Kanglaite, an anticancer traditional Chinese medicine injection, has been approved by FDA to enter the third phase of clinical practice

Zhejiang University of traditional Chinese medicine held a press conference in Beijing on the 27th, announcing that Kanglaite injection, an anti-cancer Chinese medicine with independent intellectual property rights, has been approved by the U.S FDA and has entered the third phase of clinical practice and has been widely used in cancer patients in the United States This also means that Kanglaite will become the first Chinese medicine injection product to enter the third phase of clinical practice in the United States, and lay a foundation for cancer treatment in a wider range Kanglaite injection is a scientific research team led by Li Dapeng, academician of Chinese Academy of engineering and professor of Zhejiang University of traditional Chinese medicine It is a safe, effective, quick acting and technologically advanced intravenous emulsion, which is extracted and separated from coix seed by supercritical CO2 extraction and other internationally leading technologies According to the experimental and clinical studies of medical research institutions in China, the United States, Russia and other countries, Kanglaite not only has a significant therapeutic effect on pancreatic cancer, lung cancer, liver cancer and other advanced malignant tumors, but also overcomes the disadvantages of chemotherapy drugs damaging normal cells of human body, and can effectively improve the immune function of cancer patients In the second phase of clinical trials, the main evaluation indexes showed that the median survival time of the patients in the Kanglaite treatment group was 1.9 months longer than that in the control group; the objective remission rate was 85.7%; the one-year survival rate in the Kanglaite group was 26.9%, and the control group was 9.1%; the median progression free survival time in the Kanglaite group was 114 days, significantly higher than the 57.5 days in the control group This 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 topics by the State Administration of traditional Chinese medicine and the Ministry of science and technology, and the "Kanglaite injection phase II and phase III clinical" as the "major new drug creation project" of the eleventh five year plan has also passed the acceptance (the research group led by Li Dapeng, academician of Chinese Academy of engineering and professor of Zhejiang University of traditional Chinese medicine, led the development of Kanglaite injection.) in fact, as early as 1997, Kanglaite injection has obtained the national new drug certificate, which has been widely praised by patients and medical students in many years of clinical application At the same time, this high-level Chinese medicine research, which has the distinct characteristics of the organic combination of Chinese tradition and modern, has also won the National Technology Invention Award and national science and Technology Progress Award and other highest honors In 1999, Academician Li Dapeng took the lead in applying to FDA for registration of new Chinese medicine At the same time, he realized that Chinese medicine must pay attention to the protection of intellectual property rights when going abroad, so he did not hesitate to invest a lot of money, and successively applied for invention patents in 11 countries and regions such as the United States, Japan, the European Union, Russia, etc., and successively obtained drug registration certificates issued by Russia and other countries, and successfully went on the market Li Junwei, vice president of Zhejiang University of traditional Chinese medicine, said at the conference that it is recognized at home and abroad that the FDA of the United States has always been famous for the difficulty and high cost of new drug registration However, once the U.S market is opened, the door to the international market is basically opened In more than ten years of new drug registration in the United States, Academician Li Dapeng's team has overcome many difficulties, such as lack of funds, difficult case selection and communication difficulties With self raised funds of tens of millions of dollars, it has successfully completed ind (preclinical study), phase I clinical trial (toxicity study) and phase II clinical trial of Kanglaite injection, which proves the safety and effectiveness of Kanglaite from different aspects "The success of small-scale phase II clinical trials has made Kanglaite the first Chinese medicine injection product to enter phase III clinical in the United States, and laid a foundation for cancer treatment in a wider range." Li said Academician Li Dapeng, the inventor of Kanglaite, said that he is willing to carry out strategic cooperation with large pharmaceutical companies at home and abroad on this achievement with multiple effective patents, complete the third phase test as soon as possible, accelerate the process of Chinese national treasure traditional Chinese medicine going to the world, and let Kanglaite Injection benefit tumor patients at home and abroad According to relevant media reports, Kanglaite injection has successfully completed preclinical research in the United States The first phase of clinical trial (toxicity investigation) and the second phase of clinical trial confirm the safety and effectiveness of Kanglaite from different aspects Especially in the phase II clinical trial, the main evaluation indexes of the patients with advanced pancreatic cancer showed that the median survival time of the patients in the Kanglaite treatment group was 1.9 months longer than that in the control group with conventional Western anti-cancer drugs in the United States; the objective remission rate was 85.7%; the one-year survival rate of the Kanglaite group was 26.9%, and the control group was 9.1%; the median progression free survival time of the Kanglaite group was 114 days, significantly higher than that in the control group 57.5 days in the control group It is reported that the third phase clinical trial of Kanglaite traditional Chinese medicine injection in the United States, in addition to the