BR112020001703B1 - Solução aquosa estável compreendendo um anticorpo anti-c5, método para produção desta solução, uso da mesma para tratar uma condição associada ao complemento e kit terapêutico compreendendo a mesma - Google Patents

Solução aquosa estável compreendendo um anticorpo anti-c5, método para produção desta solução, uso da mesma para tratar uma condição associada ao complemento e kit terapêutico compreendendo a mesma Download PDF

Info

Publication number
BR112020001703B1
BR112020001703B1 BR112020001703-5A BR112020001703A BR112020001703B1 BR 112020001703 B1 BR112020001703 B1 BR 112020001703B1 BR 112020001703 A BR112020001703 A BR 112020001703A BR 112020001703 B1 BR112020001703 B1 BR 112020001703B1
Authority
BR
Brazil
Prior art keywords
antibody
aqueous solution
alxn1210
months
solution
Prior art date
Application number
BR112020001703-5A
Other languages
English (en)
Portuguese (pt)
Other versions
BR112020001703A2 (pt
Inventor
Stephan Ortiz
Jillian Gentile
Leena Philominathan
Eric Routhier
Bruce Mason
Original Assignee
Alexion Pharmaceuticals, Inc
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 Alexion Pharmaceuticals, Inc filed Critical Alexion Pharmaceuticals, Inc
Publication of BR112020001703A2 publication Critical patent/BR112020001703A2/pt
Publication of BR112020001703B1 publication Critical patent/BR112020001703B1/pt

Links

Classifications

    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], 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
    • A61K47/02—Inorganic compounds
    • 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
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • 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
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/526—CH3 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • 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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
BR112020001703-5A 2017-07-27 2018-07-27 Solução aquosa estável compreendendo um anticorpo anti-c5, método para produção desta solução, uso da mesma para tratar uma condição associada ao complemento e kit terapêutico compreendendo a mesma BR112020001703B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762537741P 2017-07-27 2017-07-27
US62/537,741 2017-07-27
PCT/US2018/044071 WO2019023564A1 (en) 2017-07-27 2018-07-27 ANTI-C5 ANTIBODY FORMULATIONS WITH HIGH CONCENTRATION

Publications (2)

Publication Number Publication Date
BR112020001703A2 BR112020001703A2 (pt) 2020-07-21
BR112020001703B1 true BR112020001703B1 (pt) 2024-01-02

Family

ID=63209670

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112020001703-5A BR112020001703B1 (pt) 2017-07-27 2018-07-27 Solução aquosa estável compreendendo um anticorpo anti-c5, método para produção desta solução, uso da mesma para tratar uma condição associada ao complemento e kit terapêutico compreendendo a mesma

Country Status (19)

