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| Ascletis CEO Jinzi Wu |
China-based Ascletis Pharmaceuticals has notched up a first with plans for Phase III trials of danoprevir (ASC08) and ASC16 (PPI-668) to treat chronic hepatitis C in China and Taiwan. If successful, the trials could represent a milestone that could reach an estimated patient population of 30 million to 40 million, the highest worldwide.
Applications were made with the China FDA and Taiwan FDA for the candidates, with danoprevir licenses from Roche ($RHHBY) (which halted work in 2013) and ASC16 licensed from Presidio Pharmaceuticals. An Ascletis spokesman told FiercePharmaAsia that the Taiwan approval is expected within three months and that China's Center for Drug Evaluation could take as long as the first quarter of 2016.
The trials would possibly pip other efforts by companies to enter the China market with hepatitis C therapies, most notably Gilead Sciences ($GILD) which this month lost a patent application for a prodrug component of its treatment, Sovaldi (sofosbuvir), in China after the State Intellectual Property Office reportedly rejected it.
Gilead has Phase III Sovaldi trials in China as part of a multi-region study, according to Clinicaltrials.gov, which said the work is ongoing, but not recruiting participants. A separate trial to treat Chinese patients in China and Hong Kong who are interferon-ineligible or intolerant, however is recruiting patients, according to Clinicaltrials.gov.
The focus in China for chronic hepatitis C is genotype 1b, experts say, with nearly two thirds of the estimated cases in that category. This week, AbbVie's ($ABBV) said data on a Viekirax and Exviera cocktail showed a 100% sustained response rate in genotype 1b patients with cirrhosis.
But Ascletis would be the first Chinese-based firm to bring a treatment through trials and, if approved, would be a clear leader in the race to bring an approved drug to the market.
ASC08 has finished Phase II trials in Taiwan in positive data for cure rates, according to Ascletis, making it possible for the China FDA to consider accepting the data and results under a 2014 agreement that has not be fully tested.
Another plus for Ascletis is that the drugs would fall under the innovative domestic category pushed by Beijing and the possibility it could be listed for reimbursement. A Chinese drug also potentially challenges an initiative by Gilead to allow 7 Indian manufacturers to make cheaper versions of Sovaldi at $300 a bottle and sell to more than 90 developing countries.
But other large emerging markets with high hepatitis C infection rates such as China, Russia, Brazil, Mexico and Ukraine are not included. It is also important to note that when Gilead lost a patent component application for Viread, the company eventually moved to allow generic versions worldwide.
Ascletis did not offer any pricing hints in its press release and the spokesman declined to comment on costs.
- here's the Ascletis release (PDF)
- and Clinicaltrials.gov info on NCT02021643 and NCT02473211