Skip to main content

Scientists taking Chinese medicine west

By Pamela Boykoff, CNN
updated 1:24 PM EDT, Wed June 12, 2013
STORY HIGHLIGHTS
  • Chi-Med and Nestle working to get FDA approval for some Chinese medicine
  • Phase III trials have started on HMPL-004 -- used to treat stomach problems
  • It's final round of trials before FDA approval to enter the $7B IBD market

Hong Kong (CNN) -- At Chi-Med's labs in Shanghai, a group of 70 chemists has been working for a decade to try and crack the mysteries of Chinese medicine.

The company's scientists are attempting to break 1,300 medicinal herbs into their component parts and then test them for global use against diseases.

It's an ambitious effort and one that looks close to paying off. Chi-Med, in partnership with Nestle, has started the first worldwide phase III clinical testing trials -- the final step before approval for sale -- for a botanical drug based on Chinese Traditional Medicine.

If Chi-Med and Nestle succeed in winning U.S. Food and Drug Administration (FDA) approval, the companies will be at the forefront of efforts to export Chinese medicine beyond its loyal following at home. They'll also have tackled the central problem in taking Chinese medicine global: how do you get a centuries-old remedy through the rigors of modern government regulation?

Build it, and will they come in China?
What is the 'Chinese Dream?'
China's bling dynasty
Bosideng in the UK

"The simpler the product, the better at this stage," says Chi-Med CEO Christian Hogg. "The more similar it is to conventional drugs, the better from the FDA standpoint." That's why the company has started with a drug called HMPL-004, which treats inflammatory bowel disease (IBD) including ulcerative colitis and Crohn's disease.

The testing was made possible by a change in the FDA policies and procedures in 2004 regarding botanical drug products.

The new guidelines removed some of the obstacles involved in getting an investigational new drug application (IND), the first step in getting a drug developed and marketed in the U.S.

Since the guidelines were introduced, the FDA has only approved two botanical drugs, according to the U.S. Department of Health & Human Services. Fulyzaq, an antidiarrheal drug used for HIV/AIDS patients and derived from the red sap of the Croton lechleri plant, was approved in December 2012. Veregen, a treatment for warts based on green tea extract, was given the green light in 2006.

By Chinese medicine standards, HMPL-004 is a simple drug. It's a single extract from a single herb, called andrographis, which has a long history of use in Asia for stomach problems.

Contrast that with She Xiang Bao Xin Wan, one of Chi-Med's primary products in China.

It's a prescription cardiovascular drug with over 100 different chemical components, which Hogg explains makes it nearly impossible to get through the current U.S. approval system. "If you are working with the FDA to register that, you are going to have to explain to them exactly where each of those compounds comes from and you are going to have to guarantee every step that exactly the same amount of the compound is in that product," he says.

There are currently 2,800 patients in the phase III clinical trials to determine if HMPL-004 is both safe and effective.

The more similar it is to conventional drugs, the better from the FDA standpoint.
Christian Hogg, Chi-Med

If FDA agrees with the results, the drug will then enter the $7 billion global market to treat IBD.

Chi-Med is not alone in its efforts to take Chinese botanical drugs beyond China.

Dr. Yibin Feng at Hong Kong University's School of Chinese Medicine is studying the effectiveness of Chinese medicine treatments for cancer and liver disease. He says the lack of advanced science and technology has meant in the past that traditional Chinese medical doctors did not understand how the treatments worked. "We know this works for some disease, but I don't know what the scientific basis is," he says. "Why does it work for this disease?"

Dr. Feng believes all of that is changing now. Both he and Hogg think the slowing pace of conventional drug development is driving more people to look to Chinese medicine.

"Now new drug discovery from natural products and other material is more difficult that many years ago, people notice the wisdom in Chinese medicine," says Dr. Feng. He's particularly hopeful people outside China will begin to see the value in China's more complicated, multi-ingredient treatments. In fact, he sees these multi-faceted remedies as one of the major assets of Chinese medicine.

Dr. Hogg believes gradually the foreign regulators will become more open to the range of Chinese drugs. "It is in the best interest for the public health to be bringing these therapies to the market," he says.

ADVERTISEMENT
Part of complete coverage on
updated 8:37 AM EDT, Wed April 16, 2014
Mentions of the 1989 Tiananmen Square student protests or political reform are still censored in China.
updated 2:01 PM EDT, Sun April 13, 2014
CNN's Brian Stelter talks with CCTV correspondent Jim Spellman on how the Chinese media has covered MH370's mystery.
China's economy has bested many others in just the past 10 years.
updated 2:02 AM EDT, Fri April 11, 2014
In China, users of the "Life Black Box" website can set up final farewells to their friends in case they suddenly die.
updated 1:32 AM EDT, Fri April 11, 2014
A recent university study claims Chinese micro-blogging activity might not be as vibrant as expected.
updated 6:14 AM EDT, Thu April 10, 2014
Chinese art has been fetching some serious cash -- here's how we can elbow into the market
updated 10:51 PM EDT, Wed April 9, 2014
A Shanghainese collector paid $36 million for this tiny cup decorated with chickens.
updated 2:57 AM EDT, Tue April 8, 2014
Ben Richardson on corruption in China: a veil of secrecy shrouds the links between power and wealth.
China's economy is slowing and growth in 2014 could fall short of the government's official target, according to a CNNMoney survey of economists.
updated 8:38 AM EDT, Tue April 8, 2014
U.S. Defense Secretary Chuck Hagel is the first foreigner to visit the Chinese aircraft carrier Liaoning.
updated 9:26 PM EDT, Sun April 6, 2014
If the disappearance of Malaysia Airlines Flight MH370 caused a rift in China-Malaysia relations, the two countries appear to have put it behind them.
updated 1:17 AM EDT, Fri April 4, 2014
Martin Jacques argues that in the twenty-first century, China will challenge our perception of what it is to be modern.
A new survey of university students in China shows where they most want to work. What are the dream employers for Chinese students?
updated 9:24 AM EDT, Wed April 2, 2014
What are President Xi Jinping's greatest goals as he visits the EU headquarters in Brussels?
Last year, thousands of Chinese tourists flocked to Yellowstone National Park to view the mountains, the buffalo and Old Faithful.
updated 8:38 AM EDT, Mon March 31, 2014
A senior Bloomberg News journalist quit his role earlier this month, saying the "mishandling" by his bosses of a story critical of China was behind his departure.
updated 7:55 AM EDT, Thu March 27, 2014
"The aim is to let [families of MH370 passengers] express anger while keeping them restrained," says a Chinese official.
updated 9:58 AM EDT, Thu March 27, 2014
U.S. President Barack Obama's secret weapon in China? Michelle.
updated 10:53 PM EDT, Wed March 26, 2014
Private schools that employ humanistic pedagogy for young children are becoming popular in China. A look at the factors behind the boom and potential pitfalls.
ADVERTISEMENT