WO2020173431A3 - 包含抗cd47抗体的制剂及其制备方法和用途 - Google Patents

包含抗cd47抗体的制剂及其制备方法和用途 Download PDF

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Publication number
WO2020173431A3
WO2020173431A3 PCT/CN2020/076611 CN2020076611W WO2020173431A3 WO 2020173431 A3 WO2020173431 A3 WO 2020173431A3 CN 2020076611 W CN2020076611 W CN 2020076611W WO 2020173431 A3 WO2020173431 A3 WO 2020173431A3
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Prior art keywords
antibody
preparation
preparations containing
containing anti
use therefor
Prior art date
Application number
PCT/CN2020/076611
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English (en)
French (fr)
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WO2020173431A2 (zh
Inventor
谢瑞霞
马丽强
汪音爵
周凯松
Original Assignee
信达生物制药(苏州)有限公司
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Application filed by 信达生物制药(苏州)有限公司 filed Critical 信达生物制药(苏州)有限公司
Priority to AU2020227770A priority Critical patent/AU2020227770A1/en
Priority to CA3131307A priority patent/CA3131307A1/en
Priority to US17/433,780 priority patent/US20220143180A1/en
Priority to KR1020217030704A priority patent/KR20210134926A/ko
Priority to EP20763678.8A priority patent/EP3932426A4/en
Priority to CN202080014878.4A priority patent/CN113453719A/zh
Priority to JP2021549889A priority patent/JP2022521624A/ja
Publication of WO2020173431A2 publication Critical patent/WO2020173431A2/zh
Publication of WO2020173431A3 publication Critical patent/WO2020173431A3/zh

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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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • 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

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

Abstract

本发明公开了包含抗CD47抗体的制剂，尤其是包含抗体、缓冲剂、稳定剂和表面活性剂的药物制剂。此外，本发明还公开了这些制剂的疾病治疗或预防用途。
PCT/CN2020/076611 2019-02-26 2020-02-25 包含抗cd47抗体的制剂及其制备方法和用途 WO2020173431A2 (zh)

Priority Applications (7)

Application Number Priority Date Filing Date Title
AU2020227770A AU2020227770A1 (en) 2019-02-26 2020-02-25 Preparations containing anti-CD47 antibody, and preparation method and use therefor
CA3131307A CA3131307A1 (en) 2019-02-26 2020-02-25 Formulation comprising anti-cd47 antibody, preparation method therefor and use thereof
US17/433,780 US20220143180A1 (en) 2019-02-26 2020-02-25 Formulation comprising anti-cd47 antibody, preparation method therefor and use thereof
KR1020217030704A KR20210134926A (ko) 2019-02-26 2020-02-25 항-cd47 항체를 포함하는 제제, 이의 제조 방법 및 이의 용도
EP20763678.8A EP3932426A4 (en) 2019-02-26 2020-02-25 PREPARATIONS WITH ANTI-CD47 ANTIBODY, PROCESS FOR THEIR PRODUCTION AND THEIR USE
CN202080014878.4A CN113453719A (zh) 2019-02-26 2020-02-25 包含抗cd47抗体的制剂及其制备方法和用途
JP2021549889A JP2022521624A (ja) 2019-02-26 2020-02-25 抗ｃｄ４７抗体を含む製剤、その調製方法および使用

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201910141894.9 2019-02-26
CN201910141894 2019-02-26

Publications (2)

Publication Number Publication Date
WO2020173431A2 WO2020173431A2 (zh) 2020-09-03
WO2020173431A3 true WO2020173431A3 (zh) 2020-10-22

Family

ID=72239062

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PCT/CN2020/076611 WO2020173431A2 (zh) 2019-02-26 2020-02-25 包含抗cd47抗体的制剂及其制备方法和用途

Country Status (9)

