Academician Liu Changxiao: Chinese Biomedicine Enters the "Fast Track"

new crown outbreak is the world's most noteworthy public health event in 2020, and it is bound to go down in human history. From the publication of the whole genome sequence of the new coronavirus to the research and development of the viral nucleic acid testing kit, from the development of antiviral drugs to the listing of the new coronavirus vaccine, Chinese scientists have always adhered to the front line of anti-epidemic, and actively promoted China's biopharmaceutical industry into the "fast lane".to build a new coronavirus basic research and technology platform is the key to drug and antibody research and development. Chinese scientists took the lead in analyzing the three-dimensional structure of the important proteins of the new coronavirus, constructed a three-dimensional model of the new coronavirus, and created a SARS-CoV-2-related animal model, which plays an important role in clarifying the pathogenesis of the disease, the route of transmission and the host immune response, and is also the basis for evaluating the effectiveness of the vaccine and the role of drugs.
December 30, 2020, China's new crown inactivated vaccine was approved with conditions for listing, no doubt for the new crown epidemic prevention and control provides a powerful weapon. At present, China's simultaneous promotion of inactivated vaccine, recombinant protein vaccine, adenovirus vector vaccine, anti-virus virus vector vaccine and nucleic acid vaccine 5 technical routes, there have been 14 new crown vaccine into clinical trials, of which 3 technical routes of 5 vaccines into the international multi-center Phase III clinical trials. It also provides strong support for our commitment to vaccines as a global public product and a strong confidence in the global fight against the epidemic.
2020, the State Drug Administration received 828 applications for registration of domestically produced 1 class of innovative drugs, and finally approved 14 new drugs of 1 class. According to the drug type statistics, 574 chemical drugs, 254 biological products, from the field of treatment, tinib anti-cancer drugs 4, antiviral preparations 3. Both new drug applications and new drug approvals have been on the market for nearly a decade.
can say that China's new drug development from "China's new" to "the world's new" has taken a big step forward, which is undoubtedly the greatest benefit to national health protection. But for new drug research and development companies, there is still a need to redouble efforts on how to quickly launch high-quality new drugs with obvious differences and achieve the goal of a new drug powerhouse.particularly noteworthy is that Chinese medicine has played an important role in the new crown epidemic, but also its industrialization and development provides a good opportunity. In February 2020, the central leadership group to deal with the outbreak of neo-crown pneumonia called for strengthening the integration of Chinese and Western medicine, promoting the deep involvement of Chinese medicine in the whole process of diagnosis and treatment of neo-crown pneumonia, and timely promotion of effective prescriptions and traditional Chinese medicines.
, the local drug regulatory authorities accelerated the approval of hospital preparations. The State Administration of Traditional Chinese Medicine urgently launched the "prevention and treatment of new coronavirus infection of pneumonia effective prescription screening research" special, and finally the three parties (clear lung detox soup, wet detox, declared lung detox) three drugs (golden flower clear particles, even flower clear plague particles and capsules, blood must be net injection) included in the new coronary pneumonia treatment guidelines.
addition, these prescriptions after double-blind comparative clinical trials or Western drug joint comparative trials, for patients with neo-coronary pneumonia clinical symptoms to improve, reduce the amount of anti-infective drugs, block the exacerbation of the disease has a certain effect. This has laid a scientific foundation for China to formulate a new strategy for the prevention and control of coronary pneumonia, a variety of interventions, the combination of China and the West and give full play to the unique advantages of Chinese medicine.present, China's new crown pneumonia epidemic prevention and control work has changed from emergency state to normal, thanks to the country's scientific decision-making and deployment of epidemic prevention and control work and unremitting efforts up and down the country.
in the drug review and approval, the country mainly has the following reform measures: First, to serve the epidemic prevention and control needs, speed up the review and approval. For the epidemic prevention and control treatment-related drugs and medical devices and other technical products, coordination to promote access to emergency review and approval of the green channel.
, the opening of breakthrough treatment channels to promote the innovative development of Chinese drugs based on clinical needs. In July 2020, the State Drug Administration launched the Breakthrough Therapeutic Drug Procedure Application System and the new "Priority Review and Approval Application System", which opened an electronic submission channel. The first publicity of the "Breakthrough Treatment Publicity" column marks the official launch of this special review channel in China. This initiative is bound to accelerate the process of listing drugs with clinical advantages in China, which is of great significance to meet the clinical treatment needs of major diseases in China and encourage innovation.
third, support new technology and new product development. Many prevention and control projects to obtain national and provincial prevention and treatment of new crown pneumonia science and technology special emergency projects. In addition, relevant state institutions reward newly developed products and varieties in various forms, subsidize research and development investment and subsidize enterprises with major functional innovation platforms, and actively provide clinical research services to medical institutions.
fourth, supporting the industrialization of research and development. In addition to subsidizing the production of epidemic prevention and control shortage materials enterprises, encouraging enterprises to participate in the upstream and downstream cooperation of epidemic prevention and control, the state will also be in the treatment line to get practical application, play an important role, make outstanding contributions to the new projects into the project support system, and finally establish the epidemic prevention and control products fixed-point supply system to support new technologies and product applications.After the construction of the first four five-year plan (2001-2020), china's biomedical development has entered the ranks of the world's second echelon, in the field of biotechnology synthetic biology, gene editing and other research has achieved global attention to innovation, for the gradual cultivation of leading the world's pharmaceutical technology and industry laid a foundation.
summary, there are three main basic studies related to pharmaceutical innovation in 2020:
the main protease of the new coronavirus. It is urgent to analyze the three-dimensional structure of the key drug targets of the new coronavirus, reveal the important characteristics of the drug targets, and develop special effects drugs. The main protease of the new coronavirus has a key regulatory role in the life cycle of the virus and is a high-profile drug target. China has taken the lead in analyzing the high-resolution three-dimensional structure of the key drug target protease and inhibitor complex of the new coronavirus, and has laid an important foundation for the research and development of old drugs or clinical drugs such as Ib selenium and double thiolyn, as well as anti-new crown drugs.
to build a new animal model of coronary pneumonia. In the prevention and control of the new crown epidemic, animal model is one of the five main directions of scientific research, and it is also the basic research work to clarify the pathogenic mechanism and transmission pathway, screen drugs and evaluate vaccines. Chinese scientists have successfully solved three key problems of molding, namely, animals sensitive to the new coronavirus, the development of reagents to detect viruses in animals, and the accurate simulation of the clinical manifestations of disease in animals.
antigen-subject signal transducting mechanism and its application in CAR-T therapy. CAR-T cell therapy has been successfully applied to the clinical treatment of tumors, but faces challenges such as cytokine release syndrome and low cell sustainability. The signal element of car comes from the chain of the antigen CD3ζ and co-stimulating molecules. At present, the researchers' modification of CAR mainly focuses on the co-stimulation signal element, while ignoring the antigen signal element. Through quantitative mass spectrometography and bio-chemical methods, Chinese scientists have discovered that TCR's CD3ζ chain has a special signal transducting function, which can recruit both the inhibitory molecule Csk and the active molecule PI3K. Adding CD3ζ inoculocytes to clinically used CAR sequences can make CAR-T cells more sustainable, more anti-tumor, and reduce the risk of cytokine release syndrome.