HCV race in China
How Ascletis could beat Gilead to market for HCV in China
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.
The danoprevir program is being closely tracked in China, because Ascletis licensed China rights to the product from Roche. The deal was one of the first cross-border collaborations to include local manufacturing, which is what allows danoprevir to benefit from China's regulatory pathway for domestic drugs.