Country Link
US (1) US20220143180A1 (zh)
EP (1) EP3932426A4 (zh)
JP (1) JP2022521624A (zh)
KR (1) KR20210134926A (zh)
CN (1) CN113453719A (zh)
AU (1) AU2020227770A1 (zh)
CA (1) CA3131307A1 (zh)
TW (1) TWI764097B (zh)
WO (1) WO2020173431A2 (zh)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3168600A1 (en) * 2020-01-21 2021-07-29 Innovent Biologics (Suzhou) Co., Ltd. Recombinant fully human anti-tigit monoclonal antibody formulation, method for preparing same and use thereof
KR20230119179A (ko) * 2020-12-10 2023-08-16 우시 바이올로직스 아일랜드 리미티드 P-캐드히린에 대한 항체 및 이의 용도
AU2021464886A1 (en) * 2021-09-16 2024-04-11 Shanghai Miracogen Inc. Antibody drug conjugate formulation and use thereof
AR127270A1 (es) * 2021-10-09 2024-01-03 Hutchmed Ltd Formulación de anticuerpos anti-cd47
WO2023246790A1 (zh) * 2022-06-21 2023-12-28 广东菲鹏制药股份有限公司 一种含抗cd47抗体或其抗原结合片段的制剂及其制备方法和应用

Citations (3)

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Publication number Priority date Publication date Assignee Title
CN106084052A (zh) * 2016-06-17 2016-11-09 长春金赛药业有限责任公司 抗cd47单克隆抗体及其应用
CN106117354A (zh) * 2016-06-24 2016-11-16 安徽未名细胞治疗有限公司 一种全人源抗CD47的全分子IgG抗体及其应用
WO2018075960A1 (en) * 2016-10-21 2018-04-26 Tioma Therapeutics, Inc. Therapeutic cd47 antibodies

Family Cites Families (5)

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Publication number Priority date Publication date Assignee Title
JP2007008895A (ja) * 2005-07-04 2007-01-18 Chugai Pharmaceut Co Ltd 抗ｃｄ４７抗体とインテグリンリガンドとの併用
EP4349868A2 (en) * 2010-05-14 2024-04-10 The Board of Trustees of the Leland Stanford Junior University Humanized and chimeric monoclonal antibodies to cd47
US9216219B2 (en) * 2012-06-12 2015-12-22 Novartis Ag Anti-BAFFR antibody formulation
US9221908B2 (en) * 2012-12-12 2015-12-29 Vasculox, Inc. Therapeutic CD47 antibodies
CA2999277A1 (en) * 2015-09-21 2017-03-30 Surface Oncology, Inc. Anti-cd47 antibodies and methods of use

Patent Citations (3)

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CN106084052A (zh) * 2016-06-17 2016-11-09 长春金赛药业有限责任公司 抗cd47单克隆抗体及其应用
CN106117354A (zh) * 2016-06-24 2016-11-16 安徽未名细胞治疗有限公司 一种全人源抗CD47的全分子IgG抗体及其应用
WO2018075960A1 (en) * 2016-10-21 2018-04-26 Tioma Therapeutics, Inc. Therapeutic cd47 antibodies

Non-Patent Citations (1)

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Title
YANG, YUN ET AL.: "A novel bispecific antibody fusion protein co-targeting EGFR and CD47 with enhanced therapeutic index", BIOTECHNOLOGY LETTERS, vol. 40, no. 5, 29 March 2018 (2018-03-29), XP036481704, DOI: 20200731183022A *

Also Published As

Publication number Publication date
CA3131307A1 (en) 2020-09-03
JP2022521624A (ja) 2022-04-11
TWI764097B (zh) 2022-05-11
KR20210134926A (ko) 2021-11-11
US20220143180A1 (en) 2022-05-12
WO2020173431A2 (zh) 2020-09-03
AU2020227770A1 (en) 2021-09-23
EP3932426A4 (en) 2022-12-14
EP3932426A2 (en) 2022-01-05
TW202045136A (zh) 2020-12-16
CN113453719A (zh) 2021-09-28

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