CN115315251A - 高浓度抗Aβ初原纤维抗体配制品及其使用方法 - Google Patents

高浓度抗Aβ初原纤维抗体配制品及其使用方法 Download PDF

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Publication number
CN115315251A
CN115315251A CN202180019180.6A CN202180019180A CN115315251A CN 115315251 A CN115315251 A CN 115315251A CN 202180019180 A CN202180019180 A CN 202180019180A CN 115315251 A CN115315251 A CN 115315251A
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Prior art keywords
arginine
pharmaceutical formulation
concentration
fragment
formulations
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Pending
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CN202180019180.6A
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English (en)
Chinese (zh)
Inventor
吉田宜央
樱本奈绪美
坂口贵久
鬼头宏和
小泽崇浩
A·乔希
Y·Y·许
P·索伊拉克
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Sanitary Material R&d Management Co ltd
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Sanitary Material R&d Management Co ltd
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Publication of CN115315251A publication Critical patent/CN115315251A/zh
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    • 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
    • A61K39/39591Stabilisation, fragmentation
    • 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
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/133Amines having hydroxy groups, e.g. sphingosine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia

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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)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Cosmetics (AREA)
CN202180019180.6A 2020-03-20 2021-03-19 高浓度抗Aβ初原纤维抗体配制品及其使用方法 Pending CN115315251A (zh)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202062992746P 2020-03-20 2020-03-20
US62/992,746 2020-03-20
US202063027263P 2020-05-19 2020-05-19
US63/027,263 2020-05-19
PCT/IB2021/000155 WO2021186245A1 (en) 2020-03-20 2021-03-19 HIGH CONCENTRATION ANTI-Aß PROTOFIBRIL ANTIBODY FORMULATIONS AND METHODS OF USE THEREOF

Publications (1)

Publication Number Publication Date
CN115315251A true CN115315251A (zh) 2022-11-08

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Family Applications (1)

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CN202180019180.6A Pending CN115315251A (zh) 2020-03-20 2021-03-19 高浓度抗Aβ初原纤维抗体配制品及其使用方法

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US (1) US20230183328A1 (https=)
EP (2) EP4121007B1 (https=)
JP (2) JP7689141B2 (https=)
KR (1) KR20220156534A (https=)
CN (1) CN115315251A (https=)
AU (1) AU2021238951A1 (https=)
BR (1) BR112022018766A2 (https=)
CA (1) CA3174778A1 (https=)
CL (2) CL2022002517A1 (https=)
CO (1) CO2022012916A2 (https=)
DK (1) DK4121007T3 (https=)
ES (1) ES3041762T3 (https=)
FI (1) FI4121007T3 (https=)
HR (1) HRP20251087T1 (https=)
HU (1) HUE072937T2 (https=)
IL (2) IL295383B1 (https=)
LT (1) LT4121007T (https=)
MA (1) MA59082B1 (https=)
MD (1) MD4121007T2 (https=)
MX (1) MX2022011101A (https=)
PH (1) PH12022552172A1 (https=)
PL (1) PL4121007T3 (https=)
PT (1) PT4121007T (https=)
RS (1) RS67249B1 (https=)
SI (1) SI4121007T1 (https=)
SM (1) SMT202500350T1 (https=)
WO (1) WO2021186245A1 (https=)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20230039734A (ko) 2020-07-23 2023-03-21 오타이르 프로테나 리미티드 항-Aβ 항체
AU2022307687A1 (en) 2021-07-09 2024-01-04 Eisai R&D Management Co., Ltd. Biomarkers for alzheimer's disease treatment
AU2022439338A1 (en) 2022-02-02 2024-08-15 Eisai R&D Management Co., Ltd. Methods of treatment using p-tau181 level
JP2025539394A (ja) 2022-11-28 2025-12-05 エーザイ・アール・アンド・ディー・マネジメント株式会社 タウpetレベルを使用する治療の方法
KR20260022396A (ko) 2023-06-09 2026-02-19 에자이 알앤드디 매니지먼트 가부시키가이샤 항-Aβ 프로토피브릴 항체를 사용한 치료 방법
WO2026015877A1 (en) 2024-07-12 2026-01-15 Eisai R&D Management Co., Ltd. Fluid biomarker

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020023530A2 (en) * 2018-07-24 2020-01-30 Eisai R&D Management Co., Ltd. Methods of treatment and prevention of alzheimer's disease

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PE20091174A1 (es) * 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
CN118370815A (zh) 2017-08-22 2024-07-23 渤健马萨诸塞州股份有限公司 含有抗β淀粉样蛋白抗体的药物组合物

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020023530A2 (en) * 2018-07-24 2020-01-30 Eisai R&D Management Co., Ltd. Methods of treatment and prevention of alzheimer's disease

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Publication number Publication date
PT4121007T (pt) 2025-09-25
LT4121007T (lt) 2025-09-25
BR112022018766A2 (pt) 2022-11-01
CA3174778A1 (en) 2021-09-23
EP4121007B1 (en) 2025-07-02
IL295383B1 (en) 2026-04-01
HUE072937T2 (hu) 2025-12-28
RS67249B1 (sr) 2025-10-31
TW202200201A (zh) 2022-01-01
KR20220156534A (ko) 2022-11-25
JP2023518066A (ja) 2023-04-27
PH12022552172A1 (en) 2023-12-11
FI4121007T3 (fi) 2025-09-11
EP4121007A1 (en) 2023-01-25
EP4252777A9 (en) 2024-03-06
MX2022011101A (es) 2022-10-03
PL4121007T3 (pl) 2025-11-03
JP2025111516A (ja) 2025-07-30
WO2021186245A1 (en) 2021-09-23
MA59082B1 (fr) 2025-09-30
CL2022002517A1 (es) 2023-03-24
ES3041762T3 (en) 2025-11-14
SMT202500350T1 (it) 2025-11-10
CL2024003428A1 (es) 2025-04-11
JP7689141B2 (ja) 2025-06-05
HRP20251087T1 (hr) 2025-11-07
SI4121007T1 (sl) 2025-10-30
CO2022012916A2 (es) 2022-09-20
IL295383A (en) 2022-10-01
AU2021238951A1 (en) 2022-10-20
IL326613A (en) 2026-04-01
EP4252777A3 (en) 2024-01-24
DK4121007T3 (da) 2025-09-22
US20230183328A1 (en) 2023-06-15
MD4121007T2 (ro) 2025-11-30
EP4252777A2 (en) 2023-10-04

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