CN115484983A - 一种重组抗pd-1单克隆抗体的稳定制剂 - Google Patents

一种重组抗pd-1单克隆抗体的稳定制剂 Download PDF

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CN115484983A
CN115484983A CN202180032307.8A CN202180032307A CN115484983A CN 115484983 A CN115484983 A CN 115484983A CN 202180032307 A CN202180032307 A CN 202180032307A CN 115484983 A CN115484983 A CN 115484983A
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antibody
amino acid
acid sequence
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formulation according
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CN115484983B (zh
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胡萍
刘艳
孙春昀
淮庆茹
田绍美
陶明珍
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Sinocelltech Ltd
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Abstract

提供一种重组单克隆抗体的稳定制剂。由重组抗PD‑1单克隆抗体、缓冲液、渗透压调节剂、稳定剂和表面活性剂组成。所述药物制剂可增强抗体的稳定性,延长其在含水制剂中的有效期。

Description

PCT国内申请,说明书已公开。

Claims (14)

  1. PCT国内申请,权利要求书已公开。
CN202180032307.8A 2020-06-19 2021-06-17 一种重组抗pd-1单克隆抗体的稳定制剂 Active CN115484983B (zh)

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CN2020105661538 2020-06-19
CN202010566153 2020-06-19
PCT/CN2021/100658 WO2021254447A1 (zh) 2020-06-19 2021-06-17 一种重组抗pd-1单克隆抗体的稳定制剂

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CN115484983A true CN115484983A (zh) 2022-12-16
CN115484983B CN115484983B (zh) 2024-05-24

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US (1) US20230272106A1 (zh)
EP (1) EP4169530A1 (zh)
JP (1) JP2023529234A (zh)
KR (1) KR20230026446A (zh)
CN (1) CN115484983B (zh)
AU (1) AU2021292116A1 (zh)
BR (1) BR112022025721A2 (zh)
CA (1) CA3180463A1 (zh)
MX (1) MX2022015733A (zh)
WO (1) WO2021254447A1 (zh)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107743401A (zh) * 2015-04-17 2018-02-27 百时美施贵宝公司 包含抗pd‑1抗体和另外的抗体的组合的组合物
CN109498565A (zh) * 2018-12-27 2019-03-22 兴盟生物医药(苏州)有限公司 一种稳定的抗pd-1抗体制剂及其用途
CN109562173A (zh) * 2016-08-09 2019-04-02 信达生物制药(苏州)有限公司 Pd-1抗体制剂
CN110404066A (zh) * 2018-04-28 2019-11-05 齐鲁制药有限公司 一种抗人pd-1的单克隆抗体制剂、联合用药物及其用途
CN110787292A (zh) * 2020-01-06 2020-02-14 上海复宏汉霖生物技术股份有限公司 一种细胞程序性死亡受体1抗体制剂及其用途
CN110869002A (zh) * 2017-05-02 2020-03-06 默沙东公司 程序性死亡受体1(pd-1)抗体的稳定制剂及其使用方法
WO2020097139A1 (en) * 2018-11-07 2020-05-14 Merck Sharp & Dohme Corp. Co-formulations of anti-lag3 antibodies and anti-pd-1 antibodies

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
US11603407B2 (en) * 2017-04-06 2023-03-14 Regeneron Pharmaceuticals, Inc. Stable antibody formulation
CN111349162A (zh) * 2018-12-21 2020-06-30 神州细胞工程有限公司 人源化抗pd-1抗体及其用途

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107743401A (zh) * 2015-04-17 2018-02-27 百时美施贵宝公司 包含抗pd‑1抗体和另外的抗体的组合的组合物
CN109562173A (zh) * 2016-08-09 2019-04-02 信达生物制药(苏州)有限公司 Pd-1抗体制剂
CN110869002A (zh) * 2017-05-02 2020-03-06 默沙东公司 程序性死亡受体1(pd-1)抗体的稳定制剂及其使用方法
CN110404066A (zh) * 2018-04-28 2019-11-05 齐鲁制药有限公司 一种抗人pd-1的单克隆抗体制剂、联合用药物及其用途
WO2020097139A1 (en) * 2018-11-07 2020-05-14 Merck Sharp & Dohme Corp. Co-formulations of anti-lag3 antibodies and anti-pd-1 antibodies
CN109498565A (zh) * 2018-12-27 2019-03-22 兴盟生物医药(苏州)有限公司 一种稳定的抗pd-1抗体制剂及其用途
CN110787292A (zh) * 2020-01-06 2020-02-14 上海复宏汉霖生物技术股份有限公司 一种细胞程序性死亡受体1抗体制剂及其用途

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
KAI XING等: "Inhibitory Effect of PD-1/PD-L1 and Blockade Immunotherapy in Leukemia", COMBINATORIAL CHEMISTRY & HIGH THROUGHPUT SCREENING, vol. 25, 31 December 2022 (2022-12-31), pages 1399 - 1410 *
郭雯 等: "创新药专利精解", 31 August 2021, 知识产权出版社, pages: 308 *

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BR112022025721A2 (pt) 2023-01-03
US20230272106A1 (en) 2023-08-31
KR20230026446A (ko) 2023-02-24
CA3180463A1 (en) 2021-12-23
EP4169530A1 (en) 2023-04-26
AU2021292116A1 (en) 2023-01-05
JP2023529234A (ja) 2023-07-07
WO2021254447A1 (zh) 2021-12-23
MX2022015733A (es) 2023-01-18
CN115484983B (zh) 2024-05-24

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