JP7827315B2 - 新生児における使用に好適な組成物 - Google Patents

新生児における使用に好適な組成物

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Publication number
JP7827315B2
JP7827315B2 JP2023548542A JP2023548542A JP7827315B2 JP 7827315 B2 JP7827315 B2 JP 7827315B2 JP 2023548542 A JP2023548542 A JP 2023548542A JP 2023548542 A JP2023548542 A JP 2023548542A JP 7827315 B2 JP7827315 B2 JP 7827315B2
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JP
Japan
Prior art keywords
composition
weeks
months
igf
micrograms
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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
JP2023548542A
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English (en)
Japanese (ja)
Other versions
JP2023550203A (ja
JP2023550203A5 (cg-RX-API-DMAC10.html
Inventor
サラマット-ミラー,ナジラ
テイラー,キャサリン
ヘ,ビング
バタチャリア,インドラニル
ハン,リンダ
アムスデン,ベニタ
クランツ,ジェームス
Original Assignee
オーク ヒル バイオ リミテッド
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Publication of JP2023550203A publication Critical patent/JP2023550203A/ja
Publication of JP2023550203A5 publication Critical patent/JP2023550203A5/ja
Priority to JP2026024189A priority Critical patent/JP2026102579A/ja
Application granted granted Critical
Publication of JP7827315B2 publication Critical patent/JP7827315B2/ja
Active legal-status Critical Current
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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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • A61K38/1754—Insulin-like growth factor binding proteins
    • 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
    • A61K38/30—Insulin-like growth factors, i.e. somatomedins, e.g. IGF-1, IGF-2
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Neurosurgery (AREA)
  • Pulmonology (AREA)
  • Dermatology (AREA)
  • Cardiology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
JP2023548542A 2020-10-19 2021-10-19 新生児における使用に好適な組成物 Active JP7827315B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2026024189A JP2026102579A (ja) 2020-10-19 2026-02-18 新生児における使用に好適な組成物

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202063093696P 2020-10-19 2020-10-19
US63/093,696 2020-10-19
PCT/US2021/055598 WO2022086953A1 (en) 2020-10-19 2021-10-19 Compositions suitable for use in neonates

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2026024189A Division JP2026102579A (ja) 2020-10-19 2026-02-18 新生児における使用に好適な組成物

Publications (3)

Publication Number Publication Date
JP2023550203A JP2023550203A (ja) 2023-11-30
JP2023550203A5 JP2023550203A5 (cg-RX-API-DMAC10.html) 2024-09-30
JP7827315B2 true JP7827315B2 (ja) 2026-03-10

Family

ID=78622033

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2023548542A Active JP7827315B2 (ja) 2020-10-19 2021-10-19 新生児における使用に好適な組成物
JP2026024189A Pending JP2026102579A (ja) 2020-10-19 2026-02-18 新生児における使用に好適な組成物

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2026024189A Pending JP2026102579A (ja) 2020-10-19 2026-02-18 新生児における使用に好適な組成物

Country Status (24)

Country Link
US (1) US20230381285A1 (cg-RX-API-DMAC10.html)
EP (2) EP4228676B1 (cg-RX-API-DMAC10.html)
JP (2) JP7827315B2 (cg-RX-API-DMAC10.html)
KR (1) KR20230113287A (cg-RX-API-DMAC10.html)
CN (1) CN117098547A (cg-RX-API-DMAC10.html)
AU (1) AU2021364523A1 (cg-RX-API-DMAC10.html)
CA (1) CA3194764A1 (cg-RX-API-DMAC10.html)
DK (1) DK4228676T3 (cg-RX-API-DMAC10.html)
ES (1) ES3005966T3 (cg-RX-API-DMAC10.html)
FI (1) FI4228676T3 (cg-RX-API-DMAC10.html)
HR (1) HRP20250193T1 (cg-RX-API-DMAC10.html)
HU (1) HUE070409T2 (cg-RX-API-DMAC10.html)
IL (1) IL301688A (cg-RX-API-DMAC10.html)
LT (1) LT4228676T (cg-RX-API-DMAC10.html)
MX (1) MX2023004426A (cg-RX-API-DMAC10.html)
PL (1) PL4228676T3 (cg-RX-API-DMAC10.html)
PT (1) PT4228676T (cg-RX-API-DMAC10.html)
RS (1) RS66493B1 (cg-RX-API-DMAC10.html)
SA (1) SA523440271B1 (cg-RX-API-DMAC10.html)
SI (1) SI4228676T1 (cg-RX-API-DMAC10.html)
SM (1) SMT202500093T1 (cg-RX-API-DMAC10.html)
TW (1) TWI912393B (cg-RX-API-DMAC10.html)
WO (1) WO2022086953A1 (cg-RX-API-DMAC10.html)
ZA (1) ZA202303162B (cg-RX-API-DMAC10.html)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20250099541A1 (en) 2022-01-19 2025-03-27 Oak Hill Bio Ltd Compositions and methods for reducing oxidation of igf-1/igfbp
CA3248280A1 (en) 2022-05-04 2023-11-09 Oak Hill Bio Limited POLYTHERAPY FOR PREMATURE INFANTS
WO2023242439A1 (en) * 2022-06-17 2023-12-21 Oak Hill Bio Limited Vascular stabilisation (preterm infants)
WO2023242440A1 (en) * 2022-06-17 2023-12-21 Oak Hill Bio Limited Treament of lungs in infants
EP4598630A1 (en) * 2022-10-04 2025-08-13 Oak Hill Bio Limited Method of treating neonates with igf-1 complex

