CN104364266A - 抗-pcsk9抗体,制剂,剂量给药,和使用方法 - Google Patents

抗-pcsk9抗体,制剂,剂量给药,和使用方法 Download PDF

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Publication number
CN104364266A
CN104364266A CN201380031599.9A CN201380031599A CN104364266A CN 104364266 A CN104364266 A CN 104364266A CN 201380031599 A CN201380031599 A CN 201380031599A CN 104364266 A CN104364266 A CN 104364266A
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CN
China
Prior art keywords
hvr
seq
antibody
amino acid
pcsk9
Prior art date
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Pending
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CN201380031599.9A
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English (en)
Chinese (zh)
Inventor
吴岩
塞西莉亚·培·芝·秋
丹尼尔·K·柯克霍弗
安德鲁·彼得森
加内什·A·科卢曼姆
莫妮卡·孔·贝尔特仑
保罗·莫兰
李蔚
克森·拉姆
林·路易斯
许令攸
惠特莫尔·廷利
约翰·道格拉斯·大卫
纳格什沃·R·布达
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F Hoffmann La Roche AG
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F Hoffmann La Roche AG
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Publication of CN104364266A publication Critical patent/CN104364266A/zh
Pending legal-status Critical Current

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    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'
    • 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)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Obesity (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
CN201380031599.9A 2012-06-15 2013-06-14 抗-pcsk9抗体,制剂,剂量给药,和使用方法 Pending CN104364266A (zh)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201261660605P 2012-06-15 2012-06-15
US61/660,605 2012-06-15
US201361786280P 2013-03-14 2013-03-14
US61/786,280 2013-03-14
PCT/US2013/046032 WO2013188855A1 (en) 2012-06-15 2013-06-14 Anti-pcsk9 antibodies, formulations, dosing, and methods of use

Publications (1)

Publication Number Publication Date
CN104364266A true CN104364266A (zh) 2015-02-18

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
CN201380031599.9A Pending CN104364266A (zh) 2012-06-15 2013-06-14 抗-pcsk9抗体,制剂,剂量给药,和使用方法

Country Status (13)

Country Link
US (2) US9266961B2 (enExample)
EP (1) EP2861624A1 (enExample)
JP (1) JP2015530867A (enExample)
KR (1) KR20150023711A (enExample)
CN (1) CN104364266A (enExample)
AR (1) AR091462A1 (enExample)
BR (1) BR112014031310A2 (enExample)
CA (1) CA2875096A1 (enExample)
HK (1) HK1205141A1 (enExample)
MX (1) MX2014014830A (enExample)
RU (1) RU2015101113A (enExample)
TW (1) TW201410706A (enExample)
WO (1) WO2013188855A1 (enExample)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107177003A (zh) * 2017-06-27 2017-09-19 上海海玫生物科技有限公司 一种特异性抗人pcsk9的抗体及其应用
WO2017174017A1 (zh) * 2016-04-07 2017-10-12 迈博斯（香港）科技有限公司 前蛋白转化酶枯草溶菌素kexin 9型的结合蛋白及其应用
WO2017211313A1 (zh) * 2016-06-08 2017-12-14 常州博嘉生物医药科技有限公司 长效pcsk9特异性的结合蛋白及其应用
WO2019001560A1 (zh) 2017-06-30 2019-01-03 江苏恒瑞医药股份有限公司 一种pcsk-9抗体药物组合物及其用途
CN109776680A (zh) * 2019-01-25 2019-05-21 浙江蓝盾药业有限公司 抗人pcsk9单克隆抗体及其用途

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JOP20080381B1 (ar) 2007-08-23 2023-03-28 Amgen Inc بروتينات مرتبطة بمولدات مضادات تتفاعل مع بروبروتين كونفيرتاز سيتيليزين ككسين من النوع 9 (pcsk9)
US9255154B2 (en) 2012-05-08 2016-02-09 Alderbio Holdings, Llc Anti-PCSK9 antibodies and use thereof
EP3169710A1 (en) * 2014-07-14 2017-05-24 Amgen Inc. Crystalline antibody formulations
CN105461809B (zh) * 2015-02-11 2018-10-12 康融东方（广东）医药有限公司 Pcsk9抗体、其药物组合物及其用途
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
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
CN107531795B (zh) * 2016-01-05 2021-01-19 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
BR112018076242A2 (pt) * 2016-06-24 2019-03-26 Hoffmann La Roche inibidores de pcsk9, pcsk9 inibido, composição farmacêutica, métodos para modular a atividade de pcsk9, para inibir a ligação de pcsk9 a ldlr, para aumentar a disponibilidade de ldlr, para reduzir um nível de ldl-c, para reduzir o nível sérico de ldl-c, para o tratamento de um distúrbio relacionado com colesterol, métodos para o tratamento de um distúrbio associado a um nível anormal de ldl-c, de uma condição associada a um nível elevado de ldl-c, de dislipidemia, de hipercolesterolemia, usos de um inibidor de pcsk9 e método para identificar um composto candidato como um inibidor de pcsk9 que liga um epítopo da seq id nº 1
EP3515949A4 (en) * 2016-09-20 2020-10-28 Wuxi Biologics Ireland Limited. NEW ANTI-PCSK9 ANTIBODIES
CN107698679B (zh) * 2017-01-22 2019-03-01 北京东方百泰生物科技有限公司 抗pcsk9单克隆抗体
US11325945B2 (en) 2017-04-12 2022-05-10 Cadila Healthcare Limited Peptide based PCSK9 vaccine
GB201820687D0 (en) * 2018-12-19 2019-01-30 Kymab Ltd Antagonists
BR112021013807A2 (pt) 2019-01-18 2021-11-30 Astrazeneca Ab Inibidores de pcsk9 e seus métodos de uso
EP4640848A2 (en) 2019-05-17 2025-10-29 Regeneron Pharmaceuticals, Inc. Genome-based methods for reducing cardiovascular risk
US20230167188A1 (en) * 2020-07-02 2023-06-01 Biolojic Design Ltd. Anti-tumor necrosis factor receptor (tnfr2) antibodies and uses thereof

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WO2009055783A2 (en) * 2007-10-26 2009-04-30 Schering Corporation Anti-pcsk9 and methods for treating lipid and cholesterol disorders
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US20130344085A1 (en) 2013-12-26
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US9266961B2 (en) 2016-02-23
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