Strengthen the integration of production, education and research to promote the transformation of innovative drug achievements

This year is the fifth year of the national drug review reform. As a witness to this reform, Chen Xiaoyuan, a researcher at the School of Medicine of Tsinghua University, feels particularly profound about the changes brought about by the reform in my country's innovative drug industry.
"According to public statistics, before the reform of the drug approval system in 2015, clinical trial application (IND) review took about 11 months, and new drug application (NDA) took about 28 months. The two offices issued documents in October 2017 After the release of the "Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices" (hereinafter referred to as the "Opinions"), the implementation of implied approval for clinical trials has been shortened to less than 60 days, and the review and approval of priority varieties for new drug applications The average time is 12-14 months, which is nearly half shorter than before." Chen Xiaoyuan said.
She said that the results of the review and approval in the past five years have shown that the safety and quality standards of the drug have not been reduced after the speed of the review and approval, but the accelerated approval has allowed a batch of clinically urgently needed domestic innovative drugs to be marketed as soon as possible, which is beneficial to the health of patients. It is of great significance to the sound development of my country's pharmaceutical industry.
Improving the R&D environment and accelerating the launch of domestically produced innovative drugs
Chen Xiaoyuan said that as my country's pharmaceutical research and development capabilities increase and innovative drug products increase, the original review and approval system has shown many shortcomings. Drug review reform is an inevitable product of promoting the development of medicine at this stage.
Chen Xiaoyuan said: “From 2005 to 2014, a total of three domestically developed innovative drugs were approved in the field of oncology. However, in just three years from 2017 to 2019, there have been breast cancer innovative drugs including pyrrotinib. Of 10 domestically produced innovative drugs were approved for listing."
For this change, it has benefited from the policy environment that encourages innovation and China's gradual accumulation and improvement of research and development capabilities, Chen Xiaoyuan analyzed.
Speaking of the development of new drugs by local companies, Chen Xiaoyuan said with emotion that in the past, we followed others and mainly focused on generic drugs, then made me-too/me-better generic drugs, and now we are starting to do first-in. -class innovative medicine. In the field of new drug research and development, we may still have a certain gap with the international level, but compared with our own past, we can be sure that we have made great progress compared to the past.
"Now is the best time for new drug research and development." Chen Xiaoyuan said that the domestic new drug research and development team has gradually developed, the investment environment has gradually matured, the national regulatory policy has also tilted towards innovative drugs, and cutting-edge innovative technologies have continued to emerge. Talent, technology, Capital and policies are already available.
Industry reshuffle has begun, reforms have promoted the transformation and differentiation of pharmaceutical companies
The biomedical field is an industry with a relatively high "threshold". In Chen Xiaoyuan's view, with the deepening of reform, it will inevitably lead to the differentiation of the domestic pharmaceutical industry.
"Take pyrrotinib, which went on the market in 2018, as an example. Anti-HER2 therapy is one of the indispensable products for breast cancer treatment. Prior to this, the market in this field was completely monopolized by imported drugs and lacked local products. It was not only expensive, but also The risk of drug shortages. Therefore, based on the outstanding clinical benefits shown in the early studies of pyrrotinib, the Food and Drug Administration granted accelerated approval to market, which not only circumvented this risk, but also broke the monopoly of imported drugs. The reform of drug review is It is hoped that this urgent clinical need can be solved and patients can benefit early." Chen Xiaoyuan gave an example.
Nowadays, more and more domestically produced new drugs are successfully listed, which also encourages many people to invest in innovative drug research and development, eager to replicate successfully. Having worked in drug review for more than ten years, Chen Xiaoyuan has also experienced the happiness and difficulties in this field.
“While seeing the dividends brought by the industry, we must also clearly recognize the risks in the industry.” Chen Xiaoyuan said that taking innovative drugs as an example, the research and development of new drugs is not only expensive, time-consuming, and risky. It may not be possible in 100 1 success. To do this, professional ability is important, and long-term continuous investment and persistence are also one of the necessary conditions.
Everything has its own development law. In Chen Xiaoyuan's view, the development process of the domestic pharmaceutical industry is in line with the market law. She made a preliminary description of the future development pattern of the domestic pharmaceutical industry.
Chen Xiaoyuan said that everything is ready now. After a period of large-scale mergers and acquisitions, a small number of leading large pharmaceutical companies and small R&D companies will coexist in the future. Service companies specializing in new drug research and development will also emerge. A clear professional breakdown appears.
"Large companies will gain a certain market share in the world and achieve international development. Small companies can make a turn around and sell products to large companies with marketing capabilities, or outsource them to service-oriented companies. Then occasionally there will be one or two small companies to grow and develop." Chen Xiaoyuan said that in the future, domestic companies will no longer be able to survive on policy dividends, and the prices of imported drugs will also drop sharply. In the future, domestic companies will definitely have to stand at the forefront of international research and development of new drugs, because such a layout has already begun.
Open up the industry-university-research network to improve the transformation of clinical results
In terms of pharmaceutical R&D, the reason why China has a certain gap with the international level is that it started late. Chen Xiaoyuan believes that the current constraints are mainly the shortage of clinical scientific research personnel and the inadequate integration of production, education and research.
"For basic science people, if they just concentrate on doing experiments and publish some high-quality papers, and are not associated with industry and clinical applications, they will not really discover scientific problems that can change clinical practice." Chen Xiaoyuan said, The reason why the targets, proteins, and high expressions found in many scientific research reports have not been transformed into clinical results, in the final analysis, is because the context of industry, university and research has not been opened up.
Talking about how to open up the line of production, education and research, Chen Xiaoyuan said that it is necessary to increase the training of basic scientific research personnel, so that more people doing basic research can integrate with the clinic, understand the clinical needs and market space, and develop what the clinic really needs.
"Now, many people have this kind of understanding and are working hard to follow this path." Chen Xiaoyuan said that the reason for this conclusion is based on the following three observations:
One is a platform for clinical scientific research talents to display their talents. In the past, most of the clinical medicine graduates were employed in hospitals. Nowadays, the proportion of clinical scientific research personnel recruited by companies has risen sharply. In addition to hospitals, clinical medicine graduates can also go to pharmaceutical companies to do clinical research and development related work. Some medical schools have also begun to explore the training path of clinicians and scientists, which is bound to ameliorate the shortage of clinical research and development personnel to some extent.
 
Second, the cooperation between universities and industry is getting closer. After many new things come out of schools abroad, industries will be connected immediately, and there are also rich paths for the transformation of results. At present, there are relatively few such models in China, but it is certain that in recent years, the cooperation between enterprises and universities or scientific research institutes has become more and more frequent, including personnel training and basic research funding.
Third, the investment industry is becoming more professional. The investment market is clearly segmented. There are investment companies that specialize in the field of biomedicine, and some investors have even begun to pay attention to early research and development funded by universities and research institutes.
Can the industry-university-research cooperation model effectively improve scientific research transformation results? Chen Xiaoyuan gave a positive answer. Many successful cases in the past have confirmed this. For example, the research and development of anti-HER2 drugs is the result of basic, clinical, and industrial cooperation.