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The 2015 Nobel Prize in Physiology or Medicine, was bestowed upon Youyou Tu. Her discovery of the powerful malaria drug artemisinin, a novel therapy against malaria, has benefitted more than 240 million people in Sub-Sahara Africa and saved more than 1.5 million lives. One of the three winners of this year’s most prestigious prize in medicine, Tu is not only the first Chinese woman to win any Nobel Prize but also the first Chinese scientist to win a Nobel Prize in science for work done in China.
Her story is one of a legend
In 1969, 39-year-old Tu Youyou was summoned for Project 523, a military program created to find a cure for malaria. The project took on extra urgency after Vietnam's leaders, whose soldiers were succumbing to malaria during their war against the United States, requested assistance from China. While millions were dying from the disease, the problem got compounded as some types of malaria had started developing resistance to traditional drugs such as quinine and chloroquine.
Trained in both Western and traditional Chinese medicine (TCM), Tu decided to tap into the wisdom of ancient China. The quest for a treatment had the research team reading antique books, looking at folk prescriptions and consulting veteran TCM doctors.
It was not until more than 100 Chinese herbs had failed that sweet wormwood, which had generated inconsistent results in past, regained Tu's attention. The critical breakthrough was found in a book written in 340 BC by Ge Hong, titled A Handbook of Prescriptions for Emergencies.
The solution was to extract sweet wormwood (Artemisia Annua) by switching to lower temperatures, which in turn preserved the drug’s antimalarial properties and introduced the researchers to artemisinin.
While the temperature switch led to the isolation of artemisinin and animal trials were successful, such were the days of China’s Cultural Revolution, that human clinical trials could not be performed.
Tu volunteered herself as a test subject for the human trial that followed however the exposure to hazardous chemicals led to her having toxic hepatitis.
The story of artemisinin is one where Tu, now 84 years old, and her fellow researchers successfully married the knowledge of Chinese traditional medicine with the rigors of modern medicine.
An artemisinin-based drug combination is now the standard regimen for malaria, and the World Health Organization lists artemisinin and related products in its catalog of "Essential Medicines."
Get ready for more
After already introducing the world to ephedrine, a stimulant and decongestant derived from Mahuang, and artemisinin, more products are being taken from Traditional Chinese Medicine and subjected to the rigors of modern day science.
KangLaiTe isolated from coix seeds, a grass related to rice and maize, is in Phase III clinical studies to treat pancreatic cancer. KangLaiTe has been widely used by patients in China since it was certified in 1995 and has been listed by the Chinese government as a "State Basic Drug", "State Basic Medical Insurance Drug" and "State Key New Drug".
While KangLaiTe moved into Phase III trials in June this year, Dantonic®, used in China to treat and prevent chronic stable angina pectoris and other cardiovascular disease related conditions is targeting to complete its Phase III trials by next year.
Dantonic®, a botanical drug approved in 26 countries outside the United States, consists of borneol along with the extracts from a plant in the mint family, Danshen (Radix Salviae Miltiorrhizae) and another that is related to ginseng, San Qi (Radix Notoginseng).
The challenges of drug development still hold
However, not all contenders from Traditional Chinese Medicine have been successful.
HMPL-004, an extract from Andrographis for the treatment of ulcerative colitis was one of the key drivers for global giants, Nestle and Hutchinson Meditech, to combine forces and form a joint venture. Clinical work on HMPL-004 was “terminated in August 2014 following an interim analysis”.
The venture which aims to get a drug approved from China continues to soldier on. Fruquinitib (HMPL-013), their candidate for colorectal cancer, met the primary end point of its Phase II clinical trial in March this year.
Menerba a treatment derived from 22 herbs that are traditionally used in Chinese medicine, for the treatment of menopausal symptoms, started Phase III clinical trials in 2011. However, since then Bionovo, the company developing Menerba, has stopped reporting any progress.
Our View
Over the past years, most Big Pharma companies have announced plans to develop drugs from Traditional Chinese Medicines which still constitute a major portion of the drug reimbursements in China.
As TCM is “growing at a faster clip” outside China than within the country of its origin, China is also emerging as a strong innovator which leads the world in patent applications (more than 820,000 in 2013).
Backed by centuries of science, and scientists like Youyou Tu, China will certainly emerge as a center of drug innovation in the years to come.
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