Country Link
US (4) US11365241B2 (https=)
EP (2) EP3658184B1 (https=)
JP (4) JP7079844B2 (https=)
KR (2) KR102576012B1 (https=)
CN (2) CN116271012A (https=)
AU (3) AU2018306612C1 (https=)
BR (1) BR112020001703B1 (https=)
CA (1) CA3069756C (https=)
CO (1) CO2020001960A2 (https=)
DK (1) DK3658184T5 (https=)
ES (1) ES2965486T3 (https=)
FI (1) FI3658184T3 (https=)
HU (1) HUE064436T2 (https=)
LT (1) LT3658184T (https=)
MX (2) MX392444B (https=)
PL (1) PL3658184T3 (https=)
PT (1) PT3658184T (https=)
SI (1) SI3658184T1 (https=)
WO (1) WO2019023564A1 (https=)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3024618A1 (en) 2016-05-27 2017-11-30 Alexion Pharmaceuticals, Inc. Methods for treatment of refractory generalized myasthenia gravis
DK3658184T5 (da) 2017-07-27 2024-08-26 Alexion Pharma Inc Højkoncentrerede anti-c5-antistofformuleringer
CN118512588A (zh) 2017-10-26 2024-08-20 亚力兄制药公司 用于治疗阵发性夜间性血红蛋白尿(pnh)和非典型溶血性尿毒症综合征(ahus)的抗c5抗体的剂量和施用
EP3802603A1 (en) 2018-06-04 2021-04-14 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of atypical hemolytic uremic syndrome (ahus) in pediatric patients
US12312394B2 (en) 2018-06-28 2025-05-27 Alexion Pharmaceuticals, Inc. Methods of producing anti-C5 antibodies
EP3873602B1 (en) * 2018-10-30 2023-12-06 Alexion Pharmaceuticals, Inc. Subcutaneous dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh)
CN117838856A (zh) * 2019-01-25 2024-04-09 亚力兄制药公司 用于治疗非典型溶血性尿毒综合征(ahus)的抗c5抗体的剂量和施用
EP3924380A1 (en) * 2019-02-14 2021-12-22 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of generalized myasthenia gravis
WO2021034639A1 (en) * 2019-08-16 2021-02-25 Regeneron Pharmaceuticals, Inc. High concentration anti-c5 formulations
EP4021497B1 (en) * 2019-08-30 2026-02-25 Kashiv Biosciences, LLC Novel formulation of highly concentrated pharmacologically active antibody
US20220356234A1 (en) * 2019-10-02 2022-11-10 Alexion Pharmaceuticals, Inc. Complement inhibitors for treating drug-induced complement-mediated response
WO2021091937A1 (en) * 2019-11-08 2021-05-14 Alexion Pharmaceuticals, Inc. High concentration anti-c5 antibody formulations
CN115605184A (zh) * 2020-05-15 2023-01-13 豪夫迈·罗氏有限公司（Ch） 防止胃肠外蛋白质溶液中的可见颗粒形成
EP4213940A1 (en) * 2020-09-21 2023-07-26 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treating c5-mediated glomerular nephritis (gn), including lupus nephritis (ln) and/or iga nephropathy (igan)
EP4281472A1 (en) * 2021-01-22 2023-11-29 Alexion Pharmaceuticals, Inc. Methods of treating complement mediated thrombotic microangiopathy using an anti-c5 antibody
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
TW202423479A (zh) * 2022-09-28 2024-06-16 美商阿雷希昂製藥公司 用於預防或最小化患有慢性腎病的患者中的心臟手術相關急性腎損傷（csa-aki）和/或隨後的主要不良腎事件（make）的抗c5抗體之劑量及投與
CN116712390B (zh) * 2023-08-04 2023-11-14 上海览屹医药科技有限公司 一种高浓度高稳定性的抗体制剂及其制备方法
CN118604345A (zh) * 2024-05-31 2024-09-06 上海览屹医药科技有限公司 酶联免疫方法测定单克隆抗体浓度
CN121186347B (zh) * 2025-11-24 2026-02-24 国家心血管病中心 一种利用动脉血对目标物质进行免疫检测的方法和试剂盒

