CN112955180A - 含有抗pcsk9抗体的稳定制剂 - Google Patents

含有抗pcsk9抗体的稳定制剂 Download PDF

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Publication number
CN112955180A
CN112955180A CN201980071607.XA CN201980071607A CN112955180A CN 112955180 A CN112955180 A CN 112955180A CN 201980071607 A CN201980071607 A CN 201980071607A CN 112955180 A CN112955180 A CN 112955180A
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China
Prior art keywords
antibody
amino acid
acid sequence
formulation
histidine
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Pending
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CN201980071607.XA
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English (en)
Inventor
刘洪川
刘沛想
张静
丁申皓
张梅
吴纯
冯辉
武海
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Shanghai Junshi Biosciences Co Ltd
Suzhou Junmeng Biosciences Co Ltd
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Shanghai Junshi Biosciences Co Ltd
Suzhou Junmeng Biosciences Co Ltd
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Publication of CN112955180A publication Critical patent/CN112955180A/zh
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    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IGs], 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • 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

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  • 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)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Obesity (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Microbiology (AREA)
  • Diabetes (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

一种含高浓度的抗PCSK9(人类前蛋白转化酶枯草溶菌素9)抗体的液体制剂，该制剂还包含一种缓冲液、一种稳定剂和一种表面活性剂。所述液体制剂具有低粘度，并且制剂在储存数月之后，抗体具有高稳定性。

Description

PCT国内申请，说明书已公开。

Claims (15)

  1. PCT国内申请，权利要求书已公开。
CN201980071607.XA 2018-10-31 2019-10-30 含有抗pcsk9抗体的稳定制剂 Pending CN112955180A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN2018112834407 2018-10-31
CN201811283440.7A CN111110841A (zh) 2018-10-31 2018-10-31 含有抗pcsk9抗体的稳定制剂
PCT/CN2019/114233 WO2020088492A1 (zh) 2018-10-31 2019-10-30 含有抗pcsk9抗体的稳定制剂

Publications (1)

Publication Number Publication Date
CN112955180A true CN112955180A (zh) 2021-06-11

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CN201811283440.7A Pending CN111110841A (zh) 2018-10-31 2018-10-31 含有抗pcsk9抗体的稳定制剂
CN201980071607.XA Pending CN112955180A (zh) 2018-10-31 2019-10-30 含有抗pcsk9抗体的稳定制剂

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US (1) US20210393777A1 (zh)
EP (1) EP3878467A4 (zh)
JP (1) JP2022519796A (zh)
KR (1) KR20210096105A (zh)
CN (2) CN111110841A (zh)
WO (1) WO2020088492A1 (zh)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024002357A1 (zh) * 2022-06-30 2024-01-04 康融东方（广东）医药有限公司 抗pcsk9抗体的制剂及其应用

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102245641A (zh) * 2008-12-15 2011-11-16 瑞泽恩制药公司 抗pcsk9的高亲和力人抗体
US20130189277A1 (en) * 2011-07-28 2013-07-25 Regeneron Pharmaceuticals, Inc. Stabilized Formulations Containing Anti-PCSK9 Antibodies
CN104619340A (zh) * 2012-05-03 2015-05-13 安姆根有限公司 含有抗pcsk9抗体的稳定制剂
WO2017088782A1 (zh) * 2015-11-27 2017-06-01 上海君实生物医药科技股份有限公司 抗pcsk9抗体及其应用

Family Cites Families (5)

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Publication number Priority date Publication date Assignee Title
US6659982B2 (en) 2000-05-08 2003-12-09 Sterling Medivations, Inc. Micro infusion drug delivery device
US6629949B1 (en) 2000-05-08 2003-10-07 Sterling Medivations, Inc. Micro infusion drug delivery device
MY165614A (en) * 2009-11-20 2018-04-18 Biocon Ltd Formulations of antibody
JP2013520476A (ja) * 2010-02-26 2013-06-06 ノヴォ ノルディスク アー／エス 安定な抗体含有組成物
KR20200035496A (ko) * 2015-09-22 2020-04-03 화이자 인코포레이티드 치료학적 단백질 제형의 제조 방법 및 이러한 방법에 의해 생산된 항체 제형

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102245641A (zh) * 2008-12-15 2011-11-16 瑞泽恩制药公司 抗pcsk9的高亲和力人抗体
US20130189277A1 (en) * 2011-07-28 2013-07-25 Regeneron Pharmaceuticals, Inc. Stabilized Formulations Containing Anti-PCSK9 Antibodies
CN103717237A (zh) * 2011-07-28 2014-04-09 瑞泽恩制药公司 含有抗pcsk9抗体的稳定配制剂
CN104619340A (zh) * 2012-05-03 2015-05-13 安姆根有限公司 含有抗pcsk9抗体的稳定制剂
WO2017088782A1 (zh) * 2015-11-27 2017-06-01 上海君实生物医药科技股份有限公司 抗pcsk9抗体及其应用
CN106810609A (zh) * 2015-11-27 2017-06-09 苏州君盟生物医药科技有限公司 抗pcsk9抗体及其应用

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024002357A1 (zh) * 2022-06-30 2024-01-04 康融东方（广东）医药有限公司 抗pcsk9抗体的制剂及其应用

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Publication number Publication date
JP2022519796A (ja) 2022-03-25
KR20210096105A (ko) 2021-08-04
CN111110841A (zh) 2020-05-08
WO2020088492A1 (zh) 2020-05-07
EP3878467A4 (en) 2022-08-10
EP3878467A1 (en) 2021-09-15
US20210393777A1 (en) 2021-12-23

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