Focus on shortcomings in the field of biomedicine, Li Yan, representative of the National People's Congress and President of Qilu Pharmaceutical Group, suggested to
encourage the development and production of biological products for domestic substitution
Suggestions and Suggestions
"Enhancing the independent and controllable ability of the industrial supply chain" is the focus of this year's economic work.
The Central Economic Work Conference held from December 16 to 18, 2020 clarified that the security and stability of the industrial chain and supply chain are the foundation for building a new development pattern.
It is necessary to coordinate the advancement of filling short boards and forging long boards, implement key core technology tackling projects for weak links in the industry, solve a number of "stuck neck" problems as soon as possible, and intensively cultivate and develop more unique skills in the areas of industrial advantage.
Currently, what are the shortcomings facing national biosecurity?
How to solve it?
This series of issues has attracted much attention from outsiders.
Li Yan, a representative of the National People's Congress and president of Qilu Pharmaceutical Group, said in an interview with a reporter from Beijing Youth Daily that imported brands currently dominate the biomedical industry chain in terms of high-end instruments, equipment, and consumables.
She suggested that we should vigorously promote short-board technological breakthroughs and the development of the first set of equipment, and encourage biological product research and development and production companies to make domestic substitutions.
High-end instruments and equipment consumables are mainly imported brands
Beijing Youth Daily: Why do you pay attention to issues in the field of biomedicine?
Li Yan: This is related to the status quo.
At present, biosecurity has become one of the major survival and development threats facing the world and all mankind. We will comprehensively improve the national biosecurity governance capabilities and firmly grasp the strategic positioning of biotechnology as a new economic growth point leading the next round of industrial revolution. It has become the consensus of the country and enterprises to seize the initiative in the development of bio-economy.
In addition, in the context of the epidemic raging around the world and the accelerated reconstruction of the global supply chain and industrial chain, technological innovation has encountered some problems, which have become more common and prominent in the field of biomedicine.
Beiqing Daily: In your opinion, what are the shortcomings in the biomedical industry?
How to make up?
Li Yan: The scale of my country’s biomedicine industry has ranked third in the world, forming four links including R&D, production, circulation, and use, involving R&D outsourcing service companies, universities, scientific research institutions, pharmaceutical companies, raw material suppliers, A complex supply chain system including medical device manufacturing companies, distributors, hospitals, etc.
However, the high-end instruments, equipment, and consumables in the above-mentioned industry chain are currently dominated by imported brands.
The current complex and volatile international economic and trade environment, coupled with the global impact of the new crown epidemic, reminds us to forward-looking layout, vigorously promote short-circuit technological breakthroughs and the development of the first set of equipment, and build a batch of raw material production enterprises and equipment mastering cutting-edge biomedical technology , Instrument manufacturing companies, do a good job in "strong chain", "chain extension" and "chain supplement", and establish a good industrial ecosystem.
Encourage biological product research and development and production companies to make domestic substitutions. When the quality of domestic equipment, instruments, materials and consumables is close to or equal to imported products, domestic brands are preferred.
At the same time, when replacing domestically-made materials with imported materials and equipment in research and on-market products, we will provide legal and policy support from the national level to ensure efficient and rapid realization of localized substitution.
Introduce relevant policies and specific guiding principles, and on the basis of scientific evaluation, to minimize non-essential comparative research requirements for changes made to achieve localization.
Exploring the cause
Innovative research lacks new mechanisms and new targets
Beiqing Daily: What do you think are the current problems?
Li Yan: One is the original innovation shortcoming, and the other is the risk from missing key equipment to shielding technical talents.
New drug development is an interlocking ecosystem. At present, innovative research lacks new mechanisms and new targets with transformative significance.
Beijing Youth Daily: Can you give me an example to explain it in detail?
Li Yan: Take the "tumor immune target" as an example. The tumor immune drugs currently on the market and the targets in clinical development are all discovered by basic scientific research in the United States, Europe and Japan and transformed into product development and research. Domestic foundation is urgently needed. In the field of translational research, the disease mechanisms and targets of tumors and other major diseases that can be turned into drugs have emerged, realizing China's own new breakthroughs in new molecular entities and treatment methods.
In addition, in terms of problems, clinical research resources are also insufficient.
Clinical research is a hurdle for new drug development, and it is also a touchstone for testing the quality of new drug development. Although relevant departments and major hospitals have accelerated the construction of clinical research centers in recent years, the overall quantity and quality need to be improved.
In addition, it is obvious that R&D is concentrated on popular targets, and the phenomenon of homogeneous innovation is widespread.
Beiqing Daily: In addition to original innovation, talent is also the key.
Li Yan: Yes.
At present, the key instruments, equipment, and consumables required for high-end R&D and industrialization in the biopharmaceutical chain are heavily dependent on imports. Once major changes in the international situation occur, domestic core equipment cannot be replaced at present.
Talent is the key to innovation, and international exchanges and reasonable flow of high-end talents should be vigorously promoted.
Text/Reporter Meng Yaxu
Strengthen the top-level design of the pharmaceutical industry
Beiqing Daily: We noticed that last year's Central Economic Work Conference paid great attention to basic research work.
The meeting made it clear that it is necessary to promptly formulate and implement a ten-year basic research action plan.
What is the status of "basic research" in the field of medicine?
Li Yan: Basic medical research is a strategic frontier that many countries attach great importance to. The United States, Britain, France, Japan, Australia and other developed countries have formulated national strategies for biomedicine or life sciences, continued to invest funds, established a research coordination system, and accelerated the seizure of science and technology. Commanding heights.
It is hoped that the government can continue to invest in scientific research funds for a long time and increase the proportion of basic research in the total R&D investment.
Break through the bottleneck of achievement transformation, explore the establishment of a National Translational Science Promotion Center, and build a bridge from basic medicine to clinical research.
At the same time, encourage and support the development of new targets and products that are at the forefront of the world and are at the forefront of global technology, and promote a new generation of antibody combination technology, innovative dual-target antibody technology, oncolytic virus, high-concentration biological product subcutaneous drug delivery technology, The development of oral biological preparations.
Especially for the products under research that enter the clinical stage, we will provide strong support from the national perspective with policies and funds.
Beiqing Daily: In your opinion, how to solve the shortcomings of biosafety in these countries?
Li Yan: I suggest strengthening the top-level design of the pharmaceutical industry, accelerating the cultivation of industry leaders, promoting industrial upgrading, and building a strong pharmaceutical country as soon as possible.
In addition, approval is critical to pharmaceutical innovation. The day before the market is listed, a large amount of investment will be returned as early as possible, but it can sometimes become a "bottleneck."
The New Drug Administration Law has taken a series of measures to improve pharmaceutical innovation, but compared with the international advanced, and the review time of imported drugs and domestic innovative drugs, there is still a lot of room for improvement.
It is recommended to continue to reform the review, review and approval system, improve the quality and efficiency of review and approval, reduce administrative approval, and assign more responsibilities to enterprises, institutions and markets while ensuring safety.