TWI704157B - 在c5相關疾病之治療或預防中使用的醫藥組成物與治療或預防c5相關疾病的方法 - Google Patents

在c5相關疾病之治療或預防中使用的醫藥組成物與治療或預防c5相關疾病的方法 Download PDF

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TWI704157B
TWI704157B TW109108378A TW109108378A TWI704157B TW I704157 B TWI704157 B TW I704157B TW 109108378 A TW109108378 A TW 109108378A TW 109108378 A TW109108378 A TW 109108378A TW I704157 B TWI704157 B TW I704157B
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antibody
hvr
dose
pharmaceutical composition
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TW109108378A
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Chinese (zh)
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TW202024128A (zh
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四宮賢治
五反田圭介
西村純一
艾瑞卡 溫特
家瑜 許
Original Assignee
日商中外製藥股份有限公司
瑞士商F. 霍夫曼-拉羅公司
國立大學法人大阪大學
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • 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
    • 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
    • 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
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06—Antianaemics
    • 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
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • 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
    • 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

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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)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Transplantation (AREA)
  • Genetics & Genomics (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
TW109108378A 2018-08-01 2019-08-01 在c5相關疾病之治療或預防中使用的醫藥組成物與治療或預防c5相關疾病的方法 TWI704157B (zh)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US201862713211P 2018-08-01 2018-08-01
US62/713,211 2018-08-01
US201862764952P 2018-08-17 2018-08-17
US62/764,952 2018-08-17
US201862760204P 2018-11-13 2018-11-13
US62/760,204 2018-11-13

Publications (2)

Publication Number Publication Date
TW202024128A TW202024128A (zh) 2020-07-01
TWI704157B true TWI704157B (zh) 2020-09-11

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TW109108378A TWI704157B (zh) 2018-08-01 2019-08-01 在c5相關疾病之治療或預防中使用的醫藥組成物與治療或預防c5相關疾病的方法
TW108127358A TWI701041B (zh) 2018-08-01 2019-08-01 在c5相關疾病之治療或預防中使用的醫藥組成物與治療或預防c5相關疾病的方法

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US (1) US20210301004A1 (enExample)
EP (2) EP3829628B1 (enExample)
JP (4) JP6672516B2 (enExample)
KR (5) KR20200033348A (enExample)
CN (1) CN112512563A (enExample)
AU (2) AU2019315213B2 (enExample)
BR (1) BR112021001655A2 (enExample)
CA (1) CA3107618A1 (enExample)
CR (1) CR20210103A (enExample)
DE (1) DE112019003835T5 (enExample)
ES (1) ES2980137T3 (enExample)
HR (1) HRP20240823T1 (enExample)
HU (1) HUE067057T2 (enExample)
IL (1) IL280475B1 (enExample)
MX (2) MX2021000516A (enExample)
MY (1) MY210523A (enExample)
PH (1) PH12021550226A1 (enExample)
PL (1) PL3829628T3 (enExample)
RS (1) RS65630B1 (enExample)
SG (1) SG10202002898RA (enExample)
SM (1) SMT202400271T1 (enExample)
TW (2) TWI704157B (enExample)
WO (1) WO2020027279A1 (enExample)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2006381B1 (en) 2006-03-31 2016-02-03 Chugai Seiyaku Kabushiki Kaisha Method for controlling blood pharmacokinetics of antibodies
CA2700701C (en) 2007-09-26 2020-12-29 Chugai Seiyaku Kabushiki Kaisha Method of modifying isoelectric point of antibody via amino acid substitution in cdr
NZ717429A (en) 2008-04-11 2018-07-27 Chugai Pharmaceutical Co Ltd Antigen-binding molecule capable of binding to two or more antigen molecules repeatedly
CN108715614A (zh) 2010-11-30 2018-10-30 中外制药株式会社 与多分子的抗原重复结合的抗原结合分子
TWI617580B (zh) 2014-12-19 2018-03-11 中外製藥股份有限公司 抗ｃ５抗體及使用方法
KR102650420B1 (ko) 2014-12-19 2024-03-21 추가이 세이야쿠 가부시키가이샤 항-마이오스타틴 항체, 변이체 Fc 영역을 함유하는 폴리펩타이드, 및 사용 방법
JP7141336B2 (ja) 2015-12-25 2022-09-22 中外製薬株式会社 抗ミオスタチン抗体および使用方法
TW202300168A (zh) 2016-08-05 2023-01-01 日商中外製藥股份有限公司 Il-8相關疾病之治療用或預防用組成物

