CN111110841A - 含有抗pcsk9抗体的稳定制剂 - Google Patents

含有抗pcsk9抗体的稳定制剂 Download PDF

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Publication number
CN111110841A
CN111110841A CN201811283440.7A CN201811283440A CN111110841A CN 111110841 A CN111110841 A CN 111110841A CN 201811283440 A CN201811283440 A CN 201811283440A CN 111110841 A CN111110841 A CN 111110841A
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CN
China
Prior art keywords
antibody
amino acid
acid sequence
formulation
ser
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
CN201811283440.7A
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English (en)
Chinese (zh)
Inventor
刘洪川
刘沛想
丁申皓
吴纯
冯辉
武海
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.)
Shanghai Junshi Biosciences Co Ltd
Suzhou Junmeng Biosciences Co Ltd
Original Assignee
Shanghai Junshi Biosciences Co Ltd
Suzhou Junmeng Biosciences Co Ltd
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 Shanghai Junshi Biosciences Co Ltd, Suzhou Junmeng Biosciences Co Ltd filed Critical Shanghai Junshi Biosciences Co Ltd
Priority to CN201811283440.7A priority Critical patent/CN111110841A/zh
Priority to KR1020217016186A priority patent/KR20210096105A/ko
Priority to US17/290,078 priority patent/US20210393777A1/en
Priority to EP19878080.1A priority patent/EP3878467A4/en
Priority to CN202511285329.1A priority patent/CN121130072A/zh
Priority to JP2021523466A priority patent/JP7502286B2/ja
Priority to PCT/CN2019/114233 priority patent/WO2020088492A1/zh
Priority to CN201980071607.XA priority patent/CN112955180A/zh
Publication of CN111110841A publication Critical patent/CN111110841A/zh
Pending legal-status Critical Current

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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

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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)
  • 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)
CN201811283440.7A 2018-10-31 2018-10-31 含有抗pcsk9抗体的稳定制剂 Pending CN111110841A (zh)

Priority Applications (8)

Application Number Priority Date Filing Date Title
CN201811283440.7A CN111110841A (zh) 2018-10-31 2018-10-31 含有抗pcsk9抗体的稳定制剂
KR1020217016186A KR20210096105A (ko) 2018-10-31 2019-10-30 항pcsk9 항체를 함유한 안정화 제제
US17/290,078 US20210393777A1 (en) 2018-10-31 2019-10-30 Stable preparation comprising anti-pcsk9 antibody
EP19878080.1A EP3878467A4 (en) 2018-10-31 2019-10-30 STABLE FORMULATIONS WITH ANTI-PCSK9 ANTIBODIES
CN202511285329.1A CN121130072A (zh) 2018-10-31 2019-10-30 含有抗pcsk9抗体的稳定制剂
JP2021523466A JP7502286B2 (ja) 2018-10-31 2019-10-30 抗ｐｃｓｋ９抗体を含む安定製剤
PCT/CN2019/114233 WO2020088492A1 (zh) 2018-10-31 2019-10-30 含有抗pcsk9抗体的稳定制剂
CN201980071607.XA CN112955180A (zh) 2018-10-31 2019-10-30 含有抗pcsk9抗体的稳定制剂

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201811283440.7A CN111110841A (zh) 2018-10-31 2018-10-31 含有抗pcsk9抗体的稳定制剂

Publications (1)

Publication Number Publication Date
CN111110841A true CN111110841A (zh) 2020-05-08

Family

ID=70464340

Family Applications (3)

Application Number Title Priority Date Filing Date
CN201811283440.7A Pending CN111110841A (zh) 2018-10-31 2018-10-31 含有抗pcsk9抗体的稳定制剂
CN201980071607.XA Pending CN112955180A (zh) 2018-10-31 2019-10-30 含有抗pcsk9抗体的稳定制剂
CN202511285329.1A Pending CN121130072A (zh) 2018-10-31 2019-10-30 含有抗pcsk9抗体的稳定制剂

Family Applications After (2)

Application Number Title Priority Date Filing Date
CN201980071607.XA Pending CN112955180A (zh) 2018-10-31 2019-10-30 含有抗pcsk9抗体的稳定制剂
CN202511285329.1A Pending CN121130072A (zh) 2018-10-31 2019-10-30 含有抗pcsk9抗体的稳定制剂

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=)

Cited By (1)

* 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

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Family Cites Families (9)

* 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
AR087305A1 (es) * 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
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.
CN106810609A (zh) * 2015-11-27 2017-06-09 苏州君盟生物医药科技有限公司 抗pcsk9抗体及其应用

Cited By (1)

* 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

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
JP7502286B2 (ja) 2024-06-18
JP2022519796A (ja) 2022-03-25
US20210393777A1 (en) 2021-12-23
KR20210096105A (ko) 2021-08-04

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Application publication date: 20200508

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