CN115297838A - 抗内皮脂肪酶抗体的制剂 - Google Patents

抗内皮脂肪酶抗体的制剂 Download PDF

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Publication number
CN115297838A
CN115297838A CN202180016623.6A CN202180016623A CN115297838A CN 115297838 A CN115297838 A CN 115297838A CN 202180016623 A CN202180016623 A CN 202180016623A CN 115297838 A CN115297838 A CN 115297838A
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CN
China
Prior art keywords
pharmaceutical formulation
antibody
endothelial lipase
specifically binds
seq
Prior art date
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.)
Pending
Application number
CN202180016623.6A
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English (en)
Chinese (zh)
Inventor
S.M.帕特尔
S.K.潘萨雷
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Medium Medical Immunology Co ltd
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Medium Medical Immunology Co ltd
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Filing date
Publication date
Application filed by Medium Medical Immunology Co ltd filed Critical Medium Medical Immunology Co ltd
Publication of CN115297838A publication Critical patent/CN115297838A/zh
Pending legal-status Critical Current

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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
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Cardiology (AREA)
  • Immunology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
CN202180016623.6A 2020-02-24 2021-02-23 抗内皮脂肪酶抗体的制剂 Pending CN115297838A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202062980658P 2020-02-24 2020-02-24
US62/980,658 2020-02-24
PCT/US2021/019213 WO2021173537A1 (en) 2020-02-24 2021-02-23 Formulations of anti-endothelial lipase antibodies

Publications (1)

Publication Number Publication Date
CN115297838A true CN115297838A (zh) 2022-11-04

Family

ID=77492003

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202180016623.6A Pending CN115297838A (zh) 2020-02-24 2021-02-23 抗内皮脂肪酶抗体的制剂

Country Status (8)

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US (1) US20230131324A1 (cg-RX-API-DMAC10.html)
EP (1) EP4110290A4 (cg-RX-API-DMAC10.html)
JP (1) JP7892560B2 (cg-RX-API-DMAC10.html)
CN (1) CN115297838A (cg-RX-API-DMAC10.html)
AU (1) AU2021227871A1 (cg-RX-API-DMAC10.html)
CA (1) CA3211692A1 (cg-RX-API-DMAC10.html)
TW (1) TWI887362B (cg-RX-API-DMAC10.html)
WO (1) WO2021173537A1 (cg-RX-API-DMAC10.html)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102258464A (zh) * 2003-04-04 2011-11-30 健泰科生物技术公司 高浓度抗体和蛋白制剂
CN104768578A (zh) * 2012-10-25 2015-07-08 米迪缪尼有限公司 稳定的低粘度抗体配制品
US20150284471A1 (en) * 2011-12-08 2015-10-08 Amgen Inc Human LCAT Antigen Binding Proteins and Their Use in Therapy
CN106604744A (zh) * 2014-09-03 2017-04-26 免疫医疗有限公司 稳定的抗IL‑4R‑α抗体配制品
CN107074963A (zh) * 2014-09-11 2017-08-18 盐野义制药株式会社 抑制血管内皮脂肪酶的酶活性的人源化单克隆抗体

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7507808B2 (en) * 2002-12-12 2009-03-24 Isis Pharmaceuticals, Inc. Modulation of endothelial lipase expression
SMP200800064B (it) * 2006-04-21 2009-11-06 Novartis Ag Composizioni farmaceutiche di anticorpi anti-cd40 antagonista
PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
PE20120359A1 (es) 2009-03-06 2012-04-13 Genentech Inc Formulacion con anticuerpo
WO2012076670A2 (en) * 2010-12-10 2012-06-14 Novartis Ag Antibody formulation
US9932591B2 (en) * 2013-12-18 2018-04-03 University Of Delaware Reduction of lipase activity in product formulations
JP7377596B2 (ja) * 2017-02-22 2023-11-10 アムジエン・インコーポレーテツド 低粘度、高濃度エボロクマブ製剤及びそれらの製造方法

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102258464A (zh) * 2003-04-04 2011-11-30 健泰科生物技术公司 高浓度抗体和蛋白制剂
US20150284471A1 (en) * 2011-12-08 2015-10-08 Amgen Inc Human LCAT Antigen Binding Proteins and Their Use in Therapy
CN104768578A (zh) * 2012-10-25 2015-07-08 米迪缪尼有限公司 稳定的低粘度抗体配制品
CN106604744A (zh) * 2014-09-03 2017-04-26 免疫医疗有限公司 稳定的抗IL‑4R‑α抗体配制品
CN107074963A (zh) * 2014-09-11 2017-08-18 盐野义制药株式会社 抑制血管内皮脂肪酶的酶活性的人源化单克隆抗体

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
HU YUE等: "Characterization of Excipient Effects on Reversible Self-Association, Backbone Flexibility, and Solution Properties of an IgG1 Monoclonal Antibody at High Concentrations: Part 1", 《JOURNAL OF PHARMACEUTICAL SCIENCES》, vol. 109, no. 01, 13 June 2019 (2019-06-13), pages 340 *
JOHN E.LELAY等: "Blocking endothelial lipase with monoclonal antibody MEDI5884 durably increases high density lipoprotein in nonhuman primates and in a phase 1 trial", 《SCIENCE TRANSLATIONAL, vol. 13, no. 590, 21 April 2021 (2021-04-21), pages 0602, XP093149138, DOI: 10.1126/scitranslmed.abb0602 *

Also Published As

Publication number Publication date
AU2021227871A1 (en) 2022-09-15
TW202146046A (zh) 2021-12-16
JP7892560B2 (ja) 2026-07-21
EP4110290A4 (en) 2024-06-05
TWI887362B (zh) 2025-06-21
JP2023514721A (ja) 2023-04-07
US20230131324A1 (en) 2023-04-27
EP4110290A1 (en) 2023-01-04
WO2021173537A1 (en) 2021-09-02
CA3211692A1 (en) 2023-09-02

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