Pharmacy News EU

BEIJING, Jul 27, 2010 (Xinhua via COMTEX) Guizhou Tongjitang PharmaceuticalCo. Ltd. (TJT) began an ambitious campaign five years ago,evaluating one type of capsule containing traditional Chinesemedicine as they sought new drug approval by the United States’Food and Drug Administration (FDA).
People were expecting to see a dawning of wider acceptance oftraditional Chinese medicines (TCM) since, if the capsule wasapproved by the FDA. Drug makers in China would have a huge marketoverseas and the country would be happy to see medicines, whichhave been taken by countless Chinese for thousands of years,become a new brand promoting Chinese culture.
Things, however, have not been that simple.
Xu Qian, deputy general manager of the TJT, told Xinhua onTuesday that the company had still not finished their preparationsto officially submit its product for clinical trials to the FDA,known for its strictness in approving new drugs.
"We are undertaking a large-scale technical upgrading projecton the production lines to realize that the quality of theproducts could be as stable as the level required by the FDAstandards," Xu said.
"The U.S. criteria for a prescription drug seemed to be tooharsh for traditional Chinese medicines. We are not ready yet," hesaid.
The TJT is promoting a medication that could treatosteoporosis, commonly called bone loss. The drug was made inaccordance with a proven mixture from the Miao nationality thathas been used for hundreds of years in China.
The TJT is one of the pioneers in the traditional Chinesemedicine industry to promote Chinese patent drugs, which are madefrom Chinese medicinal plants, such as herbs, in foreign markets.
These companies are either in the midst of pre-clinical studiesor conducting Phase I and Phase II FDA clinical trials for safetyand efficacy verification. Most new drugs finishing Phase IIIclinical trials can be sold in the U.S. market under the FDAguidelines.
Most of these Chinese drug makers have encountered two majorobstacles in the FDA’s marathon-like three-phase clinical trials.One is that theories on composition of Chinese medications and howthey work in the human bodies are difficult to explain. The otherproblem is the huge expense of conducting the trials.
Many traditional Chinese medicines are mixtures of a number ofingredients, which makes them much more difficult to explain thanwestern drugs in a quantitative analysis.
The efficacy of the Chinese medicines depends on differentcombinations of those ingredients long-proven by countless humantests and inherited from ancient Chinese physicians. But no onecan explain the reasons for mixing those combinations.
"It’s hard to tell which kind of ingredients are actuallytaking effect. But to pass the FDA’s trials, you can not be fuzzyabout it," said Professor Di Liuqing with Nanjing University ofChinese Medicine.
"Funds for supporting the clinical trials in the U.S. are ourheaviest burden," said Xiao Wei, board chairman of KanionPharmaceutical, a TCM manufacturer in China.
Kanion is promoting a product that eases discomfort for womenwho are menstruating, which is undergoing Phase II trialsperformed by some 200 volunteer patients. The company will spendabout 300 million U.S. dollars if it successfully undergoes allclinical trials.
Instead of trying to have TCM products registered asmedications, some TCM companies in China are seeking another pathto promote their products overseas.
Beijing Tongrentang (TRT), a 340-year-old traditional Chinesemedicine pharmaceutical company, has established at least 38outlets in Australia, Britain, Japan, the Republic of Korea andsome Southeast Asian countries.
The company sent more than 100 Chinese physicians, who arelicensed by local authorities, to those TRT stores to allowcustomers to consult about treatments for diseases.
The TRT’s strategy is to foster enthusiasm and trust abouttraditional Chinese medicines and therapies among foreign patientsthrough the consultations so that foreigners learn to graduallyaccept Chinese medicines, said Tian Ruihua, the TRT’s chiefscientist.
"We did not push our traditional Chinese medicines into theFDA’s clinical trials early since westerners would not totallytrust our medicines and treatment if they do not fully understandthe Oriental culture," Tian told Xinhua.
"Production sales in our overseas stores are conducted inabsolute abidance with local regulations and laws. We sell them ashealth foods, dietary supplements and other categories as requiredby local laws," Tian said.
Prof. Di said another big challenge for traditional Chinesemedicines is the consistency of the quality of the medicine’singredients.
Unlike western medicines which are usually made of chemicalcompounds targeting specific diseases, traditional Chinesemedicines rely on materials, mostly medicinal plants, whosequality differs among different batches and production origins.
"It’s even more worrying now because of pollution, climatechange, residue of pesticides and heavy metal on herbs." Di said.
Nevertheless, Di believes the prospect for traditional Chinesemedicines to go global is still quite promising.
"Western medicines have their own defects, where Chinesemedicines could make up for. For instance, in treating chronicdiseases Chinese medicines could be used as supplementary to allaythe toxicity and side-effects brought by western medications.
"I am confident that traditional Chinese medicines will beembraced by the world one day. It just takes time for people fromother cultures to understand it and build faith in it," said Di.
The professor suggested that China should learn from itsneighbors, Japan and the ROK, to standardize the farming of herbs.
For instance, the ginseng grown in northeast China is of superbquality, but its sales in the global market is far behind Koreanginseng, because the Republic of Korea has excelled over China instandardized farming, Di said.
(c) 2010 XINHUA NEWS AGENCY