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017509312A (ja) * 2014-12-19 2017-04-06 中外製薬株式会社 抗ｃ５抗体および使用方法
WO2017123636A1 (en) * 2016-01-11 2017-07-20 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment

Family Cites Families (29)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL85035A0 (en) 1987-01-08 1988-06-30 Int Genetic Eng Polynucleotide molecule,a chimeric antibody with specificity for human b cell surface antigen,a process for the preparation and methods utilizing the same
EP0307434B2 (en) 1987-03-18 1998-07-29 Scotgen Biopharmaceuticals, Inc. Altered antibodies
DE122004000008I1 (de) 1991-06-14 2005-06-09 Genentech Inc Humanisierter Heregulin Antikörper.
EP0714409A1 (en) 1993-06-16 1996-06-05 Celltech Therapeutics Limited Antibodies
US6074642A (en) 1994-05-02 2000-06-13 Alexion Pharmaceuticals, Inc. Use of antibodies specific to human complement component C5 for the treatment of glomerulonephritis
US6194551B1 (en) 1998-04-02 2001-02-27 Genentech, Inc. Polypeptide variants
DE69937291T2 (de) 1998-04-02 2008-07-10 Genentech, Inc., South San Francisco Antikörpervarianten und fragmente davon
US6737056B1 (en) 1999-01-15 2004-05-18 Genentech, Inc. Polypeptide variants with altered effector function
KR101155191B1 (ko) 1999-01-15 2012-06-13 제넨테크, 인크. 효과기 기능이 변화된 폴리펩티드 변이체
CA2424379C (en) 2000-10-10 2013-10-01 Tanox, Inc. Inhibition of complement c5 activation for the treatment and prevention of delayed xenograft or acute vascular rejection
BRPI0211953B8 (pt) 2001-08-17 2021-05-25 Genentech Inc anticorpo monoclonal ou fragmento de ligação a antígeno que se liga a c5 e c5a sem a prevenção da formação de c5b, linhagem celular, composição farmacêutica, bem como método in vitro para inibir a atividade de c5a e método de diagnóstico in vitro
ITMI20021527A1 (it) 2002-07-11 2004-01-12 Consiglio Nazionale Ricerche Anticorpi anti componente c5 del complemento e loro uso
US7361740B2 (en) 2002-10-15 2008-04-22 Pdl Biopharma, Inc. Alteration of FcRn binding affinities or serum half-lives of antibodies by mutagenesis
DE60332957D1 (de) 2002-12-16 2010-07-22 Genentech Inc Immunoglobulinvarianten und deren verwendungen
US20050169921A1 (en) 2004-02-03 2005-08-04 Leonard Bell Method of treating hemolytic disease
US20070116710A1 (en) 2004-02-03 2007-05-24 Leonard Bell Methods of treating hemolytic anemia
PL1737891T3 (pl) 2004-04-13 2013-08-30 Hoffmann La Roche Przeciwciała przeciw selektynie p
TWI380996B (zh) 2004-09-17 2013-01-01 Hoffmann La Roche 抗ｏｘ４０ｌ抗體
CA3022097C (en) 2006-03-15 2020-10-27 Alexion Pharmaceuticals, Inc. Treatment of paroxysmal nocturnal hemoglobinuria patients by an inhibitor of complement
NZ717429A (en) 2008-04-11 2018-07-27 Chugai Pharmaceutical Co Ltd Antigen-binding molecule capable of binding to two or more antigen molecules repeatedly
PT2328616E (pt) 2008-08-05 2015-08-26 Novartis Ag Composições e métodos para anticorpos dirigidos à proteína c5 do complemento
AU2009313203B2 (en) 2008-11-10 2015-08-27 Alexion Pharmaceuticals, Inc. Methods and compositions for treating complement-associated disorders
WO2011111007A2 (en) 2010-03-11 2011-09-15 Rinat Neuroscience Corporation ANTIBODIES WITH pH DEPENDENT ANTIGEN BINDING
TWI667346B (zh) 2010-03-30 2019-08-01 中外製藥股份有限公司 促進抗原消失之具有經修飾的FcRn親和力之抗體
CA2899589C (en) * 2013-01-31 2022-02-22 Seoul National University R & Db Foundation C5 antibody and method for preventing and treating complement-related diseases
EP4269440A3 (en) * 2015-02-27 2024-02-28 Chugai Seiyaku Kabushiki Kaisha Composition for treating il-6-related diseases
MA53248A (fr) 2016-01-25 2022-02-16 Takeda Pharmaceuticals Co Anticorps anti-c5 à commutation ph améliorée
BR112020008182A2 (pt) * 2017-10-26 2020-10-27 Alexion Pharmaceuticals, Inc. dosagem e administração de anticorpos anti-c5 para tratamento de hemoglobinúria paroxística noturna (hpn) e síndrome hemolítica urêmica atípica (shua)
KR20200095485A (ko) * 2017-12-04 2020-08-10 라 파마슈티컬스 인코포레이티드 보체 활성의 조절인자

