One step closer

A Chinese herbal medicine for liver ailments has cleared a big hurdle with regulators in the United States, but there's still a long way to go. Liu Zhihua reports.

For Tarek Hassanein, a professor of medicine at the University of California, San Diego School of Medicine, it took a long time to learn and finally to pronounce "fuzhenghuayu (FZHY)". That's the Chinese name of a patented Chinese drug that treats liver fibrosis, the scarring process of the liver from injuries and diseases.

The drug is the third patented Chinese medicine that has successfully completed Phase Two clinical trials in the United States. Compound Danshen Dripping Pill achieved that in 2010 and Xuezhikang Capsules did so early this year. Hassanein is one of the prime researchers supervising the trials in the US that test FZHY's efficiency and safety while treating American patients with liver disease, mostly hepatitis C.

Starting in 2010 and conducted in nine clinics, the trial was completed in early November, with 250 participants and 89 valid subjects.

"The preliminary data shows a trend that FZHY can stabilize the liver fibrosis in HCV-infected patients, and the tests show that FZHY is an anti-fibrotic with a good safety profile and is well-tolerated in the US population," Hassanein says.

"The completion of the trial confirms the ability of conducting random controlled trials on a botanical drug using a placebo as a control in the US and other Western countries."

Ren Dequan, retired deputy director of the State Food and Drug Administration of China, says the milestone makes patented Chinese herbal medicine one step closer to reality in the US market and even the world market, because the US agency has one of the world's strictest medicine approval and regulation systems. For further information about Chinese medicine, please click to learn Eyesight-protecting herbs and foods.

Traditional Chinese medicine dates back more than 4,000 years, and differs from Western medical practice in that it believes the human body is an organic and systemic whole, and any illness is a reflection of the body's state of imbalance.

In clinical practice, TCM has proven to be good at treating chronic diseases, because those ailments are often caused by multiple biological abnormalities, resulting in complicated drug targets which modern Western medicine may not have a good effect on, according to Liu Ping, the inventor of FZHY.

He says TCM can be a good alternative because it focuses on the whole of a person's health.

While TCM techniques such as acupuncture and massage have gained popularity in the West, herbal medicines are still not well-received among Westerners.

Few Chinese patented drugs have been approved by Western health authorities to enter into the drug market. Most such drugs and herbals are on supermarket shelves only as supplements and healthcare products, says Zhang Boli, a member of the Chinese Academy of Engineering and president of Tianjin University of Traditional Chinese Medicine.

"FZHY's success can provide useful information for patented Chinese drug producers who want to get into the international drug market," Zhang says.

Liver fibrosis is common among long-term liver disease patients, and FZHY has been widely used in China since 2003 to improve the condition, while Western medicine has no good cure for it.

FZHY's Phase Two trials used liver biopsies on patients to collect data on its efficiency and safety in treating liver fibrosis, and that has proved to be a wise move, Zhang says.

"For patented Chinese medicines to go international, it is important to make good use of TCM's positive effects in clinical conditions where Western medicine may have no better control, such as chronic diseases," Zhang says.

However, although FZHY has completed the second-phase clinical trials required by the US regulators, there is still a long way to go before final approval for the mainstream drug market in the US.

The overall success rate for drugs moving beyond Phase One trials to final approval is about one in 10, according to a study conducted by the trade group Biotechnology Industry Organization in 2011. For further information about Chinese medicine, please click to learn Brain-tonifying Chinese herbs.
Abstracted from chinadaily.com.cn.