Medicine Network August 4th This year is the fifth year of the national drug review reform, as a witness of this reform, Tsinghua University Medical College researcher Chen Xiaoxuan on the reform brought about by the changes in China's innovative pharmaceutical industry is particularly profound.
"Sanduer statistics show that the clinical trial application (IND) review will take approximately 11 months before the drug approval system reform in 2015 and the new drug listing application (NDA) will take about 28 months.
issued in October 2017, "Opinionon on Deepening the Reform of review and approval system to encourage innovation in pharmaceutical devices" (hereinafter referred to as "Opinion"), clinical trial applications have been shortened to within 60 days, and the time for review and approval of priority varieties for new drug listing applications has averaged 12-14 months, nearly half as much as in the past.
," Chen said.
she said that the results of the five-year review and approval show that the safety and quality standards of drugs have not been lowered after speeding up the review and approval, but accelerated approval allows a number of clinically urgently needed domestic innovative drugs to be marketed at an early date, which is of great significance to the health of patients and the sound development of China's pharmaceutical industry.
research and development environment to improve the domestic innovation drug market accelerated Chen Xiaoxuan said that with China's pharmaceutical research and development capacity, the increase of innovative pharmaceutical products, the original review and approval system shows many shortcomings, drug review reform is the inevitable product to promote the development of medicine at this stage. "From 2005 to 2014, a total of three domestically developed innovative drugs were approved in the field of cancer, " said Chen Xiaoxuan,
However, in just three years from 2017 to 2019, 10 domestically-made innovative drugs, including the cancer innovation drug pyridine, were approved for market.
" this change is due to a policy environment that encourages innovation, as well as to China's gradual accumulation of improved research and development capabilities, Chen said.
talking about the course of local enterprises to do new drug research and development, Chen Xiaoxuan feeling that before we were following others mainly to imitation drugs, then to do me-too/me-better imitation drugs, now began to do first-in-class innovative drugs.
in the field of new drug research and development we may still have a certain gap with the international level, but compared with their past, it is certain that we have made great progress compared to the past. "This is the best time to develop new drugs,"
" Chen Xiaoxuan said that the domestic new drug research and development team has gradually developed, the investment environment is also gradually maturing, the national regulatory policy is also tilted towards innovative drugs, cutting-edge innovation technology is also emerging, talent, technology, capital, policies have been available.
industry reshuffle has begun to reform to promote the transformation of pharmaceutical enterprises and differentiation of the field of biomedicine is a relatively high "threshold" of the industry, in Chen Xiaoxuan's view, with the deepening of reform, will certainly promote the domestic pharmaceutical industry pattern of differentiation.
"Seine, which will be listed in 2018, is one of the essential products for breast cancer treatment, after the market was completely monopolized by imported drugs, lacking local products, which are not only expensive, but also risk drug shortages.
therefore, based on the outstanding clinical benefits shown in the early studies of pyridine, the FDA has given accelerated approval to the market, not only to avoid this risk, but also to break the situation of the monopoly of imported drugs.
drug review reform is the hope that this urgent clinical need can be addressed, so that patients benefit early.
" Chen Xiaoxuan for example.
now, more and more domestic new drugs are successfully on the market, but also inspire many people to invest in innovative drug research and development eager to replicate success.
in the drug trial work for more than ten years, Chen Xiaoxuan also felt the happiness and hardship in this field.
", while seeing the benefits of the industry, but also clearly aware of the risks of the industry.
" Chen Xiaoxuan said, to innovative drugs, for example, the development of new drugs not only investment, time-consuming, but also high risk, 100 may not be successful one.
to do this line, professional ability is important, long-term sustained input and persistence is also one of the conditions must be met.
everything has its own law of development, in Chen Xiaoxuan's view, the development process of the domestic pharmaceutical industry is in line with the law of the market.
she made a preliminary description of the future development pattern of the domestic pharmaceutical industry.
Chen Xiaoxuan said that everything is now ready, after a period of time after the merger and reorganization of the big wave of Taobao, the future will be a small number of leading large pharmaceutical companies and small research and development companies coexisting situation, which will also produce specialized in new drug research and development service companies, and there is a clear professional segment.
" large companies will gain a certain market share in the international market, to achieve international development.
small companies that ship small boats and make products that can be sold to large companies with marketing capabilities, or outsourced to service companies.
then occasionally have one or two small companies to grow again.
" Chen Xiaoxuan said that in the future, domestic enterprises can no longer rely on the policy dividends to survive, imported drug prices will also fall significantly.
after the domestic enterprises must stand at the forefront of the international research and development of new drugs, because such a layout has begun.
to open up the pulse of production and research to improve the transformation of clinical results in pharmaceutical research and development, China has a certain gap with the international level, a great reason is that the start is late.
Chen Xiaoxuan believes that the current constraints are mainly clinical researchers are not enough, the combination of production and research is not close.
"do basic science, if only to do experiments, send some high-quality papers, not with the industry, and clinical applications linked, will not really find a change in clinical practice of the scientific problems.
" Chen Xiaoxuan said that the reason why many scientific research reports found targets, proteins, high expression did not translate into clinical results, in the final analysis, because the pulse of production and research has not been opened.
talking about how to get through the pulse of production and research, Chen Xiaoxuan said, to increase the training of basic researchers, so that more people doing basic research with clinical integration, understand clinical needs and market space, to develop what clinical really need.
"Now, there are a lot of people who have this understanding and are trying to go down that path."
" Chen Xiaoxuan said that the reason for such a conclusion is based on the following three aspects of observation to know: First, clinical research talent has a platform to show their talents.
the majority of past clinical medical graduates went to hospitals.
and now, the proportion of clinical researchers recruited by enterprises has increased significantly, and clinical medical graduates can go to pharmaceutical companies to do clinical research and development-related work in addition to hospitals.
some medical colleges and universities have also begun to explore the path of the training of clinicians and scientists, which will certainly improve the lack of clinical research and development personnel to some extent.
The second is that universities and industry cooperation is getting closer and closer.
a lot of new things in foreign countries come out of the school, immediately there is an industrial connection, and the transformation path is also very rich.
at present, there are relatively few such models at present, but it is certain that in recent years, enterprises and universities or research institutes more and more frequent cooperation, including personnel training, basic research funding and so on. The third
is the increasingly professional investment industry.
the investment market segmentation is obvious, with investment companies specializing in biomedicine, and even investors are beginning to pay attention to universities, research institutes to fund early research and development. Can the cooperative mode of
production, learning and research effectively improve the results of scientific research and transformation? Chen Xiaoxuan gave a positive answer.
has been a lot of successful cases in the past have confirmed this, such as anti-HER2 drug research and development, is the result of basic, clinical, industrial cooperation.