Yang Dajun: let the clinical trial filing system take the lead in the field of tumor drugs

When he was a university student, he became a celebrity of his time because of his participation in the well-known family doctor magazine Later, his further study in the United States gradually faded out of everyone's sight A few years later, he returned to China and founded ascentage Pharma) made some breakthroughs in the research of new drugs He once again entered the spotlight of the media, but most people are very difficult to relate his two experiences together Only when they occasionally heard "pay attention to the social significance of new drug research and actively guide the public opinion", would they suddenly remember that he once ran a magazine People don't often mention him, and he has a lot to do with being easygoing and low-key In fact, his company has two products in clinical trials, namely at-101 and apg-1387 Their main indications are three negative breast cancer and drug-resistant brain glioma At present, there are no effective treatment drugs for these two diseases in the world Therefore, he hopes that We can make a breakthrough in this area At the end of May, after returning home from "flying" in the United States, he participated in various academic conferences and spent a lot of time focusing on the development trend of domestic drug R & D policies and regulations and the change of domestic innovation environment Because he studies cancer drugs, he pays special attention to the treatment of cancer patients He said that what he wants to do most is to let the Chinese people get the new drugs they can afford in the shortest time to treat diseases, especially the life-saving drugs for cancer Therefore, a discussion on precise tumor treatment was organized at the first pharmaceutical frontier Summit Forum held by pharmaceutical progress in Nanjing "The current situation of cancer treatment in China is not satisfactory," he said The mortality rate of cancer patients is significantly higher than that in Europe and America There are 3 million cancer patients and 2 million deaths in China every year At present, the cure rate of cancer in China is only half of that in the United States According to the statistics of China Cancer Association, the average cure rate of cancer in the United States can reach 60% - 80%, but only about 40% in China " Yang Dajun thinks that this has a lot to do with the slow speed of Chinese new drugs entering clinical trials The time for the same drug to be listed in China on average is 3-4 years later than that on the international market If the new drug can be put into clinical practice earlier, it is estimated that one million cancer deaths can be reduced in one year The economic and social losses caused by the death of one million people should be much higher than that of Ebola epidemic Loss caused From the words he spoke, he heard some pity and helplessness He said: "now, basically, each of us has relatives, colleagues or friends who have cancer The sufferings of the patients themselves and their families are huge." So he has a strong desire to promote the progress of clinical trials in China, so that patients can get a good drug early When I saw him in the conference hall, he walked up to me with great strides After a simple greeting, he began to speak his mind Reporter: Shi yingzi asked: what do you want to call for when you host this forum today? Yang Dajun: I hope that the state can first open a mouth to the people's life-saving drugs in the approval of drug clinical trials, and take the lead in adopting the clinical trial filing system At present, there is no big problem in the technical, ethical and policy impact Countries can also, like free trade zones, conduct pilot projects in the Yangtze River Delta or the Pearl River Delta first, and then promote them in a large scale when the time is more mature Q: will patients have concerns about the state's accelerated approval of clinical trials? Yang Dajun: for patients with cancer and other fatal diseases, the possibility of patients' benefit is far greater than the risk when they participate in clinical trials of new drugs All the advanced tumor patients in phase I clinical trial failed in the existing treatment For patients with advanced cancer, his biggest "enemy" is cancer cells, the vast majority of patients died before the new drugs could play a role At this time, if the new drug can save a patient, it will benefit the patient and his family 100% The patients in phase II or phase III, especially the patients in the combined drug trial, the control group is the conventional treatment method, and both groups have been treated From an economic point of view, patients will also benefit In China, the cost of targeted cancer drugs is very expensive Only 10% of lung cancer patients receive TKI drugs, while those who participate in the trial can get free drugs, which significantly reduces the economic burden Q: many innovative companies, like you, are calling for accelerated approval of clinical trials Why? Yang Dajun: the purpose of innovative drug research and development is to solve the clinical problem that there is no drug to treat or conventional drug treatment fails Patients are the first to benefit from the success of new drug development Patients and their families are the biggest victims of any delay in the launch of new drugs Innovative drug R & D companies invest a lot of research costs for drug development before the new drug goes on the market We see that Geely's hepatitis C drugs sold more than $10 billion a year after they went on the market, and the company's losses will be obvious if they are approved one year later The sales volume of domestic beta pharmaceutical's exetinib in one year after listing is expected to be 700 million yuan, with a peak of 1 billion yuan Therefore, the late approval of domestic drugs for one year has caused great losses to enterprises Q: some people think that local innovation is a contradiction between China and new drugs abroad What do you think of this? Yang Dajun: let foreign drugs enter China as soon as possible, and Chinese people can also get the best disease treatment drugs as soon as possible In addition, the new drug innovation in China is not completely negative, but will save the cost of research and development, reduce the difficulty of marketing From the case of Beida, because the first in class has been used in China for a certain period of time, and its efficacy has been recognized, the clinical research time of exetane has been significantly shortened, and the recruitment of subjects has not consumed too much energy The largest investment in new drug research and development of Beida is to spend tens of millions of dollars to purchase the original research drug for control test At the same time, due to the foreshadowing of the pioneering drugs to the domestic market, the best in class can obtain a good market share as long as it is 20% cheaper than the pioneering drugs The entry of foreign pharmaceutical enterprises into China has brought advanced technology and management experience, and promoted healthy competition in the market Therefore, I think it is not only for foreign drugs to enter China faster, but also for foreign cro companies to develop the Chinese market Q: what can we do now to speed up the clinical trials and approval of drugs on the market? Yang Dajun: in addition to the need for enterprises to "join hands" to promote the government to revise laws and regulations as soon as possible, the patient group should also act to influence the government's decision-making More than 20 years ago, when AIDS was found to be spreading rapidly in the United States, AIDS patients in the United States urged Congress to speed up the development and approval of anti AIDS drugs NIH in the United States has increased a lot of funds for the research and development of anti AIDS drugs, and FDA has opened a green channel for the approval of anti AIDS drugs At present, China lacks the participation of social forces in the research and approval of new drugs When FDA approves a new drug to be put on the market, there will be an open review meeting, in which a spokesperson usually speaks of the beneficiaries who participate in the clinical trial In the future, the voice of patients should be heard in the clinical trial, approval or ethical review of drugs in China Q: are the policy conditions for early trials in China not mature enough? The drugs developed by your company are also conducting clinical trials in many countries In your opinion, does China have any advantages over developed countries in phase I clinical trials? Yang Dajun: at present, the better choice for phase I clinical trials is in the United States, Australia and Taiwan There is still a certain gap in phase I clinical research in China, but there is a certain advantage in phase II and phase III clinical research in China, mainly because there is a large number of patients in China, and patients have received a lot of treatment before, so the final results of clinical trials will be better At present, the phase II clinical research and development of at-101 is carried out in China and the United States at the same time, and the phase I clinical research and development of apg-1387 is carried out in China and Australia at the same time Towards the end of the interview, Yang Dajun recommended to me the article of "public participation in clinical trials is not a mouse" He said that this article let domestic patients know that participating in clinical trials is not dangerous, and many trials can significantly benefit patients "The news broadcast reported that when Lu Xianping's xidaban, two patients appeared in the camera, one old and one young, both of whom were reborn after receiving the experimental drug, which was a great joy." Yang Dajun said After that, he left the conference hall in a hurry, and continued to discuss this topic with the people he met from time to time on the way I also want to hear what he was talking about Suddenly, the president of a company grabbed me He said that the clinical trial filing system was like Deng Xiaoping's southern tour of Shenzhen to set up a special economic zone We must find a breakthrough to try first, and we can't delay the event because of various concerns.