja) 2018-12-21 2024-08-29 インスリン及びグルカゴンを含む薬学組成物

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

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7596268B2 (ja) * 2018-12-21 2024-12-09 ハンミ ファーマシューティカル カンパニー リミテッド グルカゴン、glp-1及びgip受容体の全てに活性を有する三重活性体と、インスリンとを含む薬学組成物
CN116096397A (zh) * 2020-07-15 2023-05-09 韩美药品株式会社 胰高血糖素衍生物或其缀合物对于肝脏疾病的治疗用途

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006514990A (ja) * 2002-12-27 2006-05-18 ディオベックス, インコーポレイテッド インスリン誘発性低血糖の予防および制御のための組成物および方法
WO2018004283A2 (ko) * 2016-06-29 2018-01-04 한미약품 주식회사 글루카곤 유도체, 이의 결합체, 및 이를 포함하는 조성물, 및 이의 치료적 용도
WO2018144867A1 (en) * 2017-02-03 2018-08-09 Vanderbilt University Systems, compositions and methods for treating diabetes
JP2018528234A (ja) * 2015-09-24 2018-09-27 ハンミ ファーマシューティカル カンパニー リミテッド 免疫グロブリン断片の特定位置を連結部位として用いたタンパク質結合体
JP2018531237A (ja) * 2015-09-25 2018-10-25 ハンミ ファーマシューティカル カンパニー リミテッド 多数の生理活性ポリペプチド及び免疫グロブリンFc領域を含む、タンパク質結合体

Family Cites Families (12)

* 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
ATE279947T1 (de) 1996-03-18 2004-11-15 Univ Texas Immunglobulinähnliche domäne mit erhöhten halbwertszeiten
AR081066A1 (es) * 2010-04-02 2012-06-06 Hanmi Holdings Co Ltd Conjugado de insulina donde se usa un fragmento de inmunoglobulina
SG192038A1 (en) * 2011-01-20 2013-08-30 Zealand Pharma As Combination of acylated glucagon analogues with insulin analogues
SG10201907106VA (en) 2013-02-26 2019-09-27 Hanmi Pharmaceutical Co Ltd Novel insulin analog and use thereof
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
EP3151855B1 (en) 2014-06-08 2021-11-24 REMD Biotherapeutics, Inc. Methods for treating type 1 diabetes using glucagon receptor antagonistic antibodies
CR20170293A (es) 2014-12-30 2017-11-03 Hanmi Pharm Ind Co Ltd Derivados de glucagón con estabilidad mejorada
TN2017000555A1 (en) * 2015-06-30 2019-04-12 Hanmi Pharm Ind 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
AU2018215840A1 (en) * 2017-02-03 2019-08-01 Hanmi Pharm. Co., Ltd. Long-Acting Conjugate Of A Physiologically Active Material And Use Thereof
GB201710822D0 (en) * 2017-07-05 2017-08-16 Zealand Pharma As Methods and medical uses relating to the treatment of hypoglycaemia

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006514990A (ja) * 2002-12-27 2006-05-18 ディオベックス, インコーポレイテッド インスリン誘発性低血糖の予防および制御のための組成物および方法
JP2018528234A (ja) * 2015-09-24 2018-09-27 ハンミ ファーマシューティカル カンパニー リミテッド 免疫グロブリン断片の特定位置を連結部位として用いたタンパク質結合体
JP2018531237A (ja) * 2015-09-25 2018-10-25 ハンミ ファーマシューティカル カンパニー リミテッド 多数の生理活性ポリペプチド及び免疫グロブリンFc領域を含む、タンパク質結合体
WO2018004283A2 (ko) * 2016-06-29 2018-01-04 한미약품 주식회사 글루카곤 유도체, 이의 결합체, 및 이를 포함하는 조성물, 및 이의 치료적 용도
WO2018144867A1 (en) * 2017-02-03 2018-08-09 Vanderbilt University Systems, compositions and methods for treating diabetes

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
BIODRUGS, vol. 29, JPN6024043741, 2015, pages 215 - 239, ISSN: 0005446103 *
MED. CHEM. COMMUN., vol. 1, JPN6024043740, 2010, pages 319 - 324, ISSN: 0005446102 *

Also Published As

Publication number Publication date
JP2024178193A (ja) 2024-12-24
EP3900734A4 (en) 2022-10-12
CA3124340A1 (en) 2020-06-25
MX2021007124A (es) 2021-08-11
AU2019405389B2 (en) 2025-06-05
WO2020130751A1 (ko) 2020-06-25
AU2019405389A1 (en) 2021-06-24
EP3900734A1 (en) 2021-10-27
BR112021011557A2 (pt) 2021-09-14
US20220064248A1 (en) 2022-03-03
CN113365651A (zh) 2021-09-07
KR20200078414A (ko) 2020-07-01

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