双特异性抗体在癌症治疗中:目标选择和监管要求
Yanze Sun1,2,3, Xinmiao Yu1,2,3, Xiao Wang1,2,3
1State Key Laboratory of Natural Medicines and Jiangsu Key Laboratory of Drug Design and Optimization, China Pharmaceutical University, Nanjing 210009, China.
Acta pharmaceutica Sinica. B
|September 18, 2023
概括
双特异性抗体 (bsAbs) 在癌症治疗中比单克隆抗体 (mAbs) 具有优势. 本综述对bsAbs进行了分类,分析了目标选择趋势,并比较了美国和中国的发展指南,以促进多样性和资源效率.
科学领域:
- 免疫治疗是一种免疫疗法.
- 在瘤学瘤学.
- 生物技术是生物技术.
背景情况:
- 双特异抗体 (bsAb) 开发的快速进步导致了新的结构和向组合.
- 美国和中国已经发布了 bsAb 开发的行业指南.
- 对于当前的bsAbs来说,目标选择的显著相似性可能会阻碍发育多样性.
研究的目的:
- 通过结构和标选择来分类用于癌症治疗的双特异抗体 (bsAbs).
- 与单克隆抗体 (mAbs) 相比,研究bsAbs的优势.
- 分析目标选择偏好,并比较美国和中国对BSAb开发的监管准则.
主要方法:
- 数据库研究以确定可用的bsAb组合及其目标偏好.
- 基于结构特征和癌症治疗中目标选择的bsAbs的分类.
- 对美国和中国对双特异抗体开发的监管指南进行比较分析.
主要成果:
- 在现有的bsAb组合中确定了普遍的目标选择模式.
- 突出了当前的bsAb发展战略中的潜在冗余和低效.
- 提供了对美国和中国 bsAbs. 监管框架的比较概述.
结论:
- 双特异性抗体 (bsAbs) 在癌症治疗中比单克隆抗体 (mAbs) 具有显著的优势.
- 对目标选择的分析表明,有机会进行更合理和多样化的BSB开发,避免资源浪费.
- 国际准则的比较为优化未来的BSB发展战略提供了有价值的参考.
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