China pledges fast-track review for hep C therapies

Laboratory work

China's Center for Drug Evaluation will put hepatitis C drug candidates on a fast track review, The Wall Street Journal reports, setting the stage for approvals in the near term for an estimated 13 million patients.

China was not part of a massive licensing effort for emerging markets launched by Gilead ($GILD) in 2015 that paved the way for manufacturers mostly in India to sell its hep C blockbuster Sovaldi (sofosbuvir) at a fraction of the price in the U.S. and other mature markets.

That has meant millions of patients have lacked access to antiviral therapies in China, as well as Russia, which was outside of the agreement as well. This comes despite these new treatments having cured more than 90% of hepatitis C patients over a 12-week course for most--with many traveling to Hong Kong and nearby countries to get treatments. In China, other patients must rely on a regimen of interferon/ribavirin to treat hepatitis C.

But at least three companies are near approvals in the region.

In February, Bristol-Myers Squibb ($BMY) said Phase III clinical trial results that met the primary endpoint from an all-oral chronic hepatitis C combination trial included Chinese patients.

The BMS candidate, daclatasvir (Daklinza) and asunaprevir (Sunvepra)--long approved in Japan as well as South Korea and Taiwan--is aimed at genotype 1b, the most prevalent in China. Therapies from AbbVie ($ABBV) and Xian Janssen, a joint venture with Johnson & Johnson ($JNJ) unit Janssen Pharmaceuticals, are also in the approval process.

On top of this, Ascletis Pharmaceuticals won approval in September to start a Phase II trial of danoprevir (ASC08) in Taiwan in combination with ASC16 (PPI-668) for an interferon-free HCV treatment. The same combination is pending a review in China on clinical trials and could put the company in pole position if granted.

Pressure to speed up the approval process comes from Chinese patients who have been vocal about a lack of cutting-edge medicines across cancer and other chronic diseases.

But the faster review process will not necessarily lead to quick approvals, the WSJ noted, as most drug applications in China can take more than two years--although China FDA has moved to expand review staff and prioritize therapeutic areas in the past year.

- here's the WSJ story (sub. req.)