Xinhua Insight: Roche strives for breakthrough in hepatitis cure in China

Scientists working for Roche, the world's largest biotech company, at its Shanghai innovation center have made "tremendous progress" in developing drugs that might soon cure hepatitis B, a prevalent disease now requiring lifelong medication.

"We don't know whether they will work on humans yet, but we have conducted successful animal experiments and it looks very promising," said Dr. Christoph Franz, chairman of the Switzerland-based company.

Franz revealed in an exclusive interview with Xinhua that the researchers will soon start human trials of the drugs, which are being patented around the world.

The new drugs are based on mechanisms that both inhibit the viral target and activate the immune system to fight the hepatitis B virus (HBV), Franz explained.

"If the initial clinical trials are successful, it will take at least another three or four years to bring the new candidates to the market," Franz said. "But it's also very risky in the pharmaceutical industry, as nine out of 10 medicines that are taken to clinical trials fail."

An estimated 240 million people around the world are chronic sufferers of hepatitis B and more than 780,000 die every year due to complications, including cirrhosis and liver cancer, according to the World Health Organization (WHO).

In China, more than 90 million people have chronic hepatitis B. Aside from the burden of medical costs, they also face discrimination from school enrollment to employment.

"It is our ambition to create drugs here in Shanghai that will cure the disease on a global scale," Franz said, adding that China is the company's fourth innovation base, following the United States, Switzerland and Germany.

Roche set up a pharmaceutical branch in Shanghai in 1994, and has developed a whole value chain here that covers research and development, manufacturing and sales.

It established the first foreign-funded R&D center in Shanghai in 2004 and announced at the end of last year that it would invest 860 million yuan in building a new laboratory building for the center.

The detailed design of the new building, to be built at a site a ten-minute drive from the old one, is close to complete. Construction will start in November and is expected to be finished in 2018.

"It underscores the importance we attach to China because of its huge talent pool and good academic education," Franz said, adding the new facility will spur collaboration between Roche and local research institutions and help attract the best talents to the country.

Relying purely on innovation, Roche produces no generic or biosimilar drugs. It spent 9.3 billion Swiss francs, or 20 percent of its turnover, last year on research and development, ranking it among top five R&D investors worldwide in any industry.

However, China is more than an innovation base for Roche. Its growing wealth and aging population gives it huge market potential to the pharmaceutical industry.

"It is of utmost interest that the latest and most innovative drugs are available in the Chinese market, and we are very pleased to see the progress the government is making to speed up drug approval," said Franz.

"My aspiration is to introduce a new drug in China on the same day as in the United States and Europe."

However it can take up to five years for a drug to pass separate clinical trials in each country and the approval process is sometimes lengthy.

With both pharmaceutical and diagnostic businesses under the same roof, Roche stresses personalized healthcare as its core strategy.

"About 60 percent of our new medicines under development have companion diagnostics," Franz said, citing Herceptin, a successful targeted cancer drug effective for treating HER2-positive breast cancer as an example.

Patients are tested first to detect the over-expression of HER2 before getting a prescription, which will help improve effectiveness of the treatment, he explained.

But affordability is still an issue in many countries, including China. "We have reached separate agreements with provincial governments to make some cancer drugs available to their citizens. We hope that some of our cancer drugs will be added to the National Reimbursement Drug List (NRDL) when it is updated in the near future," Franz said.

Herceptin, which supports a survival rate of 80 percent according to an 11-year follow-up survey, is now reimbursed in 11 provinces with a total population of 350 million.

However, even in one province, the reimbursement schemes can vary from city to city. "In Zhejiang, the reimbursement ratio ranges from 50 percent to 80 percent in different cities, depending on each city's budget," Franz explained.

To improve affordability, Roche also works with private insurance companies and offers free medicines in patient assistance programs.

"We are optimistic that with joint efforts from multiple stakeholders, including the government, insurance companies and Roche itself, more and more patients in China will have access to quality treatments," Franz said. Endi