CN110431153A - 一种pcsk-9抗体药物组合物及其用途 - Google Patents

一种pcsk-9抗体药物组合物及其用途 Download PDF

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Publication number
CN110431153A
CN110431153A CN201880019136.3A CN201880019136A CN110431153A CN 110431153 A CN110431153 A CN 110431153A CN 201880019136 A CN201880019136 A CN 201880019136A CN 110431153 A CN110431153 A CN 110431153A
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CN
China
Prior art keywords
antibody
pcsk
pharmaceutical composition
buffer
seq
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CN201880019136.3A
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CN110431153B (zh
Inventor
田晨敏
李皓
刘洵
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Guangdong Jiangsu Hengrui Medicine Co ltd
Jiangsu Hengrui Medicine Co Ltd
Shanghai Hengrui Pharmaceutical Co Ltd
Suzhou Suncadia Biopharmaceuticals Co Ltd
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Jiangsu Hengrui Medicine Co Ltd
Shanghai Hengrui Pharmaceutical Co Ltd
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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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K9/14—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
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • 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 [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
    • A61K2039/545—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
    • C07K2317/20—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
    • C07K2317/90—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

Abstract

本发明提供了一种药物组合物，其包含在组氨酸缓冲液中的PCSK9抗体或其抗原结合片段。除此之外，该药物组合物还可含有糖和非离子型表面活性剂。

Description

PCT国内申请，说明书已公开。

Claims (28)

  1. PCT国内申请，权利要求书已公开。
CN201880019136.3A 2017-06-30 2018-06-29 一种pcsk-9抗体药物组合物及其用途 Active CN110431153B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN2017105198296 2017-06-30
CN201710519829 2017-06-30
PCT/CN2018/093573 WO2019001560A1 (zh) 2017-06-30 2018-06-29 一种pcsk-9抗体药物组合物及其用途

Publications (2)

Publication Number Publication Date
CN110431153A true CN110431153A (zh) 2019-11-08
CN110431153B CN110431153B (zh) 2023-09-19

Family

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Country Status (8)

Country Link
US (1) US20200223941A1 (zh)
EP (1) EP3647325A4 (zh)
JP (1) JP2020532491A (zh)
CN (1) CN110431153B (zh)
AU (1) AU2018291702A1 (zh)
CA (1) CA3067953A1 (zh)
TW (1) TWI720325B (zh)
WO (1) WO2019001560A1 (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

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021185344A1 (zh) 2020-03-19 2021-09-23 江苏恒瑞医药股份有限公司 一种胆固醇相关疾病的治疗方法

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WO2011063277A1 (en) * 2009-11-20 2011-05-26 Amgen Inc. Anti-orai1 antigen binding proteins and uses thereof
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
WO2017114230A1 (zh) * 2015-12-31 2017-07-06 江苏恒瑞医药股份有限公司 Pcsk9抗体、其抗原结合片段及其医药用途
WO2017118307A1 (zh) * 2016-01-05 2017-07-13 江苏恒瑞医药股份有限公司 Pcsk9抗体、其抗原结合片段及其医药用途

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JOP20200043A1 (ar) * 2011-05-10 2017-06-16 Amgen Inc طرق معالجة أو منع الاضطرابات المختصة بالكوليسترول
WO2012168491A1 (en) * 2011-06-10 2012-12-13 Novartis Ag Pharmaceutical formulations of pcsk9 antagonists
CN104364266A (zh) 2012-06-15 2015-02-18 霍夫曼-拉罗奇有限公司 抗-pcsk9抗体,制剂,剂量给药,和使用方法
JP6271557B2 (ja) * 2012-09-21 2018-01-31 フィリップス ライティング ホールディング ビー ヴィ Ｄｃ配電システム
TWI682780B (zh) * 2013-05-30 2020-01-21 美商再生元醫藥公司 醫藥組成物用於製造治療與ｐｃｓｋ９功能獲得性突變有關之體染色體顯性高膽固醇血症的藥物之用途

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WO2011063277A1 (en) * 2009-11-20 2011-05-26 Amgen Inc. Anti-orai1 antigen binding proteins and uses thereof
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
WO2017114230A1 (zh) * 2015-12-31 2017-07-06 江苏恒瑞医药股份有限公司 Pcsk9抗体、其抗原结合片段及其医药用途
WO2017118307A1 (zh) * 2016-01-05 2017-07-13 江苏恒瑞医药股份有限公司 Pcsk9抗体、其抗原结合片段及其医药用途

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* 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

Also Published As

Publication number Publication date
RU2020102952A (ru) 2021-07-30
WO2019001560A1 (zh) 2019-01-03
EP3647325A4 (en) 2021-03-17
US20200223941A1 (en) 2020-07-16
AU2018291702A1 (en) 2020-02-06
TW201904609A (zh) 2019-02-01
RU2020102952A3 (zh) 2022-03-24
EP3647325A1 (en) 2020-05-06
CN110431153B (zh) 2023-09-19
CA3067953A1 (en) 2019-01-03
TWI720325B (zh) 2021-03-01
JP2020532491A (ja) 2020-11-12

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