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By analyzing the application and approval of new chemical drugs from 2016 to 2021, this paper compares and analyzes the distribution of treatment fields, statistics of improved dosage forms, and priority review and approval data of new chemical drugs, so as to provide ideas and reference for the research and development of new chemical drugs. The results shows that in the aspect of R&D classification, choosing classes 2.2 and 2.4 improved new drugs for the treatment often leads to higher registration success rate, and its R&D risk and technical difficulty are relatively low, which can be the focus of future research and development. In the field of treatment, anti-tumor drugs, immune function regulating drugs, nervous system drugs, etc., are hot spots of R&D for improved new drugs, which are in line with China's policy orientation. In the aspect of dosage form selection, high-end preparation technology can be used as the entry point for the research and development of class 2.2 improved new drugs. In terms of examination and approval rate, "piling up" declaration of varieties should be avoided such as paclitaxel polymer micelles for injection.
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| 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 |
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