Significant progress in the development of anticancer Chinese medicine in China Kanglaite injection into the US clinical trial

Significant progress in the development of anticancer Chinese medicine in China Kanglaite injection into the US clinical trial

July 06, 2015 Source: Xinhuanet

According to reports, Kanglaite Injection is a research team led by Li Dapeng, a member of the Chinese Academy of Engineering and a professor at Zhejiang University of Traditional Chinese Medicine. It uses the leading international technology such as supercritical carbon dioxide extraction to extract and isolate anti-cancer active ingredients from Chinese wolfberry. A safe, effective, fast-acting, and technologically advanced intravenous emulsion. The experimental research and clinical trials of medical research institutes in China, the United States, Russia and other countries have proved that it has significant therapeutic effects on advanced malignant tumors such as pancreatic cancer, lung cancer and liver cancer, and overcomes the drawbacks of chemotherapy drugs that damage normal human cells. It can effectively improve the immune function of cancer patients.

The research has been listed in the "Seventh Five-Year Plan", "Eighth Five-Year Plan", "Ninth Five-Year Plan" and "Tenth Five-Year Plan" major scientific and technological research projects by the State Administration of Traditional Chinese Medicine and the Ministry of Science and Technology, and the second and third phase clinical trials of Kanglaite Injection. The Research is listed as the National Eleventh Five-Year Major New Drug Creation Project and the China Internationalization Demonstration Project. At the same time, this key technology of the high-level Chinese medicine research with the distinctive characteristics of China's traditional and modern organic has won the highest honor such as the National Technology Invention Award and the National Science and Technology Progress Award.

In order to promote the cause of Chinese medicine and expand the influence of Chinese medicine in the international market, Academician Li Dapeng first filed an application for registration of a new Chinese medicine to the US FDA in 1999. At the same time, he was keenly aware that Chinese medicine must pay attention to intellectual property protection when going abroad. So he invested heavily in the invention and applied for invention patents in 11 countries and regions including the United States, Japan, the European Union, and Russia, and successively obtained Russia and other countries. The drug registration certificate issued was successfully listed for sale.

The US FDA has always been known for the difficulty of registering new drugs and high cost. However, once the US market is opened, it basically opens the door to the international market. In the past ten years since the registration of new drugs in the United States, the academician Li Dapeng has overcome the difficulties of lack of funds, difficult cases, difficult communication, and self-raised funds of tens of millions of dollars. He has successfully completed preclinical research on Kanglaite injection. Clinical trials (toxicity studies) and phase II clinical trials have confirmed Kanglaite's safety and effectiveness in different aspects. Especially in the second phase of clinical trials, the treatment effect that shocked American oncologists was even more apparent. Among the patients with advanced pancreatic cancer, the main evaluation indicators showed that the median survival time of the patients in the Kanglaite treatment group was 1.9 months higher than that of the conventional anti-cancer western medicine control group in the United States; the objective response rate was increased by 85.7%; one year survival The rate was 26.9% in the Kanglaite group and 9.1% in the control group. The median disease-free survival was 114 days in the Kanglaite group, which was significantly higher than the control group's 57.5 days. The American Science magazine praised Kanglaite as a representative result of patents after the invention of the Chinese herbal medicine ephedrine and artemisinin.

The success of the Phase II clinical trial made Kanglaite the first Chinese medicine injection product to enter Phase III clinical trials in the United States, and laid the foundation for a wider range of anticancer treatments. Academician Li Dapeng said that he is willing to carry out strategic cooperation with Chinese and foreign pharmaceutical companies on the results of this number of effective patents, complete the three-phase test as soon as possible, accelerate the process of Chinese medicines going global, and let Kanglaite injections benefit the majority of cancer patients at home and abroad.

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