BR112019023846A2 - composição farmacêutica de anticorpo de pd-l1 e uso da mesma - Google Patents

composição farmacêutica de anticorpo de pd-l1 e uso da mesma Download PDF

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Publication number
BR112019023846A2
BR112019023846A2 BR112019023846A BR112019023846A BR112019023846A2 BR 112019023846 A2 BR112019023846 A2 BR 112019023846A2 BR 112019023846 A BR112019023846 A BR 112019023846A BR 112019023846 A BR112019023846 A BR 112019023846A BR 112019023846 A2 BR112019023846 A2 BR 112019023846A2
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BR
Brazil
Prior art keywords
pharmaceutical composition
antibody
provides
present
antigen
Prior art date
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BR112019023846A
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English (en)
Inventor
Yang Jianjian
Wu Shan
Yan Xiaodan
Liu Xun
Yan Zhen
Original Assignee
Jiangsu Hengrui Medicine Co
Shanghai hengrui pharmaceutical co ltd
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Application filed by Jiangsu Hengrui Medicine Co, Shanghai hengrui pharmaceutical co ltd filed Critical Jiangsu Hengrui Medicine Co
Publication of BR112019023846A2 publication Critical patent/BR112019023846A2/pt

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    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • 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
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • 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
    • 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
    • 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
    • C07K16/2827Immunoglobulins [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
    • 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
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (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

a presente invenção provê uma composição farmacêutica de anticorpo de pd-l1 e uso da mesma. em particular, a presente invenção provê uma composição farmacêutica compreendendo o anticorpo de pd-l1 ou um fragmento de ligação ao antígeno do mesmo em um tampão de succinato. além disso, a composição farmacêutica também pode conter um açúcar e um tensoativo não iônico.
BR112019023846A 2017-05-16 2018-05-15 composição farmacêutica de anticorpo de pd-l1 e uso da mesma BR112019023846A2 (pt)

Applications Claiming Priority (2)

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

Publications (1)

Publication Number Publication Date
BR112019023846A2 true BR112019023846A2 (pt) 2020-06-09

Family

ID=64273337

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112019023846A BR112019023846A2 (pt) 2017-05-16 2018-05-15 composição farmacêutica de anticorpo de pd-l1 e uso da mesma

Country Status (13)

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

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6983371B2 (ja) * 2015-11-17 2021-12-17 スーヂョウ サンケイディア バイオファーマスーティカルズ カンパニー リミテッド 抗pd−l1抗体、その抗原結合フラグメントおよびその医療用途
US20230287122A1 (en) * 2018-11-29 2023-09-14 Harbour Biomed Therapeutics Limited Anti-pd-l1 antibody preparation
CN113518823A (zh) * 2019-01-07 2021-10-19 托马斯杰斐逊大学 多功能的融合蛋白及其用途
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
EP3998081A4 (en) 2019-07-05 2023-07-12 Ono Pharmaceutical Co., Ltd. TREATMENT OF BLOOD CANCER WITH PD-1/CD3 DUAL SPECIFICITY PROTEIN
EP4011918A4 (en) 2019-08-08 2023-08-23 ONO Pharmaceutical Co., Ltd. DUAL SPECIFIC PROTEIN
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
AR126614A1 (es) * 2021-07-29 2023-10-25 Shanghai Junshi Biosciences Co Ltd Composición farmacéutica de anticuerpo anti-pd-1 y uso de la misma
TW202333789A (zh) * 2022-01-05 2023-09-01 大陸商上海邁晉生物醫藥科技有限公司 一種包含抗FXI/FXIa抗體的醫藥組成物及其用途

Family Cites Families (12)

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BR9609743A (pt) 1995-07-27 1999-03-02 Genentech Inc Formulação reconstituída estável método para a preparação de uma formulação artigo manufaturado e uso da formação
ES2190087T3 (es) * 1997-06-13 2003-07-16 Genentech Inc Formulacion estabilizada de un anticuerpo.
ATE556591T1 (de) 2001-11-08 2012-05-15 Abbott Biotherapeutics Corp Stabile pharmazeutische flüssigformulierung von igg-antikörpern
BRPI0613361A2 (pt) 2005-07-01 2011-01-04 Medarex Inc anticorpo monoclonal humano isolado, composição, imunoconjugado, molécula biespecìfica, molécula de ácido nucleico isolada, vetor de expressão, célula hospedeira, camundongo transgênico, método para modular uma resposta imune num indivìduo, método para inibir crescimento de células tumorais num indivìduo, método para tratar uma doença infecciosa num indivìduo, método para aumentar uma resposta imune a um antìgeno num indivìduo, método para tratar ou prevenir uma doença inflamatória num indivìduo e método para preparar o anticorpo anti-pd-l1
KR20210060670A (ko) 2008-12-09 2021-05-26 제넨테크, 인크. 항-pd-l1 항체 및 t 세포 기능을 향상시키기 위한 그의 용도
BR122021025338B1 (pt) 2009-11-24 2023-03-14 Medimmune Limited Anticorpo isolado ou fragmento de ligação do mesmo contra b7-h1, composição farmacêutica e seus usos
KR102031020B1 (ko) 2011-03-31 2019-10-14 머크 샤프 앤드 돔 코포레이션 인간 프로그램화된 사멸 수용체 pd-1에 대한 항체의 안정한 제제 및 관련된 치료
PE20160541A1 (es) * 2013-09-27 2016-06-03 Genentech Inc Formulaciones de anticuerpos anti-pdl1
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JP6983371B2 (ja) 2015-11-17 2021-12-17 スーヂョウ サンケイディア バイオファーマスーティカルズ カンパニー リミテッド 抗pd−l1抗体、その抗原結合フラグメントおよびその医療用途
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Also Published As

Publication number Publication date
KR102623679B1 (ko) 2024-01-11
WO2018210230A8 (zh) 2019-09-26
JP7263256B6 (ja) 2023-07-24
US20200069800A1 (en) 2020-03-05
RU2019139093A (ru) 2021-06-16
CN110198739B (zh) 2023-04-04
EP3626266A1 (en) 2020-03-25
CN110198739A (zh) 2019-09-03
WO2018210230A1 (zh) 2018-11-22
JP2020520939A (ja) 2020-07-16
CA3062487A1 (en) 2018-11-22
RU2766590C2 (ru) 2022-03-15
KR20200005650A (ko) 2020-01-15
RU2019139093A3 (pt) 2021-08-10
US11654194B2 (en) 2023-05-23
TWI734916B (zh) 2021-08-01
EP3626266A4 (en) 2021-04-07
JP7263256B2 (ja) 2023-04-24
AU2018267843A1 (en) 2019-12-12
TW201900211A (zh) 2019-01-01
MY195465A (en) 2023-01-25
MX2019013751A (es) 2020-01-15

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