Pain points in innovative drug research and development of domestic pharmaceutical enterprises

"It's a pleasure that the good research results of the original drugs in our country are constantly recognized and published At the same time, we should feel that there is still room for efforts between these pharmacology and clinical needs We should continue to make more efforts to develop more and better drugs to meet the clinical needs " Shi Yuankai, deputy director of the National Cancer Center and vice president of Cancer Hospital of China Medical Science Park, said at the 10th China Pharmaceutical entrepreneur scientist investor conference recently The reporter of "daily economic news" noted that at this conference, many entrepreneurs and scholars deeply analyzed the current pain points in the development of innovative drugs in Chinese enterprises, such as the lack of talents, the need to improve the medical payment system, clinical trials, etc At the scene, some entrepreneurs called for national health insurance and third-party insurance to enter the innovative drug market The lack of talents is still a pain point in research and development The research and development of an innovative drug is often divided into several stages: the establishment of research and development targets, preclinical research, clinical trials, new drug application, marketing and testing, which is a veritable system engineering Liu Dianbo, chairman of the board of directors of green leaf life sciences group, stressed the internationalization of innovation of local enterprises He believed that "from talents to systems, from the selection of targets to the whole process of R & D, to the final approval of FDA - the whole process must have such patience and endurance, and also must be able to pay this price, and determined to attract international talents." At the conference, Liu Dianbo was not alone in mentioning the importance of talent construction Hu Zhengguo, the CEO of Wuxi apptec, also mentioned the pain point of talents: China is short of talents in the research and development of new drugs - both in the research and development stage and in the clinical research stage, "and the talents in China are hanging upside down." Hengrui pharmaceutical attaches great importance to the research and development of innovative drugs in domestic pharmaceutical enterprises, and in recent years, it has been increasing its internationalization efforts Sun piaoyang, chairman of the company, summed up many years of experience and thought that from the perspective of the whole clinical trial, the number of professional doctors in China is less than that in foreign countries, and there is a big gap between the whole experiment and management and the international advanced level The first is to meet the clinical needs of patients However, the whole process of a new drug from project initiation and development to market is 10 years or even longer Enterprises often need to invest a lot of money, which makes cost recovery a big problem for pharmaceutical enterprises According to Liu Dianbo, Chinese enterprises should be in line with the international standards in developing innovative drugs After all, the proportion of new drugs in the Chinese market is very low, so pharmaceutical enterprises should aim at the markets of developed countries "Our new drugs should create value and return In terms of market selection, we should firmly do the U.S market, the European Union market and the Japanese market to drive the Chinese market." Liu Dianbo said When the topic turns back to the domestic market, it becomes a hot topic for the participants to discuss whether innovative drugs can enter the medical insurance Hu Zhengguo, taking the listing of new drugs in the United States as an example, said: "after the listing of a new drug in the United States, the sales (just) came the next day, and the insurance has been discussed" While it is a long process for China's new drugs to enter the medical insurance, but in the future for the whole industry, the valuation of China's market is far greater than that of the United States, so "we hope that the national medical insurance and the third-party insurance will enter the market." It has been a long time in the society to discuss whether to support innovative drugs into medical insurance After all, the medical insurance fund itself is limited, so there are different opinions on "basic insurance" or "innovation introduction" Luo Yongqing, global vice president of Gilead science and general manager of China, said on this issue that China's medical insurance system has developed for 20 years since it was established in 1998 "At that time, it was required that the clinical necessary curative effect be exact and the price be cheap Recently, the national basic drug review has just been carried out Now (what is required) is that the clinical curative effect be significantly improved and the price be reasonable Innovative drugs should also be in this range Internal " Luo Yongqing said that China needs an objective and fair drug value system to judge whether a drug should be supported by the national health insurance Chen Qiulin, director of the Social Security Research Office of the Institute of population and labor economics of the Chinese Academy of Social Sciences, also said in an interview with the daily economic news that with the increase of the scale of medical insurance funds and the people's medical needs, higher requirements have been put forward for medical insurance management, and the medical and health technology and economic evaluation standards should be established as soon as possible In June 2017, the former State Food and Drug Administration (CFDA) officially became a member of ICH (International Coordination Committee for technical requirements of human drug registration), and China's drug regulatory system was officially integrated into the regulatory system recognized by the international community The data of clinical trials of new drugs at home and abroad are mutually recognized, and the clinical trials of innovative drugs of domestic pharmaceutical enterprises can also be carried out abroad There are about 14 million new cancer patients in the world and 4.2 million new cancer patients in China every year A guest asked at the scene: "if the data from foreign countries can be directly used, so many patients and so many biological samples of clinical resources in China, this is a huge treasure house of resources Do we want to develop it, is Datong in the world or emphasize the importance of China?" "I think we should base ourselves on some research in China If the research of our own patients is done well, we can not only provide good services to Chinese patients, but also make due contributions to the world," said Shi Yuankai, a clinician According to the data of the former State Food and drug administration, Shi Yuankai pointed out: "from 2013 to July this year, there were more than 1180 CFDA registered clinical studies, a considerable part of which were done by local enterprises in China There were some good large-scale three-phase clinical studies, which were basically done in accordance with the latest international design At the same time, the overall operation quality of the clinical studies was also improved A very big improvement According to sun, in India, the development of clinical trials is regarded as an industry "If we increase investment in this area, it will form an industry, and it will be good for our clinical research and the listing of new drugs, including promoting the health of the Chinese people.".