Family Cites Families (125)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3710795A (en) 1970-09-29 1973-01-16 Alza Corp Drug-delivery device with stretched, rate-controlling membrane
US4485045A (en) 1981-07-06 1984-11-27 Research Corporation Synthetic phosphatidyl cholines useful in forming liposomes
US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
US4544545A (en) 1983-06-20 1985-10-01 Trustees University Of Massachusetts Liposomes containing modified cholesterol for organ targeting
US4980286A (en) 1985-07-05 1990-12-25 Whitehead Institute For Biomedical Research In vivo introduction and expression of foreign genetic material in epithelial cells
IL79289A (en) 1985-07-05 1992-01-15 Whitehead Biomedical Inst Introduction and expression of foreign genetic material into keratinocytes using a recombinant retrovirus
US4863457A (en) 1986-11-24 1989-09-05 Lee David A Drug delivery device
JP3101690B2 (ja) 1987-03-18 2000-10-23 エス・ビィ・２・インコーポレイテッド 変性抗体の、または変性抗体に関する改良
ATE117375T1 (de) 1987-09-11 1995-02-15 Whitehead Biomedical Inst Transduktionsveränderte fibroblasten und ihre anwendung.
JP2914692B2 (ja) 1987-12-11 1999-07-05 ホワイトヘツド・インスチチユート・フオー・バイオメデイカル・リサーチ 内皮細胞の遺伝子修飾
WO1989007136A2 (en) 1988-02-05 1989-08-10 Whitehead Institute For Biomedical Research Modified hepatocytes and uses therefor
US5013556A (en) 1989-10-20 1991-05-07 Liposome Technology, Inc. Liposomes with enhanced circulation time
US5164188A (en) 1989-11-22 1992-11-17 Visionex, Inc. Biodegradable ocular implants
ES2096750T3 (es) 1990-10-31 1997-03-16 Somatix Therapy Corp Vectores retroviricos utiles para la terapia genica.
KR0185215B1 (ko) 1990-11-30 1999-05-01 요시다 쇼오지 서방성 안구삽입용 약제
US5714350A (en) 1992-03-09 1998-02-03 Protein Design Labs, Inc. Increasing antibody affinity by altering glycosylation in the immunoglobulin variable region
CA2137667A1 (en) 1992-07-23 1994-02-03 Todd A. Berg Shaped abrasive particles and method of making same
US6005079A (en) 1992-08-21 1999-12-21 Vrije Universiteit Brussels Immunoglobulins devoid of light chains
DK1621554T4 (da) 1992-08-21 2012-12-17 Univ Bruxelles Immunoglobuliner blottet for lette kæder
US5885573A (en) 1993-06-01 1999-03-23 Arch Development Corporation Methods and materials for modulation of the immunosuppressive activity and toxicity of monoclonal antibodies
IT1265573B1 (it) 1993-09-17 1996-11-22 Zanussi Grandi Impianti Spa Forno di cottura di alimenti con porta perfezionata
US5308341A (en) 1993-09-28 1994-05-03 Becton, Dickinson And Company Method of testing the dose accuracy of a medication delivery device
US5443505A (en) 1993-11-15 1995-08-22 Oculex Pharmaceuticals, Inc. Biocompatible ocular implants
ATE416755T1 (de) 1994-03-07 2008-12-15 Nektar Therapeutics Verfahren und zusammensetzung für die pulmonale darreichung von insulin
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
US6019968A (en) 1995-04-14 2000-02-01 Inhale Therapeutic Systems, Inc. Dispersible antibody compositions and methods for their preparation and use
ES2176484T3 (es) 1995-08-18 2002-12-01 Morphosys Ag Bancos de proteinas/(poli)peptidos.
US5773019A (en) 1995-09-27 1998-06-30 The University Of Kentucky Research Foundation Implantable controlled release device to deliver drugs directly to an internal portion of the body
JP4046354B2 (ja) 1996-03-18 2008-02-13 ボード オブ リージェンツ，ザ ユニバーシティ オブ テキサス システム 増大した半減期を有する免疫グロブリン様ドメイン
US6001329A (en) 1996-05-06 1999-12-14 Uab Research Foundation Radiolabeled fusion toxins for cancer therapy
US6146361A (en) 1996-09-26 2000-11-14 Becton Dickinson And Company Medication delivery pen having a 31 gauge needle
WO1998023289A1 (en) 1996-11-27 1998-06-04 The General Hospital Corporation MODULATION OF IgG BINDING TO FcRn