United States, will also be carried out in China and Eastern Europe at the same time It is estimated that 750 patients will be included in the clinical trial with Kanglaite, and the investment is expected to be no less than 50 million US dollars What is Kanglaite? Kanglaite has long been a well-known Chinese anti-cancer medicine in China Its injection is a key research topic of the Seventh Five Year Plan of the State Administration of traditional Chinese medicine In 1993, it passed the national appraisal Its functions include: reducing cancer cells, combining with radiotherapy and chemotherapy can reduce the side effects of chemotherapy, improve the body immunity, and significantly improve the quality of life and survival period of patients What is Kanglaite? It also starts from the 1970s, when Li Dapeng just graduated from Shanghai First Medical College His ambition is to challenge cancer with traditional Chinese medicine Li Dapeng takes "coix seed" as the research goal Coix seed is a traditional Chinese medicine which has been used for thousands of years in China It is called "the king of Gramineae in the world" Li Dapeng's research and development work in recent decades is summed up as "alternating cold and summer, day after day" Just like all the story versions that insist on winning, Li Dapeng and his team found and isolated a group of two-way anticancer compounds, Coix glyceride, which can not only effectively inhibit cancer cells, but also improve the immune function of the body and protect normal cells Kanglaite injection is a kind of emulsion which can be used for intravenous and arterial injection In short, the cancer patients who were going to receive chemotherapy can have similar or better curative effect after injecting the drug "Chemotherapy is very painful for patients, and normal cells will be killed if their hair is not polished, which will cause great harm to human body." Li Dapeng said that Kanglaite traditional Chinese medicine injection can improve the quality of life of patients a lot More than 2 million cancer patients in China have received Kanglaite's effective treatment "Next, I will focus on my family." Li Dapeng, 65, said in an exclusive interview with reporters the day before the conference, "the hardest work has been completed, and I will continue to study next, but the main thing will be left to the young people." In the conference room of Diaoyutai State Guesthouse in Beijing the day before the press conference (June 26), the staff have arranged the large screen, guest seat and autograph needed for the next day At 4:30 p.m., Li Dapeng came to the scene again, "show me the list of guests present." He told the staff around him that there were many names of academicians, university presidents, leaders of the national health and Family Planning Commission and the State Administration of traditional Chinese medicine He soon found out the mistakes of the names on the table according to the order, so he put them in the correct positions one by one, looked left and right, and adjusted them to a straight line as much as possible "I'll play the short film on the big screen again tomorrow." After that, he shouted to the backstage staff, and then the music rang On the big screen, he began to play a short commentary called "internationalization of traditional Chinese medicine is no longer a dream" Li Dapeng opened a chair in the audience and sat down, holding his chest in both hands, and watched the whole film At 9 p.m., Li Dapeng, who had been traveling all day, was finally free to accept an interview with Qian Bao's reporter In the hotel room where he lived, it was easy to see his pursuit for details: the sofa and desk were moved to a more wall, which made the room more spacious, so that the room could accommodate more people "I'll see tomorrow's speech later." He turned to his secretary and said, "we should do everything the same as research We must be cautious and not make any mistakes." Li Dapeng picked up the tea at hand, took a sip and said, "we are making medicine, facing the living people, what if we are not rigorous?" As the first academician in the field of traditional Chinese medicine and pharmacy, Li Dapeng has received enough praise in his personal honor and career However, in his opinion, the scientific research of traditional Chinese medicine is still on the way, "traditional Chinese medicine stresses the unity of man and nature, and has a dialectical understanding of diseases and different patients." The talkative Li Dapeng said that after the conference, his life focus will shift to the family, rather than focusing on work as before One hot noon in 1989, Li Dapeng, who was doing experiments in a narrow laboratory in Hangzhou, was burned by 10000 ml of chemical solvent which exploded suddenly 85% of the burned area caused serious burns to his mouth, nose and ears, and the functions of liver, kidney and heart were seriously damaged Several times of his life was on the verge of death 26 years later, from his appearance, it is not easy to see the injury of the accident in that year, but the experience of that ordeal makes him more willing to return to his family life after success "In fact, in the recent period, I have not been in the same working state as in the past, fishing and flower raising." Li Dapeng said that now the U.S FDA has approved Kanglaite's phase III test, the next work and effort will not be as hard as in the past, and he is more willing to let people take over these things, "of course, the research will not stop, but the family also needs to take care of more." The internationalization of traditional Chinese medicine is not only a dream of Li Dapeng alone In the eyes of Yu Wenming, deputy director of the State Administration of traditional Chinese medicine, this dream also has practical significance, "why should traditional Chinese medicine be internationalized? China's thousands of years of practice has proved the efficacy of traditional Chinese medicine Through the process of internationalization, it can introduce advanced technology from abroad and drive its own technology " [excerpted from zhongxin.com, xinhuanet.com and Qianjiang Evening News]