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.
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?
"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.
“眼下，产品越是简单就越好，”Chi-Med的CEO Christian Hogg如此说道。“从FDA的立场来看，越是和传统的药物相似就越好。”这也就是该公司最先开始研发一种叫做HMPL-004的药物的原因了，这种药物可以用来治疗炎症性肠病，包括溃疡性结肠炎和节段性回肠炎。
The testing was made possible by a change in the FDApolicies and procedures in 2004 regarding botanical drug products.
在FDA于2004对有关植物药产品的政策以及程序做了修改后，这款药物产品的测试才成为可能。
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. Fulzaq, 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.
目前，有2800名患者接受了第三阶段的临床测试，结果将决定这种HMPL-004药物是否安全有效。
If FDA agrees with the results, the drug will then enter the $7 billion global market to treat IBD.
如果FDA对结果没有意见，这种药物将进入70亿美元的全球市场来治疗炎症性肠病。
Chi-Med is not alone in its efforts to take Chinese botanical drugs beyond China.
当然，并不是仅仅只有Chi-Med致力于将中国植物药推向世界。
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.
SamFontana • 4 hours ago
Here come the bear bile and tiger bone along with all the animal parts that are going extinct.
中药里含有熊胆，虎骨以及其它一切正在灭绝的动物的身体部位。
GaiusCaesar • 5 hours ago
Chinese medicine actually tries to cure illnesses , not only to treat them. My wife will be happy, she rails against our medicine here.
不仅仅只是治疗，中药还致力于治愈疾病。我的妻子会很高兴的，她对我们这儿的药物不满意。
SamFontana • 4 hours ago
None of their stuff works, it is all based on superstition and myth.
这些中药没有一个是有效的，都是以迷信和神话为基础的。
jolly回复 SamFontana • 24 minutes ago
Like all religions which by the way are all from the East.
就像所有的宗教，哦，对了，所有的宗教都来自东方。
Baojiu回复SamFontana • an hour ago
Actually, bear bile, like you mentioned above, contains a biliary acid called ursodeoxycholic acid, a well known cholerhectic drug now produced synthetically to treat cholangitis or prevent gall stones. Acupuncture is a well-accepted treatment modality for neurological pain available in many modern western hospitals.
The total concept of wellness and managing health through nutrition are very valid concepts in healthcare that are undervalued in the west because of big pharma's profit-driven bottom lines.
James Wangsness • 2 hours ago
When I saw that Nestle, the multinational business conglomerate was involved with this project I became suspicious. They will simply turn this concept into a money making commercialized scheme much like US pharmaceutical firms who are profit driven rather than patient centered.
J Burke • 3 hours ago
No thanks. Can't be sure there isn't an endangered species in the mix.
不用了，谢谢。不能肯定是否有濒危物种被混在里面。
Anti-AntiUSPropaganda • 3 hours ago
I guess they forgot to run an article when Western medicine went East.
All science based medicine is Western, whether they admit it or not.
DanRyanExpressMan 回复Anti-AntiUSPropaganda • 16 minutes ago
I guess most readers here still remember Ravi Anti-Anti's job is a salesman of Indian snake oil.
Indian snake oil. It will cure cancer, AIDS and all kinds of diseases, except xenophobia, mental bias and simpleton mind, all carried by Ravi Anti-Anti.
Kunal Shah • 4 hours ago
The Chinese medicines shall destroy the corrupt western pharmaceutical industry that seeks to suppress symptoms and not cure the diseases. This shall then force the west to change their industry in order to survive.
CactusThorn • an hour ago
The west would be crazy not to study Chinese medicine. It can't all be hocus POTUS or the Chinese would have abandoned it long ago.
西方不学习中医那真是疯了，不可能所有的中药都是骗人的，否则否则中国人早就抛弃中医了。
Michael回复 CactusThorn • an hour ago
It wouldn't be the first time human beings believed hocus pocus for thousands of years, the most famous hocus pocus being religion.
The belief in the efficacy of Chinese medicine, despite a completely inconsistent record of effectiveness, can be attributed to confirmation bias.
