BR112018013256A2 - anticorpo para pcsk9, fragmento de ligação a antí-geno do mesmo e aplicação médica do mesmo - Google Patents

anticorpo para pcsk9, fragmento de ligação a antí-geno do mesmo e aplicação médica do mesmo

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Publication number
BR112018013256A2
BR112018013256A2 BR112018013256-0A BR112018013256A BR112018013256A2 BR 112018013256 A2 BR112018013256 A2 BR 112018013256A2 BR 112018013256 A BR112018013256 A BR 112018013256A BR 112018013256 A2 BR112018013256 A2 BR 112018013256A2
Authority
BR
Brazil
Prior art keywords
antibody
pcsk9
same
antigen
binding fragment
Prior art date
Application number
BR112018013256-0A
Other languages
English (en)
Chinese (zh)
Inventor
Qu Xiangdong
Ye Xin
Xu Shaoyu
Yuan Bei
Cui Dongbing
Hu Qiyue
Zhang Lei
Xu Zhibin
Tao Weikang
Zhang Lianshan
Sun Piaoyang
Original Assignee
Jiangsu Hengrui Medicine Co., Ltd.
Shanghai Hengrui Pharmaceutical Co., Ltd.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Jiangsu Hengrui Medicine Co., Ltd., Shanghai Hengrui Pharmaceutical Co., Ltd. filed Critical Jiangsu Hengrui Medicine Co., Ltd.
Publication of BR112018013256A2 publication Critical patent/BR112018013256A2/pt

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/11DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/62DNA sequences coding for fusion proteins
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/63Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14Hydrolases (3)
    • C12N9/48Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51Complete heavy chain or Fd fragment, i.e. VH + CH1
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515Complete light chain, i.e. VL + CL
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/567Framework region [FR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Biotechnology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Physics & Mathematics (AREA)
  • Plant Pathology (AREA)
  • Endocrinology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Abstract

a presente invenção refere-se a um anticorpo para pcsk9, um fragmento de ligação a antígeno do mesmo e uma aplicação médica do mesmo. é provido na invenção um anticorpo quimérico e um anticorpo humanizado, ambos compreendendo uma cdr do anticorpo para pcsk9, e uma composição farmacêutica compreendendo o anticorpo para pcsk9 e um fragmento de ligação a antígeno do mesmo e uma aplicação do anticorpo para pcsk9 como um agente de diminuição de lipídeo. a invenção refere-se especificamente a uma aplicação de um anticorpo para pcsk9 humanizado para preparação de um fármaco para tratar uma doença ou sintoma induzido por pcsk9.
BR112018013256-0A 2015-12-31 2016-12-20 anticorpo para pcsk9, fragmento de ligação a antí-geno do mesmo e aplicação médica do mesmo BR112018013256A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN201511024618.2 2015-12-31
CN201511024618 2015-12-31
PCT/CN2016/111053 WO2017114230A1 (zh) 2015-12-31 2016-12-20 Pcsk9抗体、其抗原结合片段及其医药用途

Publications (1)

Publication Number Publication Date
BR112018013256A2 true BR112018013256A2 (pt) 2018-12-11

Family

ID=59224496

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018013256-0A BR112018013256A2 (pt) 2015-12-31 2016-12-20 anticorpo para pcsk9, fragmento de ligação a antí-geno do mesmo e aplicação médica do mesmo

Country Status (13)

Country Link
US (1) US10793643B2 (pt)
EP (1) EP3398968A4 (pt)
JP (1) JP7032662B2 (pt)
KR (1) KR20180093068A (pt)
CN (1) CN107406511B (pt)
AU (1) AU2016382932B2 (pt)
BR (1) BR112018013256A2 (pt)
CA (1) CA3009904A1 (pt)
HK (1) HK1244828A1 (pt)
MX (1) MX2018007925A (pt)
RU (1) RU2739208C2 (pt)
TW (1) TWI735499B (pt)
WO (1) WO2017114230A1 (pt)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110431153B (zh) * 2017-06-30 2023-09-19 苏州盛迪亚生物医药有限公司 一种pcsk-9抗体药物组合物及其用途
CN110981962B (zh) * 2019-12-19 2022-07-12 中国药科大学 Pcsk9抗体、其抗原结合片段及其应用
CN115279409A (zh) 2020-03-19 2022-11-01 苏州盛迪亚生物医药有限公司 一种胆固醇相关疾病的治疗方法
CN114369164A (zh) * 2020-10-15 2022-04-19 苏州君盟生物医药科技有限公司 抗pcsk9单克隆抗体的生产工艺

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EP0640094A1 (en) 1992-04-24 1995-03-01 The Board Of Regents, The University Of Texas System Recombinant production of immunoglobulin-like domains in prokaryotic cells
US6277375B1 (en) 1997-03-03 2001-08-21 Board Of Regents, The University Of Texas System Immunoglobulin-like domains with increased half-lives
US7658921B2 (en) 2000-12-12 2010-02-09 Medimmune, Llc Molecules with extended half-lives, compositions and uses thereof
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Also Published As

Publication number Publication date
CN107406511A (zh) 2017-11-28
EP3398968A4 (en) 2019-08-07
CA3009904A1 (en) 2017-07-06
CN107406511B (zh) 2021-01-19
TW201725216A (zh) 2017-07-16
JP7032662B2 (ja) 2022-03-09
WO2017114230A1 (zh) 2017-07-06
RU2739208C2 (ru) 2020-12-21
KR20180093068A (ko) 2018-08-20
HK1244828A1 (zh) 2018-08-17
JP2019509254A (ja) 2019-04-04
EP3398968A1 (en) 2018-11-07
US20190016825A1 (en) 2019-01-17
RU2018125003A (ru) 2020-02-03
MX2018007925A (es) 2018-08-29
AU2016382932A1 (en) 2018-07-19
AU2016382932B2 (en) 2022-12-08
TWI735499B (zh) 2021-08-11
US10793643B2 (en) 2020-10-06
RU2018125003A3 (pt) 2020-05-13

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