Family Cites Families (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL71991A (en) 1983-06-06 1994-05-30 Genentech Inc Preparation of human FGI and FGE in their processed form through recombinant AND tranology in prokaryotes
ATE90690T1 (de) 1987-04-06 1993-07-15 Celtrix Pharma Menschliche somatomedin-traeger-proteinuntereinheiten und verfahren zu ihrer herstellung.
DK131988A (da) 1988-03-11 1989-09-12 Erasmus University Igf-bindingsprotein, dna-struktur, der koder for igf-bindingsproteinet og vektor indeholdende denne dna-struktur
US5258287A (en) 1988-03-22 1993-11-02 Genentech, Inc. DNA encoding and methods of production of insulin-like growth factor binding protein BP53
ATE132164T1 (de) 1988-04-12 1996-01-15 Amgen Boulder Inc Verfahren zur steigerung und zur hemmung der wirkung eines insulinähnlichen wachstumfaktors
GB8826451D0 (en) 1988-11-11 1988-12-14 Sandoz Ltd Improvements in/relating to organic compounds
IL92816A0 (en) 1988-12-22 1990-09-17 Biogrowth Inc Recombinant dna molecules,hosts,processes and human somatomedin carrier protein-like polypeptides
EP0639981A4 (en) 1992-05-08 1995-06-28 Univ Jefferson ANALOGS OF THE IGF FACTOR (01/18/94).
US5563046A (en) 1993-08-02 1996-10-08 Celtrix Pharmaceuticals, Inc. Fusion polypeptides and proteins
US5789547A (en) 1995-06-07 1998-08-04 Celtrix Pharmaceuticals, Inc. Method of producing insulin-like growth factor-I (IGF-I) and insulin-like growth factor binding protein-3 (IGFBP-3) with correct folding and disulfide bonding
US5783556A (en) * 1996-08-13 1998-07-21 Genentech, Inc. Formulated insulin-containing composition
EP0956041A1 (en) * 1996-09-16 1999-11-17 Dalhousie University Use of igf-i for the treatment of polycystic kidney disease and related indications
US6121416A (en) 1997-04-04 2000-09-19 Genentech, Inc. Insulin-like growth factor agonist molecules
US6436897B2 (en) * 1998-06-01 2002-08-20 Celtrix Pharmaceuticals, Inc. Pharmaceutical formulations for IGF/IGFBP
US20020028764A1 (en) * 2000-09-04 2002-03-07 Aarhus Amt. Treatment of acute and chronic liver disease
JP2008543839A (ja) * 2005-06-14 2008-12-04 アムジェン インコーポレーテッド 自己緩衝タンパク質製剤
RU2558821C2 (ru) * 2009-11-17 2015-08-10 Ипсен Фарма С.А.С. ЛЕКАРСТВЕННАЯ ФОРМА ДЛЯ КОМБИНАЦИИ hGH И rhIGF-1
US20110152188A1 (en) * 2009-12-23 2011-06-23 Hanns-Christian Mahler Pharmaceutical compositions of igf/i proteins
CA2897062A1 (en) * 2013-01-15 2014-07-24 Teva Pharmaceutical Industries Ltd. Lyophilization process
KR20140119396A (ko) * 2013-03-29 2014-10-10 삼성전자주식회사 단백질 약물의 액상 제형
EP3681602B1 (en) * 2017-09-11 2026-04-15 Oak Hill Bio Limited Compositions for reducing the incidence of bpd
US20250099541A1 (en) * 2022-01-19 2025-03-27 Oak Hill Bio Ltd Compositions and methods for reducing oxidation of igf-1/igfbp
WO2023139250A1 (en) * 2022-01-24 2023-07-27 Oak Hill Bio Limited Lot release assays for igf‐1/igfbp complexes

Also Published As

Publication number Publication date
PT4228676T (pt) 2025-01-24
JP2026102579A (ja) 2026-06-23
SMT202500093T1 (it) 2025-03-12
IL301688A (en) 2023-05-01
WO2022086953A9 (en) 2022-07-07
AU2021364523A1 (en) 2023-04-06
JP2023550203A (ja) 2023-11-30
ES3005966T3 (en) 2025-03-17
MX2023004426A (es) 2023-08-04
LT4228676T (lt) 2025-02-10
CN117098547A (zh) 2023-11-21
HUE070409T2 (hu) 2025-06-28
HRP20250193T1 (hr) 2025-04-11
SA523440271B1 (ar) 2025-04-10
EP4534073A2 (en) 2025-04-09
EP4228676A1 (en) 2023-08-23
US20230381285A1 (en) 2023-11-30
SI4228676T1 (sl) 2025-03-31
WO2022086953A1 (en) 2022-04-28
TWI912393B (zh) 2026-01-21
KR20230113287A (ko) 2023-07-28
FI4228676T3 (fi) 2025-02-26
CA3194764A1 (en) 2022-04-28
EP4534073A3 (en) 2025-05-14
RS66493B1 (sr) 2025-03-31
DK4228676T3 (da) 2025-01-20
PL4228676T3 (pl) 2025-04-07
EP4228676B1 (en) 2025-01-08
ZA202303162B (en) 2024-08-28
TW202233228A (zh) 2022-09-01

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