HRP20201862T1 - Anti-sklerostin protutijelo, antigen vezujući fragment i njegova medicinska uporaba - Google Patents

Anti-sklerostin protutijelo, antigen vezujući fragment i njegova medicinska uporaba Download PDF

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Publication number
HRP20201862T1
HRP20201862T1 HRP20201862TT HRP20201862T HRP20201862T1 HR P20201862 T1 HRP20201862 T1 HR P20201862T1 HR P20201862T T HRP20201862T T HR P20201862TT HR P20201862 T HRP20201862 T HR P20201862T HR P20201862 T1 HRP20201862 T1 HR P20201862T1
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Croatia
Prior art keywords
antibody
specifically binds
host cell
bone
human sclerostin
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HRP20201862TT
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English (en)
Inventor
Jiajian Liu
Yayuan FU
Haoying ZHANG
Yifang Wang
Zhen Zhang
Ling Zhang
Dongbing CUI
Lianshan Zhang
Weikang Tao
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Jiangsu Hengrui Medicine Co., Ltd.
Shanghai Hengrui Pharmaceutical Co., Ltd.
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Application filed by Jiangsu Hengrui Medicine Co., Ltd., Shanghai Hengrui Pharmaceutical Co., Ltd. filed Critical Jiangsu Hengrui Medicine Co., Ltd.
Publication of HRP20201862T1 publication Critical patent/HRP20201862T1/hr

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • A61K48/005Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the 'active' part of the composition delivered, i.e. the nucleic acid delivered
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • 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
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, 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)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biotechnology (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Wood Science & Technology (AREA)
  • Biomedical Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Mycology (AREA)
  • Physics & Mathematics (AREA)
  • Plant Pathology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (9)

1. Antijelo koje se specifično veže na humani sklerostin, sadrži teški lanac SEK ID BR: 26 i laki lanac SEK ID BR: 29.
2. DNA molekula, koji kodira antitijelo koje se specifično veže na humani sklerostin sukladno patentnom zahtjevu 1.
3. Ekspresijski vektor koji sadrži DNA molekul sukladno patentnom zahtjevu 2.
4. Stanica domaćin, koja se transformirana s ekspresijskim vektorom sukladno patentnom zahtjevu 3.
5. Stanica domaćin sukladno patentnom zahtjevu 4, pri čemu je stanica domaćin stanica sisavca.
6. Stanica domaćin sukladno patentnom zahtjevu 5, pri čemu je CHO stanica.
7. Farmaceutski pripravak, koja sadrži antitijelo sukladno patentnom zahtjevu 1, i jedan ili više farmaceutski prihvatljivog ekscipijensa, otapalo ili nosač.
8. Antitijelo koje se specifično veže na humani sklerostin sukladno patentnom zahtjevu 1 ili farmaceutski pripravak sukladno patentnom zahtjevu 7, za uporabu kao lijek, barem jednim povećanjem koštane mase, mineralne gustoće kostiju, sadržaja minerala sadržaja kostiju ili čvrstoće kostiju.
9. Antitijelo koje se specifično veže na humani sklerostin sukladno patentnom zahtjevu 1 ili farmaceutski pripravak sukladno patentnom zahtjevu 7, za uporabu za liječenje sklerostinom uzrokovane bolesti ili poremećaja kostiju odabrano od osteoporoze, osteopenijskog osteoartritisa, reumatoidnog artritisa, paradontalne bolesti i multiplog mijeloma.
HRP20201862TT 2015-03-13 2020-11-23 Anti-sklerostin protutijelo, antigen vezujući fragment i njegova medicinska uporaba HRP20201862T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN201510112924 2015-03-13
EP16764142.2A EP3269735B1 (en) 2015-03-13 2016-02-16 Anti-sclerostin antibody, antigen binding fragment and medical use thereof
PCT/CN2016/073857 WO2016145961A1 (zh) 2015-03-13 2016-02-16 抗硬骨素抗体、其抗原结合片段及其医药用途

Publications (1)

Publication Number Publication Date
HRP20201862T1 true HRP20201862T1 (hr) 2021-01-22

Family

ID=56919707

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20201862TT HRP20201862T1 (hr) 2015-03-13 2020-11-23 Anti-sklerostin protutijelo, antigen vezujući fragment i njegova medicinska uporaba

Country Status (20)

