Top Ten Development Hot Words Of China'S Big Health Industry In 2020

21 senior researcher of new Institute of health Zhu Ping, Tang Weike, Lu Shan, Chen Hongxia, Xu Xu

New crown vaccine

Data reading: according to the data published on the World Health Organization website, as of December 29, 2020, there are 232 kinds of new crown vaccines in the world, of which 60 kinds have entered the stage of clinical trials. Of the 15 vaccines in phase III clinical trials, China accounts for five.

At present, four new crown vaccines have been approved in the world: Pfizer / Germany new biotechnology mRNA vaccine, Modena mRNA vaccine, AstraZeneca Oxford University adenovirus vaccine and China National Pharmaceutical Group inactivated vaccine. Among them, Pfizer mRNA vaccine has been approved for use in more than 40 countries, and it is planned to produce 1.3 billion doses by 2021.

21 new health research institute analysis: vaccine is generally considered as the "termination key" of infectious disease pandemic, and the new crown vaccine can be regarded as the fastest and most developed vaccine in the history of human vaccine research and development.

In the face of the epidemic, the world is racing against death. In terms of vaccine research and development time, it has also increased from "10-15 years" in the past to "the fastest 18 months" now. Compared with domestic and foreign vaccines, there are obvious differences in the research and development route. Domestic research and development of inactivated virus vaccine accounts for a high proportion, and mRNA vaccine is the focus of foreign efforts. The inactivated virus vaccine has rapid action but low antigenic specificity. It takes only 40 days to produce the mRNA vaccine, which does not need a long time to select strains. It has a unique time advantage, but its research and development technology threshold and requirements are high, and its safety and effectiveness are difficult to guarantee.

On December 30, 2020, the State Food and Drug Administration of China approved the registration application of new coronavirus inactivated vaccine of sinopharma Group China biology Beijing company. The results of phase III clinical trial analysis showed that the vaccine had good safety after vaccination. After two injections, all subjects produced high titer antibody, and the positive conversion rate of neutralizing antibody was 99.52%, and the protective effect on covid-19 was 79.34%. This figure is far higher than the standard of no less than 50% proposed by the World Health Organization. The higher the protective effect of the vaccine, the faster and more efficient mass immunization can be achieved.

By the end of December 2020, China has received more than 3 million doses of vaccines, of which about 60000 people have gone to work in high-risk areas abroad, and no serious infection cases have been reported. The safety and effectiveness of the vaccine have been fully proved.

The success of the research and development of China's new crown vaccine is not accidental. It is not the result of pure market evolution, nor is it the result of concentrating on major events in the traditional sense. It depends on the interaction of two factors: one is that the market mechanism and the interests of enterprises are recognized; the other is that the state gives full play to its institutional advantages to carry out political mobilization, which is a new nationwide system based on respect for the market. In other words, knowledge accumulation and policy support are only static results, and the R & D of new crown vaccine benefits from the collaborative system and its operation.

Nucleic acid detection

Data reading: from the beginning of 2020 to March 12, the State Food and drug administration has approved a total of 16 new coronal pneumonia detection reagents, including 10 nucleic acid detection reagents and 6 antibody detection reagents. Among them, the daily capacity of nucleic acid detection reagent is nearly 2.6 million copies, and the daily capacity of antibody detection reagent is close to 1 million. According to the statistics of the General Administration of customs, from March last year to the end of the year, China exported 1.08 billion copies of new coronavirus detection kits.

21 new Institute of health analysis: at the beginning of 2020, the outbreak of Xinguan epidemic, the increase of confirmed and suspected cases, and the serious shortage of medical supplies, nucleic acid detection kit plays a crucial role in winning the battle against the epidemic. In this context, IVD industry also staged a great change.

On January 26, 2020, the State Food and Drug Administration announced that four new coronavirus detection products of four enterprises were approved for emergency approval; two new coronavirus 2019 ncov nucleic acid detection kit (fluorescent PCR method) products of two enterprises were approved again on January 28; and one product of one enterprise was approved again on January 31. A total of seven enterprises have been audited within a week. Taking the first batch of approved Zhijiang biological products as an example, from the beginning of research and development to the approval of the state, a variety of work was carried out at the same time, which only took less than 20 days, reflecting the "China speed".

On February 3, the Ministry of industry and information technology said that on February 1, the daily production of reagents had reached 773000, 40 times that of suspected patients, and the recovery value of production capacity reached 60-70%. The situation of "one box is difficult to obtain" has been improved, and the supply of nucleic acid detection kits has basically met the requirements.

In March, the development of domestic epidemic situation entered a new stage, and the production capacity of domestic nucleic acid detection kit was further improved. Subsequently, on April 8, Wuhan fully restarted, and the domestic epidemic gradually entered the stage of normalization. On August 5, the Ministry of industry and information technology said that China's weekly production capacity of nucleic acid detection reagents reached 46.48 million, and the weekly production capacity of nucleic acid detection equipment reached more than 1200 sets. Moreover, the sensitivity of nucleic acid detection reagents has been improved, and the detection time has been shortened. The total detection rate of nucleic acid detection reagents has reached more than 95%.

According to the traditional method, it took more than 4 hours for a test before, but now it can be completed in about an hour. Among them, the fastest product can give results in 30 minutes, and the integrated detection of "sample in and result out" can be realized.

At the same time, the domestic in vitro detection kits ushered in the "export tide". As of May 11, 164 domestic IVD enterprises have obtained export qualification. Among them, 7 have obtained US EUA certification, 154 EU CE certification and 3 Australian TGA certification. In November, the number rose to 446.

China's IVD industry started late, technology is backward, and the market demand awareness is relatively lacking. However, the outbreak of Xinguan has stimulated the release of domestic IVD industry development momentum, and naturally made up for the lack of public awareness, thus promoting the domestic trend of IVD industry. (Editor: Xu Xu)

Due to the limited space, only part of the report is selected. For the full text of the report, please refer to 21app and 21 new health public number.