WO2018210230A8 - 一种pd-l1抗体药物组合物及其用途 - Google Patents

一种pd-l1抗体药物组合物及其用途 Download PDF

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Publication number
WO2018210230A8
WO2018210230A8 PCT/CN2018/086866 CN2018086866W WO2018210230A8 WO 2018210230 A8 WO2018210230 A8 WO 2018210230A8 CN 2018086866 W CN2018086866 W CN 2018086866W WO 2018210230 A8 WO2018210230 A8 WO 2018210230A8
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WIPO (PCT)
Prior art keywords
pharmaceutical composition
antibody pharmaceutical
antibody
provides
present
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PCT/CN2018/086866
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English (en)
French (fr)
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WO2018210230A1 (zh
Inventor
颜贞
杨健健
颜晓丹
吴珊
刘洵
Original Assignee
江苏恒瑞医药股份有限公司
上海恒瑞医药有限公司
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Application filed by 江苏恒瑞医药股份有限公司, 上海恒瑞医药有限公司 filed Critical 江苏恒瑞医药股份有限公司
Priority to BR112019023846A priority Critical patent/BR112019023846A2/pt
Priority to US16/614,148 priority patent/US11654194B2/en
Priority to MX2019013751A priority patent/MX2019013751A/es
Priority to CA3062487A priority patent/CA3062487A1/en
Priority to MYPI2019006627A priority patent/MY195465A/en
Priority to EP18801322.1A priority patent/EP3626266A4/en
Priority to KR1020197036735A priority patent/KR102623679B1/ko
Priority to AU2018267843A priority patent/AU2018267843A1/en
Priority to RU2019139093A priority patent/RU2766590C2/ru
Priority to CN201880007923.6A priority patent/CN110198739B/zh
Priority to JP2019563895A priority patent/JP7263256B6/ja
Publication of WO2018210230A1 publication Critical patent/WO2018210230A1/zh
Publication of WO2018210230A8 publication Critical patent/WO2018210230A8/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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • 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
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • 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
    • 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
    • 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
    • C07K16/2827—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 against B7 molecules, e.g. CD80, CD86
    • 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

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

Abstract

本发明提供了一种PD-L1抗体药物组合物及其用途。具体而言，本发明提供了一种药物组合物，其包含琥珀酸盐缓冲剂中的PD-L1抗体或其抗原结合片段。除此之外，该药物组合物还可含有糖和非离子表面活性剂。
PCT/CN2018/086866 2017-05-16 2018-05-15 一种pd-l1抗体药物组合物及其用途 WO2018210230A1 (zh)

Priority Applications (11)

Application Number Priority Date Filing Date Title
BR112019023846A BR112019023846A2 (pt) 2017-05-16 2018-05-15 composição farmacêutica de anticorpo de pd-l1 e uso da mesma
US16/614,148 US11654194B2 (en) 2017-05-16 2018-05-15 PD-L1 antibody pharmaceutical composition and use thereof
MX2019013751A MX2019013751A (es) 2017-05-16 2018-05-15 Composicion farmaceutica de anticuerpos del ligando 1 de muerte programada y su uso.
CA3062487A CA3062487A1 (en) 2017-05-16 2018-05-15 Pd-l1 antibody pharmaceutical composition and use thereof
MYPI2019006627A MY195465A (en) 2017-05-16 2018-05-15 PD-L1 Antibody Pharmaceutical Composition and use Thereof
EP18801322.1A EP3626266A4 (en) 2017-05-16 2018-05-15 CTLA4 ANTIBODY PHARMACEUTICAL COMPOSITION AND USES THEREOF
KR1020197036735A KR102623679B1 (ko) 2017-05-16 2018-05-15 Pd-l1 항체 약학 조성물 및 이의 용도
AU2018267843A AU2018267843A1 (en) 2017-05-16 2018-05-15 PD-L1 antibody pharmaceutical composition and use thereof
RU2019139093A RU2766590C2 (ru) 2017-05-16 2018-05-15 Фармацевтическая композиция на основе антитела к pd-l1 и ее применение
CN201880007923.6A CN110198739B (zh) 2017-05-16 2018-05-15 一种pd-l1抗体药物组合物及其用途
JP2019563895A JP7263256B6 (ja) 2017-05-16 2018-05-15 Ｐｄ－ｌ１抗体医薬組成物およびその使用

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201710341680 2017-05-16
CN201710341680.7 2017-05-16

Publications (2)

Publication Number Publication Date
WO2018210230A1 WO2018210230A1 (zh) 2018-11-22
WO2018210230A8 true WO2018210230A8 (zh) 2019-09-26

Family

ID=64273337

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2018/086866 WO2018210230A1 (zh) 2017-05-16 2018-05-15 一种pd-l1抗体药物组合物及其用途

Country Status (13)

