With a simplified approval process, drug companies are now getting first approvals for new therapies in China.
The Chinese market for branded drugs could rival or exceed that of the US market within just a few decades, and the potential for significant growth is attracting the attention of drug developers. Until recently, however, multinational firms had difficulty getting new drugs approved in China.
That changed in 2017 when the Chinese government simplified the drug approval process – eliminating the need for the repetition of drug trials in China - with the hope of bringing new therapies to Chinese patients. China also eliminated tariffs on 28 imported drugs and lengthened patent protection to deflect criticism that its intellectual property protections were too lax. In addition, most Chinese people have public medical insurance, and many are willing to pay for the latest western medicines themselves.
Pharma companies are responding to this demand, with some filing for novel drug approvals in China before the US and Europe. AstraZeneca, for instance, took its anemia medicine, roxadust — which it is developing with FibroGen, to China first. China’s FDA gave it priority review, and AstraZeneca expects approval before the end of 2018. The company doesn’t plan to file in the US until the first half of 2019.