JP7502286B2 - 抗ｐｃｓｋ９抗体を含む安定製剤 - Google Patents

抗ｐｃｓｋ９抗体を含む安定製剤 Download PDF

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Publication number
JP7502286B2
JP7502286B2 JP2021523466A JP2021523466A JP7502286B2 JP 7502286 B2 JP7502286 B2 JP 7502286B2 JP 2021523466 A JP2021523466 A JP 2021523466A JP 2021523466 A JP2021523466 A JP 2021523466A JP 7502286 B2 JP7502286 B2 JP 7502286B2
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antibody
amino acid
acid sequence
formulation
antigen
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Japanese (ja)
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JP2022519796A5 (https=
JP2022519796A (ja
Inventor
▲劉▼洪川
▲劉▼沛想
▲張▼静
丁申皓
▲張▼梅
▲呉▼▲純▼
▲馮▼▲輝▼
武海
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Shanghai Junshi Biosciences Co Ltd
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Shanghai Junshi Biosciences Co Ltd
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    • 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
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against enzymes
    • 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
    • C07K2317/20—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
    • C07K2317/50—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
    • C07K2317/70—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
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • 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

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)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
JP2021523466A 2018-10-31 2019-10-30 抗ｐｃｓｋ９抗体を含む安定製剤 Active JP7502286B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN201811283440.7 2018-10-31
CN201811283440.7A CN111110841A (zh) 2018-10-31 2018-10-31 含有抗pcsk9抗体的稳定制剂
PCT/CN2019/114233 WO2020088492A1 (zh) 2018-10-31 2019-10-30 含有抗pcsk9抗体的稳定制剂

Publications (3)

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JP2022519796A JP2022519796A (ja) 2022-03-25
JP2022519796A5 JP2022519796A5 (https=) 2022-10-24
JP7502286B2 true JP7502286B2 (ja) 2024-06-18

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ID=70464340

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JP2021523466A Active JP7502286B2 (ja) 2018-10-31 2019-10-30 抗ｐｃｓｋ９抗体を含む安定製剤

Country Status (6)

Country Link
US (1) US20210393777A1 (https=)
EP (1) EP3878467A4 (https=)
JP (1) JP7502286B2 (https=)
KR (1) KR20210096105A (https=)
CN (3) CN111110841A (https=)
WO (1) WO2020088492A1 (https=)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116261448A (zh) * 2020-08-19 2023-06-13 百奥泰生物制药股份有限公司 用于治疗il-6相关疾病的包含高浓度人源化抗体的液体制剂
CN114344460B (zh) * 2020-10-13 2025-09-19 信立泰(成都)生物技术有限公司 含有抗pcsk9抗体的稳定制剂及其制备方法和用途
JP2025522576A (ja) * 2022-06-30 2025-07-15 エーディー ファーマシューティカルズ カンパニー，リミティド 抗ｐｃｓｋ９抗体製剤及びその応用

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014525915A (ja) 2011-07-28 2014-10-02 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 抗ｐｃｓｋ９抗体を含む安定化製剤
WO2017088782A1 (zh) 2015-11-27 2017-06-01 上海君实生物医药科技股份有限公司 抗pcsk9抗体及其应用

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6629949B1 (en) 2000-05-08 2003-10-07 Sterling Medivations, Inc. Micro infusion drug delivery device
US6659982B2 (en) 2000-05-08 2003-12-09 Sterling Medivations, Inc. Micro infusion drug delivery device
JO3672B1 (ar) * 2008-12-15 2020-08-27 Regeneron Pharma أجسام مضادة بشرية عالية التفاعل الكيماوي بالنسبة لإنزيم سبتيليسين كنفرتيز بروبروتين / كيكسين نوع 9 (pcsk9).
EP2501408B1 (en) * 2009-11-20 2020-05-27 Biocon Limited Formulations of antibody
EP3409289B1 (en) * 2010-02-26 2020-09-30 Novo Nordisk A/S Stable antibody containing compositions
EA039663B1 (ru) * 2012-05-03 2022-02-24 Амген Инк. Применение антитела против pcsk9 для снижения сывороточного холестерина лпнп и лечения связанных с холестерином расстройств
MX2018003298A (es) * 2015-09-22 2018-06-20 Pfizer Metodo para preparar una formulacion de proteinas terapeuticas y formulacion de anticuerpos producida por tal metodo.

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014525915A (ja) 2011-07-28 2014-10-02 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 抗ｐｃｓｋ９抗体を含む安定化製剤
WO2017088782A1 (zh) 2015-11-27 2017-06-01 上海君实生物医药科技股份有限公司 抗pcsk9抗体及其应用

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
Jorgensen, L. et al.，Recent trends in stabilising peptides and proteins in pharmaceutical formulation - considerations in the choice of excipients，Expert Opinion on Drug Delivery，2009年，Vol.6, No.11，p.1219-1230，doi:10.1517/17425240903199143
Shire, S. J.，4 - Formulation of proteins and monoclonal antibodies (mAbs)，Monoclonal Antibodies，Woodhead Publishing，2015年，p.93-120，https://doi.org/10.1016/B978-0-08-100296-4.00004-X.，ISBN 9780081002964

Also Published As

Publication number Publication date
CN112955180A (zh) 2021-06-11
WO2020088492A1 (zh) 2020-05-07
CN121130072A (zh) 2025-12-16
EP3878467A4 (en) 2022-08-10
EP3878467A1 (en) 2021-09-15
CN111110841A (zh) 2020-05-08
JP2022519796A (ja) 2022-03-25
US20210393777A1 (en) 2021-12-23
KR20210096105A (ko) 2021-08-04

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