WO2019085982A8 - 一种抗pd-l1人源化单克隆抗体的药物组合物 - Google Patents

一种抗pd-l1人源化单克隆抗体的药物组合物 Download PDF

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Publication number
WO2019085982A8
WO2019085982A8 PCT/CN2018/113579 CN2018113579W WO2019085982A8 WO 2019085982 A8 WO2019085982 A8 WO 2019085982A8 CN 2018113579 W CN2018113579 W CN 2018113579W WO 2019085982 A8 WO2019085982 A8 WO 2019085982A8
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pharmaceutical composition
humanized monoclonal
monoclonal antibody
composition containing
antibody
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PCT/CN2018/113579
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English (en)
French (fr)
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WO2019085982A1 (zh
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李建文
程艳菊
李盈淳
赵伟
张喜全
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正大天晴药业集团南京顺欣制药有限公司
正大天晴药业集团股份有限公司
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Priority to US16/756,409 priority Critical patent/US20200237906A1/en
Priority to CN202210291458.1A priority patent/CN114632150B/zh
Priority to EP18872081.7A priority patent/EP3705134A4/en
Priority to CN201880070081.9A priority patent/CN111246886B/zh
Publication of WO2019085982A1 publication Critical patent/WO2019085982A1/zh
Publication of WO2019085982A8 publication Critical patent/WO2019085982A8/zh

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
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    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
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    • A—HUMAN NECESSITIES
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    • 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
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    • 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
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61K39/00—Medicinal preparations containing antigens or antibodies
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
    • C07K2317/90—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)
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  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
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Abstract

本发明属于抗体制剂领域，具体涉及一种抗PD-L1人源化单克隆抗体的药物组合物，所述药物组合物包含1-150mg/ml抗PD-L1人源化单克隆抗体、3-50mM缓冲液、2-150mg/ml等渗调节剂/稳定剂和0.01-0.8mg/ml表面活性剂，且pH为约4.5-6.8。该制剂阻止其中抗体的聚合物增长，同时，能长时间较好地维持抗体的生物结合活性。
PCT/CN2018/113579 2017-11-02 2018-11-02 一种抗pd-l1人源化单克隆抗体的药物组合物 WO2019085982A1 (zh)

Priority Applications (4)

Application Number Priority Date Filing Date Title
US16/756,409 US20200237906A1 (en) 2017-11-02 2018-11-02 Pharmaceutical Composition of Humanized Monoclonal Anti-PD-L1 Antibody
CN202210291458.1A CN114632150B (zh) 2017-11-02 2018-11-02 一种抗pd-l1人源化单克隆抗体的药物组合物
EP18872081.7A EP3705134A4 (en) 2017-11-02 2018-11-02 PHARMACEUTICAL COMPOSITION CONTAINING A HUMANIZED MONOCLONAL ANTIBODY ANTI-PD-L1
CN201880070081.9A CN111246886B (zh) 2017-11-02 2018-11-02 一种抗pd-l1人源化单克隆抗体的药物组合物

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201711062923.X 2017-11-02
CN201711062923 2017-11-02

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WO2019085982A1 WO2019085982A1 (zh) 2019-05-09
WO2019085982A8 true WO2019085982A8 (zh) 2020-01-30

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PCT/CN2018/113579 WO2019085982A1 (zh) 2017-11-02 2018-11-02 一种抗pd-l1人源化单克隆抗体的药物组合物

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US (1) US20200237906A1 (zh)
EP (1) EP3705134A4 (zh)
CN (2) CN114632150B (zh)
WO (1) WO2019085982A1 (zh)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11246847B2 (en) * 2019-07-18 2022-02-15 Delta-Fly Pharma, Inc. Anticancer drug effect enhancer
CN110585430B (zh) * 2019-09-29 2023-09-08 华博生物医药技术（上海）有限公司 一种人源化抗人il-17a单克隆抗体的药物组合物
EP4159238A1 (en) * 2020-06-02 2023-04-05 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Combined pharmaceutical composition of c-met kinase inhibitor and anti-pd-l1 antibody
WO2022222945A1 (zh) * 2021-04-21 2022-10-27 江苏恒瑞医药股份有限公司 一种包含抗体融合蛋白的药物组合物及其用途
CA3227991A1 (en) * 2021-07-29 2023-02-02 Shanghai Junshi Biosciences Co., Ltd. Anti-pd-1 antibody pharmaceutical composition and use thereof
WO2023174408A1 (zh) * 2022-03-18 2023-09-21 正大天晴药业集团南京顺欣制药有限公司 抗tim-3抗体与抗pd-l1抗体的药物组合
CN115925947B (zh) * 2022-09-27 2023-08-22 上海百英生物科技股份有限公司 一种亲和力成熟方法及抗人pd-l1单域抗体的亲和力成熟

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JO3000B1 (ar) * 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
CN101199845B (zh) * 2006-12-14 2012-05-23 上海国健生物技术研究院 一种稳定的抗IgE人源化单抗制剂
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
LT2691112T (lt) * 2011-03-31 2018-07-25 Merck Sharp & Dohme Corp. Stabilios antikūnų kompozicijos prieš žmogaus programuojamos mirties receptorių pd-1 ir susiję gydymo būdai
CN102961745B (zh) * 2012-09-27 2015-02-18 苏州康聚生物科技有限公司 抗体组合物制剂及其应用
SG11201602283UA (en) * 2013-09-27 2016-04-28 Genentech Inc Anti-pdl1 antibody formulations
WO2015081158A1 (en) * 2013-11-26 2015-06-04 Bristol-Myers Squibb Company Method of treating hiv by disrupting pd-1/pd-l1 signaling
WO2015088847A1 (en) * 2013-12-11 2015-06-18 Glaxosmithkline Llc Treating cancer with a combination of a pd-1 antagonist and a vegfr inhibitor
JP6909153B2 (ja) * 2014-08-05 2021-07-28 アポロミクス インコーポレイテッド 抗ｐｄ−ｌ１抗体
CN106390115A (zh) * 2015-07-29 2017-02-15 上海君实生物医药科技股份有限公司 一种人源化单克隆抗体的稳定制剂
BR112018005349A2 (zh) * 2015-09-28 2018-10-09 Suzhou Suncadia Biopharmaceuticals Co., Ltd. An anti-PD-1 antibody preparation and its application in medicine
PL3386541T3 (pl) * 2015-12-07 2021-04-06 Merck Patent Gmbh Wodna formulacja farmaceutyczna zawierającą przeciwciało anty-pd-1 awelumab
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

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Publication number Publication date
CN111246886A (zh) 2020-06-05
CN114632150A (zh) 2022-06-17
US20200237906A1 (en) 2020-07-30
WO2019085982A1 (zh) 2019-05-09
EP3705134A1 (en) 2020-09-09
CN111246886B (zh) 2022-03-15
EP3705134A4 (en) 2021-07-28
CN114632150B (zh) 2023-12-19

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