收藏切换
Consideration of antibody drug conjugates development and regulation
收藏切换
PDF
Zhong-bing ZHANG, Yang WANG, Yu BAI*
Acta Pharmaceutica Sinica | 2020, 55(8) : 1971 - 1977
Less
收藏切换
Acta Pharmaceutica Sinica | 2020, 55(8): 1971-1977
New Drug Forum
Consideration of antibody drug conjugates development and regulation
Full
Zhong-bing ZHANG, Yang WANG, Yu BAI*
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
Published: 2020-08-12 doi: 10.16438/j.0513-4870.2020-0325
Outline
收藏切换

Antibody drug conjugates (ADCs), as they combine the targetability of monoclonal antibody and cytotoxicity of small molecules, are a growing class of therapeutics for cancer. The key factor of ADCs development is the accurate selection of parameters including tumor target, monoclonal antibody, cytotoxic payload, and linkage strategy of antibody to payload. Here, we summarize the main elements in the structural design and the development of ADCs, as well as the regulatory consideration of product manufacturing and control, which would be helpful for the research and development of ADCs.

monoclonal antibody  /  antibody drug conjugate  /  cytotoxic payload  /  linker  /  marketing authorization application
Zhong-bing ZHANG, Yang WANG, Yu BAI. Consideration of antibody drug conjugates development and regulation[J]. Acta Pharmaceutica Sinica, 2020 , 55 (8) : 1971 -1977 . DOI: 10.16438/j.0513-4870.2020-0325
Year 2020 volume 55 Issue 8
PDF
239
106
Cite this Article
BibTeX
Article Info
doi: 10.16438/j.0513-4870.2020-0325
  • Receive Date:2020-03-14
  • Online Date:2026-01-21
  • Published:2020-08-12
Article Data
Affiliations
History
  • Received:2020-03-14
  • Revised:2020-04-24
Affiliations
    Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
References
Share
https://castjournals.cast.org.cn/joweb/yxxb/EN/10.16438/j.0513-4870.2020-0325
Share to
QR

Scan QR to access full text

Cite this article
BibTeX
Citations
表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
关闭全屏
  • BibTeX
  • EndNote
  • RefWorks
  • TxT