SHANGHAI – Chinese biotech Ascletis Inc. received $35 million in venture capital investment and kicked off a Taiwan phase II trial for an interferon (IFN)-free hepatitis C regimen, all in a matter of a week.

China has a sizable population living with the hepatitis C virus (HCV) but the remarkably effective treatments, Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir) from Gilead Sciences Inc., are not available to patients here. Ascletis looks to be closer than Gilead to getting both triple and IFN-free therapies to Chinese patients.

“It is Ascletis’ vision to bring breakthrough treatments to the Chinese market,” said Jinzi J. Wu, CEO, founder and president of Ascletis. “With two direct-acting antivirals [DAAs] in the pipeline, we are developing a triple therapy [ASC08 in combination with PEG-IFN/ribavirin for 12 weeks] and an all-oral-IFN-free therapy to meet different clinical needs of the patients.”

The Taiwan trial, called EVEREST, will be conducted in six sites, and will test two DAAs, NS3/4A protease inhibitor ASC08 and NS5A inhibitor ASC16 for advanced chronic HCV. Treatment-naïve, genotype 1, noncirrhotic patients will be enrolled and dosed for 12 weeks.

The primary endpoint is sustained virologic response at 12 weeks post-treatment (SVR12).

According to Ascletis, ASC16 and ASC08 are well tolerated and have shown strong antiviral activity in prior clinical trials. The goal of combining the two inhibitors, without interferon, is to see if there is an increased antiviral efficacy and a higher barrier to resistance.

Conducting trials in Taiwan has the advantage of being timely and an opportunity to collect data on Chinese patients. In HCV, ethnicity is believed to be a factor.

Ascletis has filed with the CFDA for approval to conduct trials on the Chinese mainland, but those are still in the regulators’ queue, yet to be approved.

The trial is important for Taiwan, which like China is without a DAA on the market, but given the much greater patient population on the other side of the straits, Wu is encouraged that the data collected in Taiwan also could be relevant for approval on the mainland.

“We submit all our data to the CDE and the CFDA. They look at all data, including the U.S. data. At the DIA meeting [in Shanghai], and many CDE officers at different meetings over the past months have also said we look at global data,” said Wu.

For innovative drug developers getting through a regulatory system initially designed for generic drugs has been complicated and time consuming. However, given the recent spate of good news coming from the CFDA – such as promises to clear the clinical trial application (CTA) backlog and new rules to encourage innovation – companies like Ascletis look set to benefit. (See BioWorld Today, Aug. 26, 2015.)

Meanwhile, a refined definition for category 1.1 innovative drugs could hurt originators such as Gilead seeking to enter China with drugs already approved in other markets.

“If you look at the definition of new drugs [category 1.1], a new drug is one that is never marketed anywhere globally. They want to increase innovation so that means being the first globally. If you are not first globally, you may not get the highest priority from the reviewers,” explained Wu.

Drugmakers with approved drugs in other markets will face having to take another regulatory channel designed for generics. Multinational corporations will likely find they are delayed in terms of getting drugs on the market, chewing up their patent life.

BEYOND HCV

But greater transparency and commitment from the regulators is expected to have a positive impact on the industry overall, said Wu, who is excited to see long-waited reforms finally arrive.

Having just completed a $35 million funding round, he said that “investors also value biotech because we finally have the regulatory approval from the central government.”

The latest financing, Wu said, will be used to expand the Ascletis pipeline to areas beyond the current HCV programs into other diseases of the liver such as hepatitis B. Although he said the deals have been made for assets, they are as yet undisclosed.

“We have sufficient financing for HCV. The reason why we are doing this round of financing is we want to go beyond HCV,” said Wu.

Before the financing, Ascletis was valued at $300 million.

The investment was led by C-Bridge Capital Partners, joined by Tasly Pharmaceutical and Singapore-based Pavilion Capital, a subsidiary of Temasek Holdings.

C-Bridge is an experienced China fund, while Pavillion Capital PTE Ltd., said Wu, provides the recognition of a global fund. Tasly, a large local Chinese pharmaceutical company, can offer extensive resources and networks in China.

According to Wu, Ascletis has begun to research the public market exit options in China. Those options vary from the main markets – Hong Kong, Shanghai and Shenzhen – to the burgeoning specialty boards such as Beijing’s Third Board and Shanghai’s and Shenzhen’s plans to set up similar boards for innovative, nonrevenue-generating companies in the near future.

That is also where the Taiwan trials will come in handy.

“Most exciting to me is that we started the phase II trial in Taiwan. That is the key; when you have good data all the investors rush to you,” said Wu.

“Our data are straightforward; we cure patients,” he added. “That is very easy to understand, especially for Chinese investors. Global investors they already know the HCV story. We see a potential advantage with a therapy that can provide a cure – rather than just an improvement.”

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