CN114828826A - 含有抗体配制品的立赞利珠单抗 - Google Patents

含有抗体配制品的立赞利珠单抗 Download PDF

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Publication number
CN114828826A
CN114828826A CN202080075626.2A CN202080075626A CN114828826A CN 114828826 A CN114828826 A CN 114828826A CN 202080075626 A CN202080075626 A CN 202080075626A CN 114828826 A CN114828826 A CN 114828826A
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CN
China
Prior art keywords
pharmaceutical composition
concentration
rituximab
suitably
antibody
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
CN202080075626.2A
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English (en)
Chinese (zh)
Inventor
F·比克尔
L·博阿多
D·切利乌斯
F·格里奥德
C·伊贝尔
F·克勒纳
J·西格
R·保罗
M·安科
A·耶伦科
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.)
Novartis AG
Original Assignee
Novartis AG
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 Novartis AG filed Critical Novartis AG
Publication of CN114828826A publication Critical patent/CN114828826A/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
    • A61K47/02—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
    • A61K47/08—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
    • A61K47/26—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
    • A61K9/08—Solutions
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06—Antianaemics
    • 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
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2851—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the lectin superfamily, e.g. CD23, CD72
    • C07K16/2854—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the lectin superfamily, e.g. CD23, CD72 against selectins, e.g. CD62
    • 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
    • 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
    • C07K2317/90—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)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
CN202080075626.2A 2019-10-30 2020-10-29 含有抗体配制品的立赞利珠单抗 Pending CN114828826A (zh)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US201962927720P 2019-10-30 2019-10-30
US201962927716P 2019-10-30 2019-10-30
US62/927,716 2019-10-30
US62/927,720 2019-10-30
US201962933692P 2019-11-11 2019-11-11
US62/933,692 2019-11-11
US201962936269P 2019-11-15 2019-11-15
US62/936,269 2019-11-15
PCT/US2020/057868 WO2021087050A1 (en) 2019-10-30 2020-10-29 Crizanlizumab containing antibody formulation

Publications (1)

Publication Number Publication Date
CN114828826A true CN114828826A (zh) 2022-07-29

Family

ID=73544317

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202080075626.2A Pending CN114828826A (zh) 2019-10-30 2020-10-29 含有抗体配制品的立赞利珠单抗

Country Status (19)

Country Link
US (1) US20220378912A1 (enExample)
EP (1) EP4051236A1 (enExample)
JP (1) JP2023501155A (enExample)
KR (1) KR20220092917A (enExample)
CN (1) CN114828826A (enExample)
AU (1) AU2020373017B2 (enExample)
BR (1) BR112022008097A2 (enExample)
CA (1) CA3158921A1 (enExample)
CL (1) CL2022001085A1 (enExample)
CO (1) CO2022005207A2 (enExample)
EC (1) ECSP22033601A (enExample)
IL (1) IL292403A (enExample)
JO (1) JOP20220097A1 (enExample)
MX (1) MX2022005044A (enExample)
MY (1) MY209141A (enExample)
PE (1) PE20221276A1 (enExample)
PH (1) PH12022551041A1 (enExample)
TW (1) TWI893018B (enExample)
WO (1) WO2021087050A1 (enExample)

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HUE041957T2 (hu) 2006-12-01 2019-06-28 Novartis Ag Anti-P-szelektin antitestek és eljárások azok alkalmazására gyulladásos betegségek kezelésére
JOP20190101A1 (ar) * 2016-11-03 2019-05-05 Novartis Ag أنظمة علاج
US10646569B2 (en) * 2017-05-16 2020-05-12 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity
CA3092931A1 (en) * 2018-03-08 2019-09-12 Novartis Ag Use of an anti-p-selectin antibody

Also Published As

Publication number Publication date
IL292403A (en) 2022-06-01
TW202128221A (zh) 2021-08-01
WO2021087050A1 (en) 2021-05-06
MX2022005044A (es) 2022-05-16
ECSP22033601A (es) 2022-05-31
CA3158921A1 (en) 2021-05-06
AU2020373017B2 (en) 2024-06-06
PH12022551041A1 (en) 2023-04-24
CO2022005207A2 (es) 2022-05-10
BR112022008097A2 (pt) 2022-08-02
KR20220092917A (ko) 2022-07-04
JOP20220097A1 (ar) 2023-01-30
EP4051236A1 (en) 2022-09-07
JP2023501155A (ja) 2023-01-18
US20220378912A1 (en) 2022-12-01
CL2022001085A1 (es) 2023-02-03
AU2020373017A1 (en) 2022-05-19
MY209141A (en) 2025-06-24
TWI893018B (zh) 2025-08-11
PE20221276A1 (es) 2022-09-05

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CB03 Change of inventor or designer information

Inventor after: F. Bicker

Inventor after: A. Yelenko

Inventor after: L. M. Boado Chavez

Inventor after: D. Cherius

Inventor after: F. Griod

Inventor after: Ibert Christophe

Inventor after: F. Klerner

Inventor after: J. Siegel

Inventor after: R. Paul

Inventor after: M. Anke

Inventor before: F. Bicker

Inventor before: A. Yelenko

Inventor before: 50. Boado

Inventor before: D. Cherius

Inventor before: F. Griod

Inventor before: Ibert Christophe

Inventor before: F. Klerner

Inventor before: J. Siegel

Inventor before: R. Paul

Inventor before: M. Anke

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