Event: in March 11, 2022, the national Wei Jian administration website released the "COVID-19 virus antigen detection application plan (Trial Implementation)" (hereinafter referred to as the "plan"), in order to further optimize the COVID-19 virus detection strategy, and serve the epidemic prevention and control needs, the State Council should decide on the basis of nucleic acid detection for the comprehensive group of New Coronavirus pneumonia epidemic prevention and control mechanism. Add antigen detection as a supplement to promote the monitoring mode of "antigen screening and nucleic acid diagnosis".
Event comments:
The plan stipulates three categories of applicable groups and formulates the follow-up disposal management process. First, those who go to grass-roots medical and health institutions with respiratory tract, fever and other symptoms within 5 days; Second, isolate observers, including those in home isolation observation, close connection and secondary close connection, entry isolation observation, sealing and control area and control area; Third, community residents who need antigen self-test. At the same time, the main conditions to be met for antigen detection of the three groups and the access to detection reagents were clarified, and the disposal management process after positive detection was formulated to promote the connection between antigen detection and nucleic acid detection. In order to facilitate standardized testing in various regions, the plan also includes two annexes, namely, the basic requirements and procedures for covid-19 virus antigen testing in grass-roots medical and health institutions, and the basic requirements and procedures for covid-19 virus antigen self-testing.
Antigen detection is fast. In the case of large-scale epidemic and rapid virus transmission, it is more conducive to the "early detection" of covid-19 virus infected persons. In the face of large-scale epidemic and the increase of covid-19 virus transmission speed, the number of test samples increases sharply, and the lag of nucleic acid test results has brought some difficulties to epidemic prevention and control. Antigen detection is based on the principle of immunology. It has the characteristics of high specificity, high sensitivity, fast detection speed and wider application scenarios. Generally, the detection results can be obtained in 15 to 20 minutes, and the operation is more convenient. There is no need for professionals to process the samples, and there are no more stringent requirements for the detection environment. Compared with nucleic acid detection, antigen detection has the advantages of fast detection speed, convenient operation and wider application scenarios. However, nucleic acid detection is still the gold standard for covid-19 diagnosis. As a supplement, antigen detection can achieve the purpose of rapid detection and early detection of virus infected persons.
10 antigen detection reagents have been approved in China, and listed companies in relevant industrial chains will benefit.
On March 12, the State Food and Drug Administration issued a notice approving the change of covid-19 antigen product self-test application of Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) , Beijing jinwofu, Shenzhen Huada Yinyuan, Guangzhou Guangzhou Wondfo Biotech Co.Ltd(300482) , Beijing huaketai biology. Five covid-19 antigen self-test products were officially launched. On March 13, the State Food and Drug Administration issued a notice again, approving covid-19 antigen detection test of Beijing Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) , Beijing Lepu diagnosis, Beijing Beijing Hotgen Biotech Co.Ltd(688068) , Tianjin boosses and Chongqing Mingdao Jietai. As of March 14, 2022, 10 covid-19 antigen detection reagent products have been officially listed in China, involving 10 enterprises, of which 6 are A-share listed companies. Antigen detection reagents have been approved and used abroad for a long time. Antigen detection products of many Chinese enterprises have also been approved and sold in Europe, America and other countries. With the popularization and application of antigen testing in China, it is expected that companies that have obtained foreign certification will accelerate the registration and listing of their antigen testing products in China.
The three categories of people specified in the plan include community residents with antigen self-test needs, and offline pharmacies and online sales platforms will benefit. Community residents who need self-test can purchase antigen test reagents for self-test through retail pharmacies, online sales platforms and other channels. With the gradual promotion of antibody testing, relevant retail pharmacies and online sales platforms will also benefit. Currently, listed offline drugstores in China include Yifeng Pharmacy Chain Co.Ltd(603939) ( Shuyu Civilian Pharmacy Corp.Ltd(301017) . SZ).
Investment suggestions:
With the official release of covid-19 virus antigen detection application scheme (Trial), antigen detection will be popularized and applied on a large scale in China, resulting in a large amount of antigen self-test products and performance increment for relevant antigen self-test reagent manufacturers. At the same time, with the promotion of residents' self-test, offline pharmacies and online sales platforms will also benefit. It is suggested to focus on the investment opportunities of 6 listed companies that have obtained the certification of Chinese antigen detection products and foreign certified companies, pay attention to the distribution of offline pharmacies and online sales platforms and the cooperation with manufacturers of antigen detection products, and focus on the investment opportunities of head pharmacies.
Risk tips:
Risk of price reduction of antigen detection products; Covid-19 epidemic situation is repeated; The policy promotion was not as expected.
