Research and development of innovative antibody-based drugs
10.16438/j.0513-4870.2017-0973
- VernacularTitle:关于创新型抗体药物药学评价的思考
- Author:
Bo-ning LIU
1
;
Jian-hui LUO
1
Author Information
1. Center for Drug Evaluation, China Food and Drug Administration, Beijing 100038, China
- Publication Type:REVIEWS
- Keywords:
innovative antibodies;
antibody engineering;
antibody-drug conjugates;
bispecific antibodies;
programmed cell death 1 receptor
- From:
Acta Pharmaceutica Sinica
2017;52(12):1811-1819
- CountryChina
- Language:Chinese
-
Abstract:
With the development of antibody manufacturing technology and improvement in new drug research and development (R&D) capabilities in domestic industry, more and more innovative antibody-based drugs were registered at the Investigational New Drug (IND). This type of drugs could be divided into three categories:new sequence antibodies (biobetter or new target antibodies), bispecific antibodies (or antibody cocktails), and antibody drug conjugates. Comparing with biosimilar antibodies, the innovative antibodies R&D was characterized by some significant features including "innovation", "clinical phase-appropriate" and "progressing". The minimum requirements of Chemical, Manufacturing and Control (CMC) content for innovative antibodies were obviously different from biosimilar antibodies. Here, the recent progress of antibody engineering and IND date of innovative antibodies in domestic are summarized. The general regulatory requirement and special considerations for representative innovative antibodies were proposed. Some common problems concerning innovative antibodies R&D are discussed.
