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CL2024000232A1 - Composición farmacéutica de anticuerpo anti-pd-1 y uso de la misma - Google Patents

Composición farmacéutica de anticuerpo anti-pd-1 y uso de la misma

Info

Publication number
CL2024000232A1
CL2024000232A1 CL2024000232A CL2024000232A CL2024000232A1 CL 2024000232 A1 CL2024000232 A1 CL 2024000232A1 CL 2024000232 A CL2024000232 A CL 2024000232A CL 2024000232 A CL2024000232 A CL 2024000232A CL 2024000232 A1 CL2024000232 A1 CL 2024000232A1
Authority
CL
Chile
Prior art keywords
pharmaceutical composition
seq
antibody
antigen
amino acid
Prior art date
Application number
CL2024000232A
Other languages
English (en)
Inventor
Feng Hui
Liu Hongchuan
Liu Peixiang
Du Xiaojie
Meng Qin
Liu Hui
Original Assignee
Shanghai Junshi 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 filed Critical Shanghai Junshi Biosciences Co Ltd
Publication of CL2024000232A1 publication Critical patent/CL2024000232A1/es

Links

Classifications

    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • 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
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2818Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

La presente invención proporciona una composición farmacéutica de anticuerpo anti-PD-1 estable y el uso de la misma. La composición farmacéutica comprende un tampón y un anticuerpo anti-PD-1 o un fragmento de unión a antígeno del mismo; en donde el anticuerpo anti-PD-1 o el fragmento de unión a antígeno del mismo tiene una concentración de aproximadamente 100-250 mg/ml y comprende una LCDR1, una LCDR2 y una LCDR3 que tienen las secuencias de aminoácidos establecidas en la SEQ ID NO: 1, SEQ ID NO: 2 y SEQ ID NO: 3, respectivamente, y una HCDR1, una HCDR2 y una HCDR3 que tienen secuencias de aminoácidos establecidas en la SEQ ID NO: 4, SEQ ID NO: 5 y SEQ ID NO: 6, respectivamente; y en donde la composición farmacéutica tiene un pH de aproximadamente 5.0-6.5. La presente invención también proporciona una inyección que comprende la composición farmacéutica y el uso de la composición farmacéutica y la inyección en la preparación de un medicamento para tratar una enfermedad o trastorno eliminando, inhibiendo o reduciendo la actividad de PD-1.
CL2024000232A 2021-07-29 2024-01-26 Composición farmacéutica de anticuerpo anti-pd-1 y uso de la misma CL2024000232A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202110863978 2021-07-29

Publications (1)

Publication Number Publication Date
CL2024000232A1 true CL2024000232A1 (es) 2024-07-26

Family

ID=85086307

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2024000232A CL2024000232A1 (es) 2021-07-29 2024-01-26 Composición farmacéutica de anticuerpo anti-pd-1 y uso de la misma

Country Status (11)

Country Link
US (1) US20240342083A1 (es)
EP (1) EP4376809A4 (es)
JP (1) JP2024528724A (es)
CN (1) CN116019907A (es)
AR (1) AR126614A1 (es)
AU (1) AU2022320670A1 (es)
CA (1) CA3227991A1 (es)
CL (1) CL2024000232A1 (es)
MX (1) MX2024001326A (es)
UY (1) UY39878A (es)
WO (1) WO2023006055A1 (es)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113244386A (zh) * 2020-02-13 2021-08-13 上海君实生物医药科技股份有限公司 抗pd-1抗体在治疗肿瘤中的用途
WO2025013783A1 (ja) * 2023-07-07 2025-01-16 ナガセヴィータ株式会社 タンパク質の変性抑制用組成物
WO2025113598A1 (zh) * 2023-12-01 2025-06-05 齐鲁制药有限公司 稳定的混合抗体的药物组合物
WO2025140495A1 (zh) * 2023-12-28 2025-07-03 齐鲁制药有限公司 稳定的抗pd-1抗体的药物组合物

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104250302B (zh) * 2013-06-26 2017-11-14 上海君实生物医药科技股份有限公司 抗pd‑1抗体及其应用
MX2019010999A (es) * 2017-03-29 2020-02-05 Celgene Corp Formulaciones que comprenden proteinas de union a pd-1 y metodos para preparar las mismas.
MY195465A (en) * 2017-05-16 2023-01-25 Jiangsu Hengrui Medicine Co PD-L1 Antibody Pharmaceutical Composition and use Thereof
CN111246886B (zh) * 2017-11-02 2022-03-15 正大天晴药业集团股份有限公司 一种抗pd-l1人源化单克隆抗体的药物组合物
CN110882385B (zh) * 2018-09-07 2021-07-09 上海君实生物医药科技股份有限公司 抗pd-1抗体在治疗肿瘤中的用途
JP7491220B2 (ja) * 2018-11-27 2024-05-28 小野薬品工業株式会社 免疫チェックポイント阻害薬およびfolfirinox療法との併用によるがん治療
CN112741804A (zh) * 2019-10-31 2021-05-04 上海君实生物医药科技股份有限公司 含有抗pd-l1抗体的稳定制剂
WO2022152245A1 (zh) * 2021-01-14 2022-07-21 上海君实生物医药科技股份有限公司 抗tigit抗体药物组合物及其用途

Also Published As

Publication number Publication date
AU2022320670A1 (en) 2024-03-14
MX2024001326A (es) 2024-02-15
CN116019907A (zh) 2023-04-28
AR126614A1 (es) 2023-10-25
CA3227991A1 (en) 2023-02-02
JP2024528724A (ja) 2024-07-30
UY39878A (es) 2023-02-28
WO2023006055A1 (en) 2023-02-02
EP4376809A4 (en) 2025-06-04
EP4376809A1 (en) 2024-06-05
US20240342083A1 (en) 2024-10-17

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