Development of Monoclonal Antibodies in China: Overview and Prospects
Table 1
Launched mAbs products in China.
Number
Generic
Trade
Company
Year
Therapeutic category
Target
Type
R&D
Technology source
1
Murine mAb against Human CD3 Antigen of T Lymphocyte Injection
N/A
WIBP
1999
Treatment and prevention for acute rejection of patients received kidney and organ transplant
CD3
Murine
Me-too
Internal R&D
2
Murine mAb against Human Interleukin-8 Cream
Enboke
Asia Space
2003
For the treatment of psoriasis vulgaris and eczema
IL-8
Murine
Me-too
Anogen-Yes, CA
3
Iodine (131I) metuximab injection
Licartin
Chengdu Huasun
2006
For the treatment of primary liver cancer can not be resected with surgery or primary liver cancer relapse and advanced liver cancer not suitable for TACE treatment or ineffective after TACE treatment
CD147
Murine
Me-too
Fourth Military Medical University, CN
4
Iodine (131I) tumor necrosis therapy mAb injection
Weimeisheng
Shanghai Mei-En
2006
For the radio immunotherapy treatment of advanced lung cancer can not be controlled by radioactive chemotherapy or advanced lung cancer relapse
Intracellular DNA
Chimeric
Me-better
University Of Southern California (USC), USA
5
Nimotuzumab injection
Taixinsheng
BioTech
2008
For the radiotherapy treatment of III/IV period of nasopharyngeal with positive expression of epidermal growth factor receptor
EGFR
Humanized
Me-better
Center of Molecular Immunology (CIM), CU
6
Recombinant Humanized Anti-CD25 mAb Injection
Jiannipai
CPGJ
2011
For the prevention of acute rejection after kidney transparent
CD25
Humanized
Me-better
Second Military Medical University, CN
7
Recombinant Human Tumor Necrosis Factor- Receptor II: IgG Fc Fusion Protein Injection
Yisaipu
CPGJ
2005
(1) For the treatment of moderate and severe active rheumatoid arthritis (2) For the treatment of moderate and severe plaque psoriasis patients aged at least 18 (3) For the treatment of active ankylosing spondylitis.
TNF
Recombinant fusion protein
Me-better
Self-development
8
Recombinant Human TNF Receptor-IgG Fusion Protein Injection
Qiangke
Shanghai Celgen
2011
(1) For the treatment of moderate and severe active rheumatoid arthritis (2) For the treatment of moderate and severe plaque psoriasis patients aged at least 18 (3) For the treatment of active ankylosing spondylitis
TNF
Recombinant fusion protein
Me-too
Input from US
Notes: each row of the table represents kinds of information about mAbs products approved in China. “Trade” is brand name of drug selling in Chinese market. “R&D Type” means that medicines are classified according to different technology and skill levels. “WIBP” is Wuhan Institute of Biological Products, Ltd. “CPGJ” is Shanghai CP Guojian Pharmaceutical Co., Ltd. Source: http://www.sda.gov.cn/WS01/CL0001/; author’s analysis.