Country Link
US (1) US11654194B2 (zh)
EP (1) EP3626266A4 (zh)
JP (1) JP7263256B6 (zh)
KR (1) KR102623679B1 (zh)
CN (1) CN110198739B (zh)
AU (1) AU2018267843A1 (zh)
BR (1) BR112019023846A2 (zh)
CA (1) CA3062487A1 (zh)
MX (1) MX2019013751A (zh)
MY (1) MY195465A (zh)
RU (1) RU2766590C2 (zh)
TW (1) TWI734916B (zh)
WO (1) WO2018210230A1 (zh)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR112018009064A8 (pt) * 2015-11-17 2019-02-26 Jiangsu Hengrui Medicine Co anticorpo de pd-l1, fragmento de ligação ao antígeno do mesmo e aplicação médica do mesmo
WO2020108497A1 (zh) * 2018-11-29 2020-06-04 和铂医药（香港）有限公司 一种抗pd-l1抗体制剂
BR112021013415A2 (pt) * 2019-01-07 2021-12-28 Univ Jefferson Proteínas de fusão multifuncionais e usos das mesmas
CN112125975B (zh) * 2019-06-25 2024-03-01 上海翰森生物医药科技有限公司 Pd-l1和cd47双特异性融合蛋白及其医药用途
KR20220030956A (ko) 2019-07-05 2022-03-11 오노 야꾸힝 고교 가부시키가이샤 Pd-1/cd3 이중 특이성 단백질에 의한 혈액암 치료
TW202120550A (zh) 2019-08-08 2021-06-01 日商小野藥品工業股份有限公司 雙特異性蛋白質
CN112618482A (zh) * 2019-09-24 2021-04-09 江苏恒瑞医药股份有限公司 新型蛋白制剂
US20240342083A1 (en) * 2021-07-29 2024-10-17 Shanghai Junshi Biosciences Co., Ltd. Anti-pd-1 antibody pharmaceutical composition and use thereof
CN118382643A (zh) * 2022-01-05 2024-07-23 上海迈晋生物医药科技有限公司 一种包含抗FXI/FXIa抗体的药物组合物及其用途

Family Cites Families (12)

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CN100360184C (zh) 1995-07-27 2008-01-09 基因技术股份有限公司 稳定等渗的冻干蛋白质制剂
DK0999853T3 (da) * 1997-06-13 2003-04-22 Genentech Inc Stabiliseret antostofformulering
CA2466034C (en) 2001-11-08 2012-12-18 Protein Design Labs, Inc. Stable aqueous pharmaceutical formulations of daclizumab antibodies
DK1907424T3 (en) * 2005-07-01 2015-11-09 Squibb & Sons Llc HUMAN MONOCLONAL ANTIBODIES TO PROGRAMMED death ligand 1 (PD-L1)
CN108997498A (zh) * 2008-12-09 2018-12-14 霍夫曼-拉罗奇有限公司 抗-pd-l1抗体及它们用于增强t细胞功能的用途
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MX341076B (es) 2011-03-31 2016-08-04 Merck Sharp & Dohme Formulaciones estables de anticuerpos para el receptor humano pd-1 de meurte programada y tratamientos relacionados.
EA201991715A1 (ru) 2013-09-27 2020-03-31 Дженентек, Инк. Композиции, содержащие антитело к pdl1
HUE041469T2 (hu) 2014-02-04 2019-05-28 Pfizer PD-1 antagonista és VEGFR inhibitor kombinációja rák kezelésére
MX2018003306A (es) 2015-09-28 2018-05-16 Suzhou Suncadia Biopharmaceuticals Co Ltd Preparacion farmaceutica de anticuerpo anti-pd-1 estable y aplicacion del mismo en medicina.
BR112018009064A8 (pt) * 2015-11-17 2019-02-26 Jiangsu Hengrui Medicine Co anticorpo de pd-l1, fragmento de ligação ao antígeno do mesmo e aplicação médica do mesmo
CN107198773A (zh) 2017-06-08 2017-09-26 上海药明生物技术有限公司 重组抗pd‑l1全人单克隆抗体的液体制剂

Also Published As

Publication number Publication date
WO2018210230A1 (zh) 2018-11-22
CA3062487A1 (en) 2018-11-22
US20200069800A1 (en) 2020-03-05
US11654194B2 (en) 2023-05-23
CN110198739A (zh) 2019-09-03
BR112019023846A2 (pt) 2020-06-09
RU2766590C2 (ru) 2022-03-15
RU2019139093A3 (zh) 2021-08-10
AU2018267843A1 (en) 2019-12-12
RU2019139093A (ru) 2021-06-16
EP3626266A1 (en) 2020-03-25
MY195465A (en) 2023-01-25
JP2020520939A (ja) 2020-07-16
TWI734916B (zh) 2021-08-01
EP3626266A4 (en) 2021-04-07
KR20200005650A (ko) 2020-01-15
CN110198739B (zh) 2023-04-04
TW201900211A (zh) 2019-01-01
JP7263256B6 (ja) 2023-07-24
KR102623679B1 (ko) 2024-01-11
MX2019013751A (es) 2020-01-15
JP7263256B2 (ja) 2023-04-24

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