Country Link
US (1) US10449250B2 (hr)
EP (2) EP3782641A1 (hr)
JP (1) JP6755513B2 (hr)
KR (1) KR102584953B1 (hr)
CN (2) CN111196849B (hr)
AU (1) AU2016232897B2 (hr)
BR (1) BR112017019075A2 (hr)
CA (1) CA2978976C (hr)
DK (1) DK3269735T3 (hr)
ES (1) ES2835923T3 (hr)
HR (1) HRP20201862T1 (hr)
HU (1) HUE052528T2 (hr)
LT (1) LT3269735T (hr)
MX (1) MX2017011480A (hr)
PT (1) PT3269735T (hr)
RS (1) RS61158B1 (hr)
RU (1) RU2716101C2 (hr)
SI (1) SI3269735T1 (hr)
TW (2) TWI730954B (hr)
WO (1) WO2016145961A1 (hr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW201909913A (zh) * 2017-07-27 2019-03-16 大陸商江蘇恆瑞醫藥股份有限公司 一種sost抗體醫藥組成物及其用途
CN108101984B (zh) * 2017-12-18 2019-10-15 中国人民解放军总医院 骨硬化蛋白单链抗体的制备方法和用途
US20210198672A1 (en) * 2018-02-12 2021-07-01 Aptacure Therapeutics Limited Aptamer for sclerostin and use thereof
CN113913463B (zh) * 2021-09-19 2023-08-18 郭保生 抑制sost基因表达的重组质粒及其骨靶向重组腺相关病毒与应用
TW202330032A (zh) * 2021-11-30 2023-08-01 大陸商江蘇恆瑞醫藥股份有限公司 一種抗sost抗體醫藥組成物及其用途

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BRPI0411552A (pt) * 2003-06-16 2006-08-01 Celltech R & D Inc anticorpos especìficos a esclerostina e métodos para aumentar a mineralização óssea
US8003108B2 (en) 2005-05-03 2011-08-23 Amgen Inc. Sclerostin epitopes
US7592429B2 (en) 2005-05-03 2009-09-22 Ucb Sa Sclerostin-binding antibody
EP2094731A2 (en) 2006-11-10 2009-09-02 UCB Pharma S.A. Anti human sclerostin antibodies
MY165625A (en) * 2006-12-26 2018-04-18 Ct Inmunologia Molecular Pharmaceutical composition comprising an anti- cd6 monoclonal antibody useful for the diagnosis and treatment of rheumatoid arthritis
SI2131860T1 (sl) * 2007-03-20 2014-02-28 Eli Lilly And Company Protitelesa proti sklerostinu
AR068767A1 (es) * 2007-10-12 2009-12-02 Novartis Ag Anticuerpos contra esclerostina, composiciones y metodos de uso de estos anticuerpos para tratar un trastorno patologico mediado por esclerostina
JP2011506483A (ja) * 2007-12-14 2011-03-03 アムジエン・インコーポレーテツド 抗スクレロスチン抗体を用いた骨折の治療方法
WO2010130830A2 (en) 2009-05-15 2010-11-18 Ablynx N.V. Amino acid sequences directed against sclerostin and polypeptides comprising the same for the treatment of bone diseases and disorders
SG11201401791WA (en) 2011-10-24 2014-08-28 Abbvie Inc Immunobinders directed against sclerostin
SG10201509629QA (en) * 2011-12-28 2015-12-30 Amgen Inc Method Of Treating Alveolar Bone Loss Through The Use Of Anti-Sclerostin Antibodies
CN104619342A (zh) 2012-07-05 2015-05-13 Ucb医药有限公司 骨疾病的治疗
UY35148A (es) 2012-11-21 2014-05-30 Amgen Inc Immunoglobulinas heterodiméricas

Also Published As

Publication number Publication date
CA2978976A1 (en) 2016-09-22
CA2978976C (en) 2024-05-14
TW202134271A (zh) 2021-09-16
DK3269735T3 (da) 2020-12-14
CN106661104A (zh) 2017-05-10
EP3269735A1 (en) 2018-01-17
AU2016232897A1 (en) 2017-10-05
TWI790617B (zh) 2023-01-21
EP3782641A1 (en) 2021-02-24
EP3269735A4 (en) 2018-09-19
ES2835923T3 (es) 2021-06-23
CN111196849B (zh) 2021-12-21
BR112017019075A2 (pt) 2018-04-17
RU2017132924A3 (hr) 2019-06-03
AU2016232897B2 (en) 2021-05-13
LT3269735T (lt) 2020-12-28
RU2017132924A (ru) 2019-04-15
CN111196849A (zh) 2020-05-26
US10449250B2 (en) 2019-10-22
KR20170126971A (ko) 2017-11-20
KR102584953B1 (ko) 2023-10-04
CN106661104B (zh) 2019-04-02
TW201632550A (zh) 2016-09-16
MX2017011480A (es) 2018-04-24
RU2716101C2 (ru) 2020-03-05
EP3269735B1 (en) 2020-11-04
JP2018509147A (ja) 2018-04-05
RS61158B1 (sr) 2021-01-29
HUE052528T2 (hu) 2021-05-28
SI3269735T1 (sl) 2020-12-31
WO2016145961A1 (zh) 2016-09-22
PT3269735T (pt) 2020-12-04
TWI730954B (zh) 2021-06-21
US20180099046A1 (en) 2018-04-12
JP6755513B2 (ja) 2020-09-16

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