China's Ascletis Pharmaceuticals has won approval to begin a Phase II trial of danoprevir (ASC08) in Taiwan in combination with ASC16 (PPI-668) for an interferon-free HCV treatment that could also help put it in pole position in the Chinese market, the company said in a press release.
In June, Ascletis said it had made the clinical trial application in Taiwan following the completion of a successful interferon-containing Phase II trial with ASC08.
The Phase II trial is slated to start in September, while a separate clinical trail application rests with China FDA for review, marking it as the first Chinese company to seek a clinical trial in-country for an interferon-free HCV treatment.
Gilead ($GILD) is still working with Chinese regulators on approval for HCV treatment Sovaldi in China even as a June decision by China's State Intellectual Property Office rejected a portion of an application for the drug. It is also in talks separately with China on possible pricing, the company recently told FiercePharmaAsia.
Ascletis has said it expects an approved drug would compete head-to-head with Sovaldi.
The focus in China for chronic hepatitis C is genotype 1b, experts say, with nearly two-thirds of the 30 million estimated cases in that category. In August, AbbVie ($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 company 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. Danoprevir was licensed for China rights from Roche ($RHHBY) (which halted work in 2013) and ASC16 licensed from Presidio Pharmaceuticals.
China has recently eased multiregional clinical trial hurdles as part of an effort to clear nearly 20,000 medicine approval requests pending and allowing more innovative therapies to reach the market, according to a briefing by the country's State Council.
That may benefit Ascletis, which plans to conduct trials in both Taiwan and mainland China with the company saying in June that Taiwan data may bolster a China approval in early 2016.
Ascletis also has a candidate for the treatment of liver cancer licensed from Alnylam Pharmaceuticals ($ALNY) as well as a candidate licensed from Janssen, ASC09, aimed at HIV.
On Wednesday, Ascletis said it had raised $35 million in a funding round led by C-Bridge Capital, with Tasly Pharma and Singapore-based Pavilion Capital also in the round to fund pipeline expansion, global regulatory filings and GMP-certified manufacturing.
The company was founded in 2011 with $100 million in startup capital and now has four in-licensed candidates.