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