New Drug Application Enthusiasm Rising China's R & D Outsourcing Business Will Continue to Expand


Release time:

2019-09-26

In the first half of 2019, the overall enthusiasm for new drug declaration in China was high, and the total number of applications for clinical trials (IND) of Class 1 chemical drugs, Class 1 therapeutic biological products, and imported chemical drugs/biological products showed an upward trend. According to incomplete statistics, the number of Class 1 chemical drug I ND accepted in the first half of 2019 reached 197, an increase of 72.81 percent over the second half of 2018, involving a total of 69 varieties. The number of new drug applications (NDA) for Class 1 chemical drugs declined slightly, with a total of 9 acceptance numbers, involving 4 varieties.

Compared with the second half of 2018, the number of I ND acceptance of Class 1 therapeutic biological products increased significantly in the first half of 2019, reaching 54 (up 20%); The number of IND acceptance of Class 2 and Class 15 therapeutic biological products reached 4 and 2 respectively. In the first half of 2019, the number of NDA acceptance of Class 1, Class 2 and Class 15 therapeutic biological products was 3, 3 and 13 respectively, of which the number of NDA acceptance numbers of Class 15 therapeutic biological products increased by 550 compared with the second half of last year.

In the first half of 2019, the number of IND declarations for imported chemical drugs/biological products increased significantly compared with the same period last year. The number of IND applications for imported chemical drugs reached 149, an increase of 98.67 percent over the same period last year, and the number of IND applications for imported biological products reached 59, an increase of 227.78 percent over the same period last year.

In the transition period from imitation to innovation in the domestic pharmaceutical market, major pharmaceutical companies continue to increase investment in research and development, and the enthusiasm for drug declaration continues unabated. Most of the domestic pharmaceutical enterprises have been engaged in generic drug research and development for a long time and lack of innovative technology and experience, CRO enterprises will assist pharmaceutical enterprises to greatly shorten the time of new drug research and development, it is expected that the penetration rate of domestic pharmaceutical outsourcing business will continue to improve in the future. At the same time, China's market is the major multinational pharmaceutical enterprises focus on, overseas innovative drugs in China to actively carry out clinical trial declaration will be the general trend, domestic CRO enterprises in the future will undertake more multinational pharmaceutical enterprises new drug research and development projects.