JP2023501377A - 高濃度抗ｃ５抗体配合物 - Google Patents

高濃度抗ｃ５抗体配合物 Download PDF

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Publication number
JP2023501377A
JP2023501377A JP2022526120A JP2022526120A JP2023501377A JP 2023501377 A JP2023501377 A JP 2023501377A JP 2022526120 A JP2022526120 A JP 2022526120A JP 2022526120 A JP2022526120 A JP 2022526120A JP 2023501377 A JP2023501377 A JP 2023501377A
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aqueous solution
stable aqueous
ultomiris
solution
dose
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Japanese (ja)
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JP2023501377A5 (https=
Inventor
リーナ フィロミナタン，
ブルース メイソン，
Original Assignee
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
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Publication of JP2023501377A publication Critical patent/JP2023501377A/ja
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Priority to JP2025250896A priority Critical patent/JP2026048838A/ja
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    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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
    • A61K2039/55—Medicinal preparations containing antigens or antibodies characterised by the host/recipient, e.g. newborn with maternal antibodies
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
JP2022526120A 2019-11-08 2020-11-04 高濃度抗ｃ５抗体配合物 Withdrawn JP2023501377A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025250896A JP2026048838A (ja) 2019-11-08 2025-12-15 高濃度抗ｃ５抗体配合物

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201962932674P 2019-11-08 2019-11-08
US62/932,674 2019-11-08
US202062992319P 2020-03-20 2020-03-20
US62/992,319 2020-03-20
PCT/US2020/058779 WO2021091937A1 (en) 2019-11-08 2020-11-04 High concentration anti-c5 antibody formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2025250896A Division JP2026048838A (ja) 2019-11-08 2025-12-15 高濃度抗ｃ５抗体配合物

Publications (2)

Publication Number Publication Date
JP2023501377A true JP2023501377A (ja) 2023-01-18
JP2023501377A5 JP2023501377A5 (https=) 2023-11-07

Family

ID=73646451

Family Applications (2)

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JP2022526120A Withdrawn JP2023501377A (ja) 2019-11-08 2020-11-04 高濃度抗ｃ５抗体配合物
JP2025250896A Pending JP2026048838A (ja) 2019-11-08 2025-12-15 高濃度抗ｃ５抗体配合物

Family Applications After (1)

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JP2025250896A Pending JP2026048838A (ja) 2019-11-08 2025-12-15 高濃度抗ｃ５抗体配合物

Country Status (4)

Country Link
US (1) US20230002482A1 (https=)
EP (1) EP4054634A1 (https=)
JP (2) JP2023501377A (https=)
WO (1) WO2021091937A1 (https=)

Families Citing this family (8)

* 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
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
EP4281472A1 (en) * 2021-01-22 2023-11-29 Alexion Pharmaceuticals, Inc. Methods of treating complement mediated thrombotic microangiopathy using an anti-c5 antibody
CN119454939A (zh) * 2024-11-28 2025-02-18 北海康成(苏州)生物制药有限公司 一种欧莫扑拜单抗原液及其制备方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017123636A1 (en) * 2016-01-11 2017-07-20 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment
WO2019023564A1 (en) * 2017-07-27 2019-01-31 Alexion Pharmaceutical, Inc. ANTI-C5 ANTIBODY FORMULATIONS WITH HIGH CONCENTRATION
WO2019084438A1 (en) * 2017-10-26 2019-05-02 Alexion Pharmaceuticals, Inc. ASSAY AND ADMINISTRATION OF ANTI-C5 ANTIBODIES FOR THE TREATMENT OF NOCTURNAL PAROXYSTIC HEMOGLOBINURIA (PNH) AND ATYPICAL HEMOLYTIC AND UREMIC SYNDROME (AHUS)

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7919094B2 (en) 2004-06-10 2011-04-05 Omeros Corporation Methods for treating conditions associated with MASP-2 dependent complement activation
US8367805B2 (en) 2004-11-12 2013-02-05 Xencor, Inc. Fc variants with altered binding to FcRn
NZ631007A (en) 2014-03-07 2015-10-30 Alexion Pharma Inc Anti-c5 antibodies having improved pharmacokinetics

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017123636A1 (en) * 2016-01-11 2017-07-20 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment
WO2019023564A1 (en) * 2017-07-27 2019-01-31 Alexion Pharmaceutical, Inc. ANTI-C5 ANTIBODY FORMULATIONS WITH HIGH CONCENTRATION
WO2019084438A1 (en) * 2017-10-26 2019-05-02 Alexion Pharmaceuticals, Inc. ASSAY AND ADMINISTRATION OF ANTI-C5 ANTIBODIES FOR THE TREATMENT OF NOCTURNAL PAROXYSTIC HEMOGLOBINURIA (PNH) AND ATYPICAL HEMOLYTIC AND UREMIC SYNDROME (AHUS)

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
"RECIPE: SODIUM PHOSPHATE", COLD SPRING HARBOR PROTOCOLS, JPN5023001931, 20 March 2015 (2015-03-20), pages 1, ISSN: 0005663456 *
HIGHLIGHTS OF PRESCRIBING INFORMATION - ULTOMIRIS(R) (RAVULIZUMAB-CWVZ) INJECTION, FOR INTRAVENOUS U, JPN5023001930, October 2019 (2019-10-01), pages 1 - 31, ISSN: 0005663457 *

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Publication number Publication date
US20230002482A1 (en) 2023-01-05
WO2021091937A1 (en) 2021-05-14
JP2026048838A (ja) 2026-03-17
EP4054634A1 (en) 2022-09-14

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