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017509312A (ja) * 2014-12-19 2017-04-06 中外製薬株式会社 抗ｃ５抗体および使用方法
WO2017123636A1 (en) * 2016-01-11 2017-07-20 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment

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US20210301004A1 (en) 2021-09-30
EP3829628A1 (en) 2021-06-09
SMT202400271T1 (it) 2024-07-09
AU2019315213A1 (en) 2021-03-25
JP2020079331A (ja) 2020-05-28
CA3107618A1 (en) 2020-02-06
WO2020027279A1 (en) 2020-02-06
CR20210103A (es) 2021-03-22
JP2020073608A (ja) 2020-05-14
SG10202002898RA (en) 2020-05-28
ES2980137T3 (es) 2024-09-30
MX2025010400A (es) 2025-10-01
MX2021000516A (es) 2021-04-12
BR112021001655A2 (pt) 2021-05-04
KR20210038697A (ko) 2021-04-07
AU2024205486A1 (en) 2024-08-22
KR20210037743A (ko) 2021-04-06
KR20200033225A (ko) 2020-03-27
KR20240115904A (ko) 2024-07-26
JP6672516B2 (ja) 2020-03-25
RS65630B1 (sr) 2024-07-31
DE112019003835T5 (de) 2021-05-27
TW202024128A (zh) 2020-07-01
PL3829628T3 (pl) 2024-08-19
HRP20240823T1 (hr) 2024-09-27
TWI701041B (zh) 2020-08-11
AU2019315213B2 (en) 2024-05-02
TW202019467A (zh) 2020-06-01
MY210523A (en) 2025-09-29
HUE067057T2 (hu) 2024-09-28
EP3829628B1 (en) 2024-05-15
EP4445913A3 (en) 2025-01-01
JP2020019769A (ja) 2020-02-06
KR20200033348A (ko) 2020-03-27
EP4445913A2 (en) 2024-10-16
JP6672533B1 (ja) 2020-03-25
IL280475A (en) 2021-03-01
PH12021550226A1 (en) 2021-10-11
CN112512563A (zh) 2021-03-16
EP3829628C0 (en) 2024-05-15
IL280475B1 (en) 2025-12-01
JP2025065367A (ja) 2025-04-17

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