This page is an archive. Its content may no longer be accurate and was last updated on the original publication date. It is intended for reference and as a historical record only. For hep C questions, call Help4Hep BC at 1-888-411-7578.
SHANGHAI– China will grant four global drug companies priority-review status to launch groundbreaking new hepatitis C treatments in China, a rare move to open the lucrative market to foreign players.
China’s Food and Drug Administration expedites domestic drug applications to encourage innovation. But its lengthy drug-approval process for foreign companies means none of the direct-acting antiviral agents that have been shown to cure more than 90% of hepatitis C patients within a few months have been approved in China, which has among the highest rates of the disease in the world with an estimated 10 million people infected.
Chinese patients tired of old-generation therapies such as interferon injections have increasingly traveled overseas to access the new therapies.
Hepatitis C treatments from Gilead Sciences Inc., AbbVie Inc., Bristol-Myers Squibb Co and Janssen Pharmaceuticals Inc.’s Chinese joint venture Xian Janssen are now expected to enter the world’s second-largest pharmaceuticals market in a shorter time, according to an announcement from the Center for Drug Evaluation this week. Two domestic companies and a Taiwanese company also will get priority review-status for hepatitis C drugs.
Industry experts say priority-review status doesn’t guarantee approval but welcomed the move.