Skip to main content

Scientists taking Chinese medicine west

By Pamela Boykoff, CNN
updated 2:44 AM EDT, Thu September 4, 2014
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.

CNN's Vivian Kam contributed reporting.

ADVERTISEMENT
Part of complete coverage on
updated 8:39 PM EDT, Mon September 22, 2014
He's one of the fieriest political activists in Hong Kong — he's been called an "extremist" by China's state-run media — and he's not old enough to drive.
updated 5:29 AM EDT, Tue September 16, 2014
Christians in eastern China keep watch in Wenzhou, where authorities have demolished churches and removed crosses.
updated 1:38 AM EDT, Wed September 10, 2014
Home-grown hip-hop appeals to a younger generation but its popularity has not translated into record deals and profits for budding rap artists.
updated 1:45 AM EDT, Tue September 9, 2014
Reforms to the grueling gaokao - the competitive college entrance examination - don't make the grade, says educator Jiang Xueqin.
updated 8:18 AM EDT, Fri September 5, 2014
Beijing grapples with reports from Iraq that a Chinese national fighting for ISIS has been captured.
updated 10:00 PM EDT, Sun August 31, 2014
CNN's David McKenzie has tasted everything from worms to grasshoppers while on the road; China's cockroaches are his latest culinary adventure.
updated 8:57 PM EDT, Thu September 4, 2014
Beijing rules only candidates approved by a nominating committee can run for Hong Kong's chief executive.
updated 3:14 PM EDT, Fri August 29, 2014
China warns the United States to end its military surveillance flights near Chinese territory.
updated 11:12 PM EDT, Thu August 28, 2014
China has produced elite national athletes but some argue the emphasis on winning discourages children. CNN's Kristie Lu Stout reports
updated 1:13 AM EDT, Tue August 19, 2014
Chinese are turning to overseas personal shoppers to get their hands on luxury goods at lower prices.
updated 5:08 AM EDT, Fri August 15, 2014
Experts say rapidly rising numbers of Christians are making it harder for authorities to control the religion's spread.
updated 12:52 AM EDT, Mon August 11, 2014
"I'm proud of their moral standing," says Harvey Humphrey. His parents are accused of corporate crimes in China.
updated 3:42 PM EDT, Wed August 6, 2014
A TV confession detailing a life of illegal gambling and paid-for sex has capped the dramatic fall of one of China's most high-profile social media celebrities.
updated 12:10 AM EDT, Thu July 31, 2014
President Xi Jinping's campaign to punish corrupt Chinese officials has snared its biggest target -- where can the campaign go from here?
updated 3:12 AM EDT, Wed July 30, 2014
All you need to know about the tainted meat produce that affects fast food restaurants across China, Hong Kong, and Japan.
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 the Chinese president 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.
ADVERTISEMENT