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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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
seq
concentration
monoclonal antibody
humanized monoclonal
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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
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    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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    • A61K47/00—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
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    • 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

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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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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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
CN115697407A (zh) * 2020-06-02 2023-02-03 正大天晴药业集团股份有限公司 c-Met激酶抑制剂和抗PD-L1抗体的联用药物组合物
TW202241513A (zh) * 2021-04-21 2022-11-01 大陸商江蘇恆瑞醫藥股份有限公司 一種包含抗體融合蛋白的醫藥組成物及其用途
CN116019907A (zh) * 2021-07-29 2023-04-28 上海君实生物医药科技股份有限公司 抗pd-1抗体药物组合物及其用途

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

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