ARTICLE | Product Development
HCV race in China
How Ascletis could beat Gilead to market for HCV in China
April 13, 2015 7:00 AM UTC
Armed with positive Phase II HCV data, Ascletis Pharmaceuticals Co. Ltd. may be able to leapfrog Gilead Sciences Inc. to market in China even though both companies are now seeking approval to begin Phase III trials.
The reason is that Ascletis can benefit from two regulatory pathways in China: one that expedites approvals to begin trials for domestic companies, and another that could delay submissions of NDAs and BLAs for multinationals by two to four years...