GB9626960D0 (en) 1996-12-27 1997-02-12 Glaxo Group Ltd Valve for aerosol container
US6277375B1 (en) 1997-03-03 2001-08-21 Board Of Regents, The University Of Texas System Immunoglobulin-like domains with increased half-lives
WO1998047531A2 (en) 1997-04-21 1998-10-29 Arch Development Corporation Fc receptor non-binding anti-cd3 monoclonal antibodies deliver a partial tcr signal and induce clonal anergy
US5954047A (en) 1997-10-17 1999-09-21 Systemic Pulmonary Development, Ltd. Methods and apparatus for delivering aerosolized medication
US6194551B1 (en) 1998-04-02 2001-02-27 Genentech, Inc. Polypeptide variants
US6302855B1 (en) 1998-05-20 2001-10-16 Novo Nordisk A/S Medical apparatus for use by a patient for medical self treatment of diabetes
US6737056B1 (en) 1999-01-15 2004-05-18 Genentech, Inc. Polypeptide variants with altered effector function
PL209392B1 (pl) 1999-01-15 2011-08-31 Genentech Inc Przeciwciało, komórka gospodarza, sposób wytwarzania przeciwciała oraz zastosowanie przeciwciała
JP2002541213A (ja) 1999-04-13 2002-12-03 インヘール セラピューティック システムズ， インコーポレイテッド 不妊症の処置のための乾燥粉末処方物の肺投与
WO2000061178A1 (en) 1999-04-13 2000-10-19 Inhale Therapeutics Systems, Inc. Pulmonary administration of dry powder formulations for treating infertility
US6192891B1 (en) 1999-04-26 2001-02-27 Becton Dickinson And Company Integrated system including medication delivery pen, blood monitoring device, and lancer
GB9910975D0 (en) 1999-05-13 1999-07-14 Univ Strathclyde Rapid dehydration of proteins
US6277099B1 (en) 1999-08-06 2001-08-21 Becton, Dickinson And Company Medication delivery pen
PE20011227A1 (es) 2000-04-17 2002-01-07 Chiesi Farma Spa Formulaciones farmaceuticas para inhaladores de polvo seco en la forma de aglomerados duros
DE60135352D1 (de) 2000-08-30 2008-09-25 Univ Johns Hopkins Vorrichtung zur intraokularen wirkstoffverabreichung
US7083784B2 (en) 2000-12-12 2006-08-01 Medimmune, Inc. Molecules with extended half-lives, compositions and uses thereof
WO2003022330A2 (en) 2001-09-12 2003-03-20 Becton, Dickinson And Company Microneedle-based pen device for drug delivery and method for using same
AU2003217912A1 (en) 2002-03-01 2003-09-16 Xencor Antibody optimization
US20060141456A1 (en) 2002-06-12 2006-06-29 Cynthia Edwards Methods and compositions for milieu-dependent binding of a targeted agent to a target
US20050271660A1 (en) 2002-09-06 2005-12-08 Alexion Pharmaceuticals, Inc. Nebulization of monoclonal antibodies for treating pulmonary diseases
US9415102B2 (en) * 2002-09-06 2016-08-16 Alexion Pharmaceuticals, Inc. High concentration formulations of anti-C5 antibodies
US20040102469A1 (en) 2002-09-13 2004-05-27 Boehringer Ingelheim Pharma Gmbh & Co. Kg Method for reducing the mortality rate
GB0222023D0 (en) 2002-09-21 2002-10-30 Aventis Pharma Ltd Inhaler
EP1553975B8 (en) 2002-09-27 2023-04-12 Xencor, Inc. Optimized fc variants and methods for their generation
FR2849436B1 (fr) 2002-12-27 2007-01-05 Patrick Frayssinet Particules et ceramiques de phosphates de calcium pour transfection in vivo et in vitro
US20060167435A1 (en) 2003-02-18 2006-07-27 Adamis Anthony P Transscleral drug delivery device and related methods
MXPA05010555A (es) 2003-04-04 2006-03-09 Genentech Inc Formulaciones de proteina y anticuerpo de alta concentracion.
EP1648511A1 (en) 2003-07-29 2006-04-26 Morphotek, Inc. Antibodies and methods for generating genetically altered antibodies with enhanced effector function
GB0324368D0 (en) 2003-10-17 2003-11-19 Univ Cambridge Tech Polypeptides including modified constant regions
EP1697520A2 (en) 2003-12-22 2006-09-06 Xencor, Inc. Fc polypeptides with novel fc ligand binding sites
