TCM has a long way to go global
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Guizhou Tongjitang Pharmaceutical Co. Ltd. (TJT) began an ambitious campaign five years ago, evaluating one type of capsule containing traditional Chinese medicine 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 of traditional Chinese medicines (TCM) since, if the capsule was approved by the FDA. Drug makers in China would have a huge market overseas and the country would be happy to see medicines, which have 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 on Tuesday that the company had still not finished their preparations to 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 project on the production lines to realize that the quality of the products could be as stable as the level required by the FDA standards," Xu said.
"The U.S. criteria for a prescription drug seemed to be too harsh for traditional Chinese medicines. We are not ready yet," he said.
The TJT is promoting a medication that could treat osteoporosis, commonly called bone loss. The drug was made in accordance with a proven mixture from the Miao nationality that has been used for hundreds of years in China.
The TJT is one of the pioneers in the traditional Chinese medicine industry to promote Chinese patent drugs, which are made from Chinese medicinal plants, such as herbs, in foreign markets.
These companies are either in the midst of pre-clinical studies or conducting Phase I and Phase II FDA clinical trials for safety and efficacy verification. Most new drugs finishing Phase III clinical trials can be sold in the U.S. market under the FDA guidelines.
Most of these Chinese drug makers have encountered two major obstacles in the FDA's marathon-like three-phase clinical trials. One is that theories on composition of Chinese medications and how they work in the human bodies are difficult to explain. The other problem is the huge expense of conducting the trials.
Many traditional Chinese medicines are mixtures of a number of ingredients, which makes them much more difficult to explain than western drugs in a quantitative analysis.
The efficacy of the Chinese medicines depends on different combinations of those ingredients long-proven by countless human tests and inherited from ancient Chinese physicians. But no one can explain the reasons for mixing those combinations.
"It's hard to tell which kind of ingredients are actually taking effect. But to pass the FDA's trials, you can not be fuzzy about it," said Professor Di Liuqing with Nanjing University of Chinese Medicine.
"Funds for supporting the clinical trials in the U.S. are our heaviest burden," said Xiao Wei, board chairman of Kanion Pharmaceutical, a TCM manufacturer in China.
Kanion is promoting a product that eases discomfort for women who are menstruating, which is undergoing Phase II trials performed by some 200 volunteer patients. The company will spend about 300 million U.S. dollars if it successfully undergoes all clinical trials.
Instead of trying to have TCM products registered as medications, some TCM companies in China are seeking another path to promote their products overseas.
Beijing Tongrentang (TRT), a 340-year-old traditional Chinese medicine pharmaceutical company, has established at least 38 outlets in Australia, Britain, Japan, the Republic of Korea and some Southeast Asian countries.
The company sent more than 100 Chinese physicians, who are licensed by local authorities, to those TRT stores to allow customers to consult about treatments for diseases.
The TRT's strategy is to foster enthusiasm and trust about traditional Chinese medicines and therapies among foreign patients through the consultations so that foreigners learn to gradually accept Chinese medicines, said Tian Ruihua, the TRT's chief scientist.
