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
See CNN's complete coverage on China.
updated 10:30 PM EDT, Thu July 17, 2014
Some savvy individuals in China are claiming naming rights to valuable foreign brands. Here's how companies can combat them.
updated 5:11 AM EDT, Wed July 16, 2014
Is Xi Jinping a true reformist or merely a "dictator" in disguise? CNN's Beijing bureau chief Jaime FlorCruz dissects the leader's policies
updated 11:44 PM EDT, Mon July 7, 2014
With a population of 1.3 billion, you'd think that there would be 11 people in China who are good enough to put up a fight on the football pitch.
updated 2:31 AM EDT, Fri July 4, 2014
26-year-old Ji Cheng is the first rider from China to compete for competitive cycling's highest honor.
updated 7:24 AM EDT, Mon July 7, 2014
China's richest man, Wang Jianlin, may not yet be a household name outside of China, but that could be about to change.
updated 12:14 AM EDT, Fri July 4, 2014
Hong Kong's narrow streets were once a dazzling gallery of neon, where banks and even bordellos plied their trade under sizzling tubular signs.
updated 7:57 PM EDT, Thu July 3, 2014
When President Xi Jinping arrives in Seoul this week, the Chinese leader will have passed over North Korea in favor of its arch rival.
updated 7:59 AM EDT, Thu July 3, 2014
Three more officials have been given the chop as part of China's anti-corruption drive, including former aides to the retired security chief.
updated 9:05 AM EDT, Tue July 1, 2014
As thousands of Hong Kongers prepare for an annual protest, voices in China's press warn pro-democracy activism is a bad idea.
updated 12:37 AM EDT, Mon June 30, 2014
Hong Kongers are demanding the right to directly elect their next leader, setting up a face-off with Beijing.
updated 2:56 AM EDT, Tue July 1, 2014
The push for democratic reform in Hong Kong is testing China's "one country, two systems" model.
updated 7:56 AM EDT, Mon June 30, 2014
Along a winding Chinese mountain road dotted with inns and restaurants is Jinan Orphanage, a place of refuge and site for troubled parents to dump unwanted children.
updated 4:36 AM EDT, Thu June 26, 2014
CNN's Kristie Lu Stout invites Isaac Mao, Han Dongfang, and James Miles to discuss the rise of civil society in China and social media's crucial role.
updated 11:34 PM EDT, Wed June 25, 2014
Chen Guangbiao wants rich people to give more to charity and he'll do anything to get their attention, including buying lunch for poor New Yorkers.
updated 7:44 AM EDT, Thu June 26, 2014
Architects are planning to build the future world's tallest towers in China. They're going to come in pretty colors.
updated 7:47 AM EDT, Mon June 23, 2014
Anna Coren visits Yulin's annual dog meat festival. Dogs are part of the daily diet here, with an estimated 10,000 dogs killed for the festival alone.
updated 2:38 AM EDT, Thu June 19, 2014
People know little about sex, but are having plenty of it. We take a look at the ramifications of a lack of sex education in China.
updated 4:12 AM EDT, Fri June 13, 2014
Hong Kongers have reacted angrily to a Chinese government white paper affirming Beijing's control over the territory.
The emphasis on national glory -- rather than purely personal achievement -- is key.
updated 12:14 PM EDT, Mon June 16, 2014
A replica of the Effel Tower in Tianducheng, a luxury real estate development located in Hangzhou, east China's Zhejiang province.
What's the Eiffel Tower doing in China? Replica towns of the world's most famous monuments spring up all over China.
updated 8:13 PM EDT, Tue June 10, 2014
Rapid development hasn't just boosted the economy -- it has opened up vast swathes of the country, says a man who has spent much of his life exploring it.
updated 2:54 AM EDT, Tue June 10, 2014
The World Cup is apparently making a lot of people "ill" in China.
ADVERTISEMENT