China’s Food and Drug Administration will grant priority-review status to four new hepatitis C virus (HCV) treatments, opening up its market to foreign drugmakers in a rare move that may help provide access to the estimated 10 million people living with HCV in the country, The Wall Street Journal reports.
Currently, none of the direct-acting antiviral hep C drugs that have shown up to 90 percent cure rates in the United States have been approved in China. Instead, HCV-positive people in China are either directed to use older therapies such as interferon to cure the disease, or must travel overseas to places like India or Bangladesh to access generic versions of the latest hep C treatments.
However, the tide may soon change under the new bulk fast-track action by China’s Center for Drug Evaluation. Now, drug approval applications from four Western drug companies — Gilead Sciences, AbbVie, Bristol-Myers Squibb and Janssen Pharmaceuticals — have been expedited by Chinese health authorities.
Alhough the drugs have not yet been approved, analysts believe the move is expected to propel foreign drugmakers into the world’s second-largest pharmaceuticals market over the next few months. Two Chinese companies and a Taiwanese firm will also get priority review.
The hep C drugmakers are the first foreign companies to receive priority-review status in China since the country adopted a "fast-track" designation in February 2016.