Chinese biotech Ascletis has raised $100 million in a second-round financing as it prepares for the launch of its first commercial product.
Hangzhou-based Ascletis is vying to become the first to claim approval for an interferon-free hepatitis C virus combination therapy in China, and says the cash injection will be used to expand its product portfolio into other areas such as hepatitis B virus, as well as build its sales force.
Ascletis is racing with Gilead Sciences to bring the first direct-acting antiviral (DAA) HCV therapies to the Chinese market, along with other contenders that include Bristol-Myers Squibb and Johnson & Johnson/AbbVie. All of those companies are running trials in China while negotiating with the Chinese government on pricing and access deals.
While Gilead has been at the forefront of developing the new class with drugs like Sovaldi and Harvoni, it did not target China initially, only pressing the accelerator there earlier this year after the China Food and Drug Administration (CFDA) pledged to fast-track DAAs through the review process.
China's standard of care for HCV is currently a 48-week regimen of peginterferon with ribavirin, a hard-to-tolerate therapy that prompts more affluent patients to head abroad to seek out shorter and more effective DAA therapies in other countries.
In trials reported last year, Ascletis' danoprevir/ravidasvir combination was able to clear HCV in 100% of Chinese patients with genotype 1b HCV, the most prevalent form of the virus in China, affecting nearly two-thirds of the country's 30 million estimated cases.
Ascletis' HCV protease inhibitor danoprevir is currently under regulatory review by the CFDA, while NS5A inhibitor ravidasvir has been awarded priority review status.
The new $100 million fundraising round was led by C-Bridge Capital and included several new investors as well as longstanding Ascletis backers Goldman Sachs and Tasly Pharmaceutical. Ascletis raised $55 million in Series A financing led by C-Bridge and Goldman Sachs in 2015.
The latest cash injection "will definitely bring an extraordinary 2017 for Ascletis," said the firm's chief executive Jinzi Wu.
"We aim to make the historical step of being the first Chinese company to launch in 2017 an innovative medicine treating [chronic hepatitis C] patients in China. We will expand our liver disease pipeline to provide more high quality medicines for Chinese and global markets."