Chinese traditional medicine makes headway to world stage

The traditional medicine practiced in China for millennia finally made a strong headway to the world stage after many earlier such attempts failed.

A China-made pill to treat cardiovascular conditions had been tested safe and effective by the U.S. Food and Drug Administration (FDA) and hopefully would be marketed in the United States as early as 2013, its Tianjin-based pharmaceutical manufacturer, Tasly, said Saturday.

The drug, called Compound Danshen Dripping Pill, passed the FDA's Phase II clinical trials in July. Once Phase III is completed, Tasly can ask for the FDA approval to market the drug in the United States.

Previously, the drug has been approved by drug watchdogs in Canada, Russia, South Korea, Vietnam, Singapore and some African countries.

The breakthrough did not come easily. Efforts for promoting the Chinese traditional medicine to the world market have been going on for years, but little progress has been made in the U.S. and European markets.

There are many barriers on the way to the Western drug markets, and one of them is the different curative mechanisms between Western medicine and traditional Chinese medicine.

As a result, it's difficult to explain how traditional Chinese medicine works according to the criteria of the Western pharmacy.

Secondly, in the West, the clinical trials that every new drug should go through before getting certificated is a long and rigorous process. Many Chinese herbal medicine producers were thus scared away.

In the United States for example, new drugs need to pass three phases of clinical trials before receiving FDA approval to enter the market.

Usually, Phase I tests a new drug or treatment in a small group of people. It lasts for some 12 months, focusing on the safety of the new drug when used in people.

Phase II trials gauge the effectiveness of the drug and its side effects and risks. It often needs 100 or more patients to join the tests and may take two to three years.

Phase III trials are even more extensive. They need several hundred to several thousand patients chosen randomly and take two to four years on average. These tests compare the new drug to the standard or best known drug when treating the same kind of illness.

Statistics show that only one in 15 candidate drugs pass all three phases. Most failed to go beyond the second phase.

The low approval rate plus high costs and long process for the trials kept many Chinese traditional drug makers, including renowned ones, out of the Western market.

Tasly, lauded by some as China's Pfizer, has paid a high toll for its success.

Once Compound Danshen Dripping Pill passes Phase III trials, it will become the first Chinese traditional herbal drug to win FDA approval.

The breakthrough that Tasly has achieved so far shows that Chinese traditional medicine can integrate into the international standard through innovation. Capable Chinese pharmaceutical companies should be brave enough to go to the international market and compete with others at the high end.