SHANGHAI – The latest Chinese biopharma to receive a generous round of financing, Ascletis Pharmaceuticals Co. Ltd., of Hangzhou and Shaoxing, received $100 million from China-based venture capital firms.
“This $100 million series B financing at the beginning of the new year will definitely bring an extraordinary 2017 for Ascletis,” said Jinzi Wu, Ascletis founder, president and CEO. “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.”
In particular, Ascletis looks set to beat Foster City, Calif.-based Gilead Sciences Inc. to the local market with two hepatitis C virus (HCV) treatments similar to Harvoni (sofosbuvir/ledipasvir) and Sovaldi (sofosbuvir). The CDE granted versions of Gilead’s Harvoni and Sovaldi priority review in April. However, Ascletis’ candidates are likely to be more accessible and closer to reaching China’s estimated 15 million HCV patients, which currently have access only to painful interferon treatments or must travel abroad to get hold of Gilead’s drugs.
“The NDA filing for danoprevir was recently accepted by CFDA, and we are confident that Ascletis will be among the first batch to launch [an] HCV treatment in China. Our second direct-acting antiviral (DAA), ravidasvir (ASC16) has been granted priority review,” Jianjiong Wang, associate director, general affairs, Ascletis told BioWorld Today.
It is estimated that more than 3 percent of the population is living with HCV, making it the fourth most commonly reported infectious disease in China. Many remain undiagnosed because acute infection is asymptomatic and awareness of the disease is low. In 2010, 307,661 people worldwide died from hepatitis C; in China, 43,781 people died, according to the World Hepatitis Alliance.
The current standard of care in China is pegylated interferon (PEG-IFN) plus ribavirin. Ascletis hopes to offer two DAA regimens for Chinese patients with chronic hepatitis C: a triple therapy and an all-oral, interferon-free therapy. According to Ascletis, the clinical study results show that with 12-week treatment, the cure rate (SVR12) of both regimens exceeded 95 percent in genotype 1 chronic HCV patients.
Ascletis’ interferon-free regimen contains ASC08, known as dapovenir, a second-generation HCV NS3/4A protease inhibitor in-licensed from Basel, Switzerland-based Roche Holding AG, and ASC16, a potentially best-in-class NS5A inhibitor in-licensed from Presidio Pharmaceuticals Inc., of San Francisco. (See BioWorld Today, Nov, 19, 2014.)
The recent injection of capital will be used to help build a sales force in anticipation of dapovenir getting the greenlight from regulators.
Ascletis is also looking to expand its product portfolio to other liver disease indications beyond HCV. Unlike other Chinese biopharmas that have pipelines covering a variety of diseases, Ascletis specializes in discovering, developing and commercializing new treatments only for liver diseases. But like many Chinese biopharmas, it has global ambitions.
“We will expand our liver disease pipeline to provide more high quality medicines for Chinese and global markets,” said Wu.
The latest round of financing included series A lead investor C-Bridge Capital, along with earlier investors Goldman Sachs and Tasly Pharmaceutical. The round also brought on board new investors Qianhai Equity Investment FOF, Focus Media Jiangnanchun Foundation and Fubon Financial.
In the second half of 2015, Ascletis secured $55 million in series A financing led by C-Bridge Capital and Goldman Sachs. (See BioWorld Today, Sept. 10, 2015, and Dec. 3, 2015.)
C-Bridge is a late-stage health care fund with Chinese pharmaceutical companies, foundations and sovereign funds as limited partners. It is the more mature sibling to I-Bridge, an incubator fund for health care startups. (See BioWorld Today, Dec. 16, 2015.)
In December 2015, when Goldman Sachs provided Ascletis with $20 million, the biopharma announced its intentions to go public. Ascletis said it is still evaluating options for where and when to IPO.
Ascletis has four late-stage candidates in its portfolio. In addition to danoprevir (ASC08) and ravidasvir (ASC16), it is developing ASC06, a clinical-stage RNAi therapeutic for the treatment of liver cancers (licensed from Alnylam Pharmaceuticals Inc.), and ASC09, a phase IIa-completed HIV protease inhibitor (licensed from Janssen, a Johnson & Johnson company).