Bispecific antibodies in cancer therapy: Target selection and regulatory requirements

被引：15

作者：

Sun, Yanze ^{[1
,2
,3
,4
]}

Yu, Xinmiao ^{[1
,2
,3
,4
]}

Wang, Xiao ^{[1
,2
,3
,4
]}

Yuan, Kai ^{[1
,2
,3
,4
]}

Wang, Gefei ^{[1
,2
,3
,4
]}

Hu, Lingrong ^{[1
,2
,3
,4
]}

Zhang, Guoyu ^{[1
,2
,3
,4
]}

Pei, Wenli ^{[1
,2
,3
,4
]}

Wang, Liping ^{[1
,2
,3
,4
]}

Sun, Chengliang ^{[1
,2
,3
,4
]}

Yang, Peng ^{[1
,2
,3
,4
]}

机构：

[1] China Pharmaceut Univ, State Key Lab Nat Med, Nanjing 210009, Peoples R China

[2] China Pharmaceut Univ, Jiangsu Key Lab Drug Design & Optimizat, Nanjing 210009, Peoples R China

[3] China Pharmaceut Univ, Sch Pharm, Dept Med Chem, Nanjing 211198, Peoples R China

[4] China Pharmaceut Univ, Inst Innovat Drug Discovery & Dev, Nanjing 211198, Peoples R China

来源：

ACTA PHARMACEUTICA SINICA B | 2023年 / 13卷 / 09期

基金：

中国国家自然科学基金;

关键词：

Bispecific antibody; Target selection; Structure; Regulatory guidance; Cancer immunotherapy; Clinical trials; Oncology; Mechanism; BREAST-CANCER; IMMUNE CHECKPOINTS; ANTITUMOR-ACTIVITY; EGFR; ANGIOPOIETIN-2; TRASTUZUMAB; SAFETY; CHEMOTHERAPY; TETRAVALENT; MECHANISMS;

D O I：

10.1016/j.apsb.2023.05.023

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

In recent years, the development of bispecific antibodies (bsAbs) has been rapid, with many new structures and target combinations being created. The boom in bsAbs has led to the successive issu-ance of industry guidance for their development in the US and China. However, there is a high degree of similarity in target selection, which could affect the development of diversity in bsAbs. This review pre-sents a classification of various bsAbs for cancer therapy based on structure and target selection and ex-amines the advantages of bsAbs over monoclonal antibodies (mAbs). Through database research, we have identified the preferences of available bsAbs combinations, suggesting rational target selection options and warning of potential wastage of medical resources. We have also compared the US and Chinese guidelines for bsAbs in order to provide a reference for their development.(c) 2023 Chinese Pharmaceutical Association and Institute of Materia Medica, Chinese Academy of Medical Sciences. Production and hosting by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

引用

页码：3583 / 3597

页数：15

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