EP1737890A2 (en) 2004-03-24 2007-01-03 Xencor, Inc. Immunoglobulin variants outside the fc region
US8685435B2 (en) 2004-04-30 2014-04-01 Allergan, Inc. Extended release biodegradable ocular implants
US7919094B2 (en) 2004-06-10 2011-04-05 Omeros Corporation Methods for treating conditions associated with MASP-2 dependent complement activation
GB0416328D0 (en) 2004-07-21 2004-08-25 Univ Cardiff Use of dry powder compositions for pulmonary delivery
US20060074225A1 (en) 2004-09-14 2006-04-06 Xencor, Inc. Monomeric immunoglobulin Fc domains
AU2005304624B2 (en) 2004-11-12 2010-10-07 Xencor, Inc. Fc variants with altered binding to FcRn
US8367805B2 (en) 2004-11-12 2013-02-05 Xencor, Inc. Fc variants with altered binding to FcRn
US8802820B2 (en) 2004-11-12 2014-08-12 Xencor, Inc. Fc variants with altered binding to FcRn
US20060234303A1 (en) 2005-03-03 2006-10-19 Xencor, Inc. Methods for the design of libraries of protein variants
WO2006105338A2 (en) 2005-03-31 2006-10-05 Xencor, Inc. Fc VARIANTS WITH OPTIMIZED PROPERTIES
WO2007041635A2 (en) 2005-10-03 2007-04-12 Xencor, Inc. Fc variants with optimized fc receptor binding properties
BRPI0620316A2 (pt) 2005-12-21 2011-11-08 Wyeth Corp formulações de proteìnas com viscosidades reduzida e seus usos
CA2638811A1 (en) 2006-02-03 2007-08-16 Medimmune, Llc Protein formulations
JP5722524B2 (ja) 2006-03-02 2015-05-20 アレクシオン ファーマシューティカルズ， インコーポレイテッド 補体活性を抑制することによる同種移植片の生存の延長
US20090220508A1 (en) 2006-03-15 2009-09-03 Alexion Pharmaceuticals, Inc. Treatment Of Paroxysmal Nocturnal Hemoglobinuria Patients By An Inhibitor Of Complement
CN104761637B (zh) 2006-03-31 2021-10-15 中外制药株式会社 调控抗体血液动力学的方法
US8037880B2 (en) 2006-04-07 2011-10-18 The University Of Western Ontario Dry powder inhaler
US20100034194A1 (en) 2006-10-11 2010-02-11 Siemens Communications Inc. Eliminating unreachable subscribers in voice-over-ip networks
AU2007313300A1 (en) 2006-10-16 2008-04-24 Medimmune, Llc. Molecules with reduced half-lives, compositions and uses thereof
WO2008092117A2 (en) 2007-01-25 2008-07-31 Xencor, Inc. Immunoglobulins with modifications in the fcr binding region
JP2010533181A (ja) 2007-07-13 2010-10-21 アボツト・バイオテクノロジー・リミテツド ＴＮＦα阻害剤の肺投与のための方法及び組成物
ES2595638T3 (es) 2007-09-26 2017-01-02 Chugai Seiyaku Kabushiki Kaisha Método para modificar el punto isoeléctrico de un anticuerpo mediante la sustitución de aminoácidos en una CDR
HRP20150279T1 (hr) 2007-12-26 2015-05-08 Xencor, Inc. Fc inaäśice s promijenjenim vezanjem na fcrn
KR102057826B1 (ko) 2008-04-11 2019-12-20 추가이 세이야쿠 가부시키가이샤 복수 분자의 항원에 반복 결합하는 항원 결합 분자
JP5913980B2 (ja) 2008-10-14 2016-05-11 ジェネンテック， インコーポレイテッド 免疫グロブリン変異体及びその用途
CA2742802C (en) 2008-11-10 2019-11-26 Alexion Pharmaceuticals, Inc. Methods and compositions for treating complement-associated disorders
AU2015227544B2 (en) 2008-11-10 2017-05-25 Alexion Pharmaceuticals, Inc. Methods and compositions for treating complement-associated disorders
US20120282654A1 (en) 2009-04-29 2012-11-08 Schering Corporation Antibody purification
CA2766565A1 (en) 2009-06-23 2010-12-29 Alexion Pharmaceuticals, Inc. Bispecific antibodies that bind to complement proteins
EP3409289B1 (en) 2010-02-26 2020-09-30 Novo Nordisk A/S Stable antibody containing compositions
JP5932670B2 (ja) 2010-03-11 2016-06-08 ライナット ニューロサイエンス コーポレイション ｐＨ依存性の抗原結合を有する抗体
TWI667257B (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
MX340696B (es) 2010-04-30 2016-07-21 Alexion Pharma Inc Anticuerpos anti-c5a y metodos para usar los anticuerpos.
BR112012027917A2 (pt) 2010-04-30 2017-11-28 Alexion Pharma Inc anticorpos que apresentam reduzida imunogenicidade em um indivíduo humano
