Impact of China-US drug regulatory incentives on local innovative drug simultaneous development in multiple countries: An empirical study based on zanubrutinib / 中国临床药理学与治疗学

ABSTRACT

This article teases out the main regulatory incentives for innovative drugs in China and US, including optimizing the processes, setting time limits for registration, expedited programs, R&D and evaluation communication and receiving clinical data from overseas. Meanwhile, case study method is used to analyze the impact of these regulatory incentives on BeiGene's zanubrutinib, which is the first drug from Chinese Innovation Company simultaneously developed in US and China. The results show that regulatory incentives are key factors to realize simultaneous development of zanubrutinib by shortening the time of registration in both countries and reducing the costs and risks of drug development. Other domestic companies can learn from the experience of zanubrutinib, to target unmet clinical needs, to rationally use domestic and foreign regulatory policies, and to enhance communication with regulators. Domestic regulator also can provide more suggestion to companies who have the intention to develop products abroad, so that more innovative drugs developed by local companies can be on the world stage.