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CN111246886A - 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
CN111246886A
CN111246886A CN201880070081.9A CN201880070081A CN111246886A CN 111246886 A CN111246886 A CN 111246886A CN 201880070081 A CN201880070081 A CN 201880070081A CN 111246886 A CN111246886 A CN 111246886A
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pharmaceutical composition
humanized monoclonal
monoclonal antibody
antibody
stabilizer
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CN111246886B (zh
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李建文
程艳菊
李盈淳
赵伟
张喜全
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Chia Tai Tianqing Pharmaceutical Group Co Ltd
Nanjing Shunxin Pharmaceutical Co Ltd
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Chia Tai Tianqing Pharmaceutical Group Co Ltd
Nanjing Shunxin Pharmaceutical Co Ltd
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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
    • A61K39/39533—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
    • 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
    • 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
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
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    • 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
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    • 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
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • 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)
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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。

Description

PCT国内申请，说明书已公开。

Claims (15)

  1. PCT国内申请，权利要求书已公开。
CN201880070081.9A 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 Active CN111246886B (zh)

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CN201711062923X 2017-11-02
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CN115925947A (zh) * 2022-09-27 2023-04-07 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
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

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JP6802598B1 (ja) * 2019-07-18 2020-12-16 Ｄｅｌｔａ−Ｆｌｙ Ｐｈａｒｍａ株式会社 抗がん剤の効果増強剤
WO2021037184A1 (zh) * 2019-08-30 2021-03-04 正大天晴药业集团南京顺欣制药有限公司 一种靶向PD-L1和TGF-β的融合蛋白及其用途
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
EP4159238A4 (en) * 2020-06-02 2024-08-07 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
KR20240035533A (ko) * 2021-07-09 2024-03-15 마크로제닉스, 인크. Pd-1 항체의 약학적 조성물 및 그것의 용도
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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
CN115925947A (zh) * 2022-09-27 2023-04-07 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
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

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WO2019085982A8 (zh) 2020-01-30
US12150990B2 (en) 2024-11-26
WO2019085982A1 (zh) 2019-05-09
EP3705134A1 (en) 2020-09-09
EP3705134A4 (en) 2021-07-28
CN111246886B (zh) 2022-03-15
CN114632150A (zh) 2022-06-17
US20200237906A1 (en) 2020-07-30
CN114632150B (zh) 2023-12-19

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