SHANGHAI - The U.S. Food and Drug Administration has given the green light for Jiangsu Hengrui Medicine to conduct Phase I clinical trials on an innovative diabetes drug in the U.S. This is the first time FDA has approved an application to stage a clinical trial of a China-discovered, synthesized drug.

The medicine, Retagliptin , is described as an improved version of Merck's Januvia (sitagliptin), a member of the DPP-4 inhibitor class of drugs prescribed for type 2 diabetes patients who are not on insulin ([A#0071017001]). Hengrui has applied for patents on the drug inside China and abroad.

"The reason Hengrui Medicine is widely recognized in the market is not only because of its stable and sustained performance and growth, but also due to its rich reserve of innovative drugs," said Ge Zhen, an analyst with the Guangzhou-based GF Securities. "The company has been engaged in R&D on innovative drugs since 2004."

Hengrui submitted an application to hold clinical trials in the U.S. in July of this year, but has not yet applied to China's State FDA to stage concurrent trials inside China.

"We expect Phase I clinical trials will be completed in the first quarter of 2010, and all three phases of clinical trials are expected to take five years," said Ge. "We are optimistic about the prospects for the company's ability to innovate and become more international."

Ge added that staging clinical trials in the US will strengthen Hengrui's R&D and will boost investor confidence in the company.

"The preclinical trial results have demonstrated the drug's efficacy, safety and other key indicators are better than similar products from multinational pharmaceutical companies; the company will actively advance to full clinical trials," said Ge. "But the risk is that it is still possible to fail the clinical trials, which will incur a huge expense for the company."

American drug maker Eli Lilly started marketing its diabetes drug Byetta (exenatide) in China in August of this year. Eli Lilly has already sold two insulin products, Humulin and Humalog , in China.

In 2008, Denmark's Novo Nordisk, French drug maker Sanofi-Aventis and Eli Lilly accounted for about 95 percent of the high-end diabetes drug market in China.

According to a report entitled "Type 2 Diabetes in China" from Decision Resources, the value of China's type 2 diabetes drug market will more than triple by 2012.

A report entitled "The World Diabetes Market, 2007-2025: An Analysis of Diabetes Drugs and the Insulin Market," by Research and Markets, said that the top eight diabetes drugs posted sales of more than US$5 billion between October 2007 and October 2008.

- Ying Huang (pharmasianews@elsevier.com)

Chinese Pharmaceutical R&D Takes A Great Leap Forward With FDA Approved Clinical Trials In The U.S.

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