EP2647706B1 (en) 2010-11-30 2023-05-17 Chugai Seiyaku Kabushiki Kaisha Antigen-binding molecule capable of binding to plurality of antigen molecules repeatedly
AU2012233313C1 (en) 2011-03-30 2017-08-03 Chugai Seiyaku Kabushiki Kaisha Method for altering plasma retention and immunogenicity of antigen-binding molecule
TW201817744A (zh) 2011-09-30 2018-05-16 日商中外製藥股份有限公司 具有促進抗原清除之ＦｃＲｎ結合域的治療性抗原結合分子
JP6322411B2 (ja) 2011-09-30 2018-05-09 中外製薬株式会社 複数の生理活性を有する抗原の消失を促進する抗原結合分子
US10011660B2 (en) 2012-04-30 2018-07-03 Medimmune, Llc Molecules with reduced effector function and extended half-lives, compositions, and uses thereof
US9216219B2 (en) * 2012-06-12 2015-12-22 Novartis Ag Anti-BAFFR antibody formulation
PT3889181T (pt) * 2012-09-07 2024-05-29 Regeneron Pharma Um anticorpo antagonista de il-4r para utilização no tratamento da dermatite atópica por administração
SG10201804960RA (en) * 2013-12-12 2018-07-30 Alnylam Pharmaceuticals Inc Complement component irna compositions and methods of use thereof
NZ631007A (en) 2014-03-07 2015-10-30 Alexion Pharma Inc Anti-c5 antibodies having improved pharmacokinetics
US20160168237A1 (en) * 2014-12-12 2016-06-16 Alexion Pharmaceuticals, Inc. Method for treating a complement mediated disorder caused by an infectious agent in a patient
BR112017011235A2 (pt) * 2014-12-19 2018-02-06 Chugai Pharmaceutical Co Ltd anticorpos anti-c5 e métodos de uso
EP3236772A4 (en) 2014-12-22 2018-10-17 Alexion Pharmaceuticals, Inc. Methods of purifying recombinant proteins
US20190135903A1 (en) * 2015-03-31 2019-05-09 Alexion Pharmaceuticals, Inc. Identifying and treating subpopulations of paroxysmal nocturnal hemoglobinuria (pnh) patients
US20180311299A1 (en) 2015-05-01 2018-11-01 Alexion Pharmaceuticals, Inc. Efficacy of an anti-c5 antibody in the prevention of antibody mediated rejection in sensitized recipients of a kidney transplant
EP3313437A1 (en) 2015-06-26 2018-05-02 Alexion Pharmaceuticals, Inc. A method for treating a patient in compliance with vaccination with eculizumab or an eculizumab variant
US20170073399A1 (en) 2015-09-11 2017-03-16 Alexion Pharmaceuticals, Inc. Recombinant glycosylated eculizumab and eculizumab variants
TW201726111A (zh) 2015-09-30 2017-08-01 持田製藥股份有限公司 含高濃度抗體之液體製劑
JP7221691B2 (ja) 2015-10-30 2023-02-14 アレクシオン ファーマシューティカルズ， インコーポレイテッド Ｔ細胞媒介性同種移植片血管障害の増悪を抑制する方法
EP3402816A1 (en) 2016-01-11 2018-11-21 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment
CN116769024A (zh) 2016-06-14 2023-09-19 瑞泽恩制药公司 抗c5抗体及其用途
WO2018071624A1 (en) 2016-10-12 2018-04-19 Alexion Pharmaceuticals, Inc. Efficacy of an anti-c5 antibody in the prevention of antibody mediated rejection in sensitized recipients of a kidney transplant
DK3658184T5 (da) 2017-07-27 2024-08-26 Alexion Pharma Inc Højkoncentrerede anti-c5-antistofformuleringer
CN118512588A (zh) 2017-10-26 2024-08-20 亚力兄制药公司 用于治疗阵发性夜间性血红蛋白尿(pnh)和非典型溶血性尿毒症综合征(ahus)的抗c5抗体的剂量和施用
EP3802593B1 (en) 2018-05-31 2024-09-11 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh) in pediatric patients
EP3802603A1 (en) 2018-06-04 2021-04-14 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of atypical hemolytic uremic syndrome (ahus) in pediatric patients
US12312394B2 (en) 2018-06-28 2025-05-27 Alexion Pharmaceuticals, Inc. Methods of producing anti-C5 antibodies
EP3873602B1 (en) 2018-10-30 2023-12-06 Alexion Pharmaceuticals, Inc. Subcutaneous dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh)
CN117838856A (zh) 2019-01-25 2024-04-09 亚力兄制药公司 用于治疗非典型溶血性尿毒综合征(ahus)的抗c5抗体的剂量和施用
WO2021091937A1 (en) 2019-11-08 2021-05-14 Alexion Pharmaceuticals, Inc. High concentration anti-c5 antibody formulations

Also Published As

Publication number Publication date
US20250154233A1 (en) 2025-05-15
WO2019023564A1 (en) 2019-01-31
AU2018306612B2 (en) 2022-09-01
JP2026063214A (ja) 2026-04-10
US20200369751A1 (en) 2020-11-26
JP2022105625A (ja) 2022-07-14
US20230106734A1 (en) 2023-04-06
JP2020528894A (ja) 2020-10-01
MX2022005990A (es) 2022-06-17
CN111315411A (zh) 2020-06-19
CN116271012A (zh) 2023-06-23
PT3658184T (pt) 2023-11-29
US12012448B2 (en) 2024-06-18
KR102576012B1 (ko) 2023-09-07
MX392444B (es) 2025-03-24
AU2018306612C1 (en) 2023-11-09
KR20230066126A (ko) 2023-05-12
EP4218813A2 (en) 2023-08-02
FI3658184T3 (fi) 2023-11-30
AU2022279414A1 (en) 2023-03-02
DK3658184T3 (da) 2023-11-27
CO2020001960A2 (es) 2020-04-13
BR112020001703A2 (pt) 2020-07-21
WO2019023564A8 (en) 2019-12-26
CN111315411B (zh) 2023-02-28
RU2020108198A (ru) 2021-08-27
ES2965486T3 (es) 2024-04-15
AU2018306612A1 (en) 2020-01-16
CA3069756A1 (en) 2019-01-31
JP7277649B2 (ja) 2023-05-19
HUE064436T2 (hu) 2024-03-28
EP4218813A3 (en) 2023-08-16
LT3658184T (lt) 2023-11-27
SI3658184T1 (sl) 2024-01-31
KR20200034739A (ko) 2020-03-31
US11365241B2 (en) 2022-06-21
PL3658184T3 (pl) 2024-02-26
RU2020108198A3 (https=) 2022-02-04
DK3658184T5 (da) 2024-08-26
US20230257456A1 (en) 2023-08-17
MX2020001052A (es) 2022-05-18
EP3658184B1 (en) 2023-09-06
JP2023090876A (ja) 2023-06-29
EP3658184A1 (en) 2020-06-03
JP7079844B2 (ja) 2022-06-02
AU2025263917A1 (en) 2025-12-04
CA3069756C (en) 2025-04-22

Similar Documents

Publication Publication Date Title
JP7277649B2 (ja) 高濃度抗ｃ５抗体製剤
EP3873602B1 (en) Subcutaneous dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh)
US20200297815A1 (en) Treating ige-mediated allergic diseases
AU2022369457A1 (en) Aqueous formulations of an anti-cd22 antibody and uses thereof
BR122023005826B1 (pt) Solução aquosa estável compreendendo um anticorpo anti-c5, uso da mesma para tratar uma condição associada ao complemento e kit terapêutico compreendendo a mesma
RU2847524C2 (ru) Высококонцентрированные составы антител к c5
RU2787595C2 (ru) Высококонцентрированные составы антител к c5
HK40025392A (en) High concentration anti-c5 antibody formulations
HK40025392B (en) High concentration anti-c5 antibody formulations
US20250064929A1 (en) Pharmaceutical compositions comprising anti-human tslp receptor antibodies and methods of using the same
HK40097452A (en) Subcutaneous dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh)
HK40055105A (en) Subcutaneous dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh)
HK40055105B (en) Subcutaneous dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh)

Legal Events

Date Code Title Description
B350 Update of information on the portal [chapter 15.35 patent gazette]
B154 Notification of filing of divisional application [chapter 15.50 patent gazette]

Free format text: O PEDIDO FOI DIVIDIDO NO BR122023005826-7 PROTOCOLO 870230026275 EM 29/03/2023 11:44.

B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 27/07/2018, OBSERVADAS AS CONDICOES LEGAIS