Ascletis gets $20M from Goldman in race to China HCV approval

Hangzhou-based biotech Ascletis Pharmaceuticals has raised $20 million in funding from Goldman Sachs ($GS), gearing up as it looks to win pole position in the China hepatitis C treatment market and possibly tap the capital markets.

In September, the company 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 latest funds from Goldman, according to a press release, would also help the company build R&D efforts for a company founded in 2011 with $100 million in startup capital and now with four in-licensed candidates, covering oncology and infectious diseases.

Ascletis CEO Jinzi Wu

"2015 is an important year in the history of Ascletis, as we continue to deliver results in the HCV field, and move forward with the construction of our manufacturing facility," Jinzi Wu, founder, president and CEO, said in a statement.

"In the future, we will continue to develop our existing products and explore new opportunities with domestic and global partners through a flexible, open and innovative business model, with the aim of effectively delivering new products to China and the rest of the world."

In September, Ascletis won approval to begin a Phase II trial of danoprevir (ASC08) in Taiwan in combination with danoprevir, ASC16 (PPI-668), for an interferon-free HCV treatment. That followed a June clinical trial application in Taiwan following the completion of a successful interferon-containing Phase II trial with ASC08. Danoprevir was licensed for China rights from Roche ($RHHBY) (which halted work in 2013) and ASC16 licensed from Presidio Pharmaceuticals.

The Phase II trial started in September, while a clinical trial application rests with China FDA, marking it as the first Chinese company to seek a clinical trial in-country for an interferon-free HCV treatment.

Pricing for the HCV treatment, if approved, in China is in sharp focus as Gilead ($GILD) is still working with Chinese regulators on approval for HCV treatment Sovaldi and is in talks separately with China on possible pricing, the company recently told FiercePharmaAsia.

Ascletis hopes to start a Phase III trial of ASC08 in 2016 in China with marketing as early as 2017, with ASC16 slated by 2018.

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.

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 with trials in both Taiwan and mainland China for HCV and which has candidates for the treatment of liver cancer licensed from Alnylam Pharmaceuticals ($ALNY) as well as licensed from Johnson & Johnson ($JNJ) unit Janssen, ASC09, aimed at HIV.

- here's the release