CN115137815A - 通过使用抗c5抗体可伐利单抗来治疗或预防c5相关疾病的剂量和施用方案 - Google Patents

通过使用抗c5抗体可伐利单抗来治疗或预防c5相关疾病的剂量和施用方案 Download PDF

Info

Publication number
CN115137815A
CN115137815A CN202210474600.6A CN202210474600A CN115137815A CN 115137815 A CN115137815 A CN 115137815A CN 202210474600 A CN202210474600 A CN 202210474600A CN 115137815 A CN115137815 A CN 115137815A
Authority
CN
China
Prior art keywords
ser
antibody
val
leu
thr
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
CN202210474600.6A
Other languages
English (en)
Chinese (zh)
Inventor
A·A·B·索斯特利
S·B·M·布托伊斯
A·苏布雷
F·G·J·杰米尼翁
G·约旦
C·布歇
J-E·查洛因
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
F Hoffmann La Roche AG
Original Assignee
F Hoffmann La Roche AG
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 F Hoffmann La Roche AG filed Critical F Hoffmann La Roche AG
Publication of CN115137815A publication Critical patent/CN115137815A/zh
Pending legal-status Critical Current

Links

Images

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], 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
    • A61K39/0005Vertebrate antigens
    • A61K39/0008Antigens related to auto-immune diseases; Preparations to induce self-tolerance
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • A61P21/04Drugs for disorders of the muscular or neuromuscular system for myasthenia gravis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/14Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Rheumatology (AREA)
  • Microbiology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Neurology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
CN202210474600.6A 2019-07-31 2020-07-30 通过使用抗c5抗体可伐利单抗来治疗或预防c5相关疾病的剂量和施用方案 Pending CN115137815A (zh)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
EP19189436.9 2019-07-31
EP19189436 2019-07-31
EP20174781.3 2020-05-14
EP20174781 2020-05-14
EP20179590.3 2020-06-11
EP20179590 2020-06-11
CN202080054192.8A CN114466660A (zh) 2019-07-31 2020-07-30 通过使用抗c5抗体可伐利单抗来治疗或预防c5相关疾病的剂量和施用方案
PCT/EP2020/071551 WO2021019033A1 (en) 2019-07-31 2020-07-30 Dosage and administration regimen for the treatment or prevention of c5-related diseases by the use of the anti-c5 antibody crovalimab

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CN202080054192.8A Division CN114466660A (zh) 2019-07-31 2020-07-30 通过使用抗c5抗体可伐利单抗来治疗或预防c5相关疾病的剂量和施用方案

Publications (1)

Publication Number Publication Date
CN115137815A true CN115137815A (zh) 2022-10-04

Family

ID=71846414

Family Applications (2)

Application Number Title Priority Date Filing Date
CN202210474600.6A Pending CN115137815A (zh) 2019-07-31 2020-07-30 通过使用抗c5抗体可伐利单抗来治疗或预防c5相关疾病的剂量和施用方案
CN202080054192.8A Pending CN114466660A (zh) 2019-07-31 2020-07-30 通过使用抗c5抗体可伐利单抗来治疗或预防c5相关疾病的剂量和施用方案

Family Applications After (1)

Application Number Title Priority Date Filing Date
CN202080054192.8A Pending CN114466660A (zh) 2019-07-31 2020-07-30 通过使用抗c5抗体可伐利单抗来治疗或预防c5相关疾病的剂量和施用方案

Country Status (12)

Country Link
US (1) US20220275071A1 (https=)
EP (1) EP4003408A1 (https=)
JP (2) JP7437260B2 (https=)
KR (2) KR20240001329A (https=)
CN (2) CN115137815A (https=)
AU (1) AU2020319677A1 (https=)
CA (1) CA3144921A1 (https=)
CR (1) CR20220040A (https=)
IL (1) IL288636A (https=)
MX (1) MX2022001153A (https=)
TW (1) TWI886139B (https=)
WO (1) WO2021019033A1 (https=)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW202404632A (zh) * 2022-04-04 2024-02-01 瑞士商赫孚孟拉羅股份公司 用於藉由使用抗c5抗體克羅伐單抗治療或預防格林-巴利症候群之劑量及投予方案

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016098356A1 (en) * 2014-12-19 2016-06-23 Chugai Seiyaku Kabushiki Kaisha Anti-c5 antibodies and methods of use
WO2018109588A2 (en) * 2016-12-16 2018-06-21 Samsung Bioepis Co., Ltd Stable aqueous anti-c5 antibody composition
WO2018143266A1 (en) * 2017-01-31 2018-08-09 Chugai Seiyaku Kabushiki Kaisha A pharmaceutical composition for use in the treatment or prevention of a c5-related disease and a method for treating or preventing a c5-related disease

Family Cites Families (25)

* 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
WO1988007089A1 (en) 1987-03-18 1988-09-22 Medical Research Council Altered antibodies
EP1400536A1 (en) 1991-06-14 2004-03-24 Genentech Inc. Method for making humanized antibodies
AU691811B2 (en) 1993-06-16 1998-05-28 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
ES2292236T3 (es) 1998-04-02 2008-03-01 Genentech, Inc. Variantes de anticuerpos y sus fragmentos.
US6737056B1 (en) 1999-01-15 2004-05-18 Genentech, Inc. Polypeptide variants with altered effector function
HU230769B1 (hu) 1999-01-15 2018-03-28 Genentech Inc. Módosított effektor-funkciójú polipeptid-változatok
AU2001296594A1 (en) 2000-10-10 2002-04-22 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
EP3263596A1 (en) 2002-12-16 2018-01-03 Genentech, Inc. Immunoglobulin variants and uses thereof
US20070116710A1 (en) 2004-02-03 2007-05-24 Leonard Bell Methods of treating hemolytic anemia
US20050169921A1 (en) 2004-02-03 2005-08-04 Leonard Bell Method of treating hemolytic disease
KR100891620B1 (ko) 2004-04-13 2009-04-02 에프. 호프만-라 로슈 아게 항-p-셀렉틴 항체
TWI309240B (en) 2004-09-17 2009-05-01 Hoffmann La Roche Anti-ox40l antibodies
PL3167888T3 (pl) 2006-03-15 2024-08-26 Alexion Pharmaceuticals, Inc. Leczenie pacjentów z napadową nocną hemoglobinurią za pomocą inhibitora dopełniacza
PY09026846A (es) 2008-08-05 2015-09-01 Novartis Ag Composiciones y métodos para anticuerpos que se dirigen a la proteína de complemento c5
LT2894165T (lt) 2008-11-10 2023-03-10 Alexion Pharmaceuticals, Inc. Būdai ir kompozicijos, skirti su komplementu susijusių sutrikimų gydymui
IL259256B2 (en) 2015-12-18 2023-02-01 Chugai Pharmaceutical Co Ltd Anti-c5 antibodies and methods of use
EP3402816A1 (en) 2016-01-11 2018-11-21 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment
EP3408291A1 (en) 2016-01-25 2018-12-05 Shire Human Genetic Therapies, Inc. Anti-c5 antibodies with enhanced ph switch
CA3080187A1 (en) * 2017-10-26 2019-05-02 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh) and atypical hemolytic uremic syndrome (ahus)

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016098356A1 (en) * 2014-12-19 2016-06-23 Chugai Seiyaku Kabushiki Kaisha Anti-c5 antibodies and methods of use
WO2018109588A2 (en) * 2016-12-16 2018-06-21 Samsung Bioepis Co., Ltd Stable aqueous anti-c5 antibody composition
WO2018143266A1 (en) * 2017-01-31 2018-08-09 Chugai Seiyaku Kabushiki Kaisha A pharmaceutical composition for use in the treatment or prevention of a c5-related disease and a method for treating or preventing a c5-related disease

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
WORLD HEALTH ORGANIZATION: "International nonproprietary names for pharmaceutical substances (‎INN)‎ proposed INN list 119", 《WHO DRUG INFORMATION》, vol. 32, no. 2, 31 December 2018 (2018-12-31), pages 283 - 398 *

Also Published As

Publication number Publication date
EP4003408A1 (en) 2022-06-01
TW202120124A (zh) 2021-06-01
WO2021019033A1 (en) 2021-02-04
CN114466660A (zh) 2022-05-10
JP2022104920A (ja) 2022-07-12
AU2020319677A1 (en) 2022-01-06
CR20220040A (es) 2022-03-02
IL288636A (en) 2022-02-01
US20220275071A1 (en) 2022-09-01
KR102618269B1 (ko) 2023-12-27
JP7749495B2 (ja) 2025-10-06
JP2021038197A (ja) 2021-03-11
KR20240001329A (ko) 2024-01-03
KR20210016332A (ko) 2021-02-15
TWI886139B (zh) 2025-06-11
AU2020319677A8 (en) 2022-01-27
JP7437260B2 (ja) 2024-02-22
CA3144921A1 (en) 2021-02-04
MX2022001153A (es) 2022-02-22

Similar Documents

Publication Publication Date Title
TWI436776B (zh) Fgf21突變體及其用途
JP2024105420A (ja) 免疫性血小板減少症を治療する組成物及び方法
KR102442984B1 (ko) 글루카곤 수용체 길항 항체를 이용한 제 1 형 당뇨병의 치료 방법
KR20210005683A (ko) Cd123 및 cd3에 결합하는 이중특이적 항체의 투약
JP7749495B2 (ja) 抗c5抗体クロバリマブの使用によるc5関連疾患の治療または予防のための薬用量および投与レジメン
HK40074952A (en) Dosage and administration regimen for the treatment or prevention of c5-related diseases by the use of the anti-c5 antibody crovalimab
RU2832188C2 (ru) Дозировка и схема введения для лечения или предупреждения связанных с с5 заболеваний посредством применения антитела против с5 кровалимаба
RU2823427C2 (ru) Дозировка и схема введения для лечения или предупреждения связанных с с5 заболеваний посредством применения антитела против с5 кровалимаба
JP7748311B2 (ja) 抗c5抗体クロバリマブの使用によるc5関連疾患の治療または予防のための薬用量および投与レジメン
HK40065402A (en) Dosage and administration regimen for the treatment or prevention of c5-related diseases by the use of the anti-c5 antibody crovalimab
HK40070215A (en) Dosage and administration regimen for the treatment or prevention of c5-related diseases by the use of the anti-c5 antibody crovalimab
CN109071614B (zh) 肺炎球菌溶血素ply截短胜肽及其用途
RU2832946C2 (ru) Фармацевтическая композиция, предназначенная для применения для лечения или предупреждения связанного с c5 заболевания, и способ лечения или предупреждения связанного с c5 заболевания

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
REG Reference to a national code

Ref country code: HK

Ref legal event code: DE

Ref document number: 40074952

Country of ref document: HK