China's pilot scheme for antigen detection was released to supplement nucleic acid detection and improve the ability of "early detection". On March 11, the comprehensive group of the joint prevention and control mechanism of the State Council formulated and issued the application scheme for covid-19 virus antigen detection (Trial), which is supplemented by antigen detection on the basis of nucleic acid detection. Applicable population: 1) people in grass-roots market with respiratory tract, fever and other symptoms within 5 days; 2) Isolation and observation personnel, including personnel in home isolation, close connection and secondary close connection, entry isolation and observation, sealing and control area and control area; 3) Community residents who need antigen self-test; Testing scheme: 1) primary medical institutions: people with positive antigen test need to report to disease control immediately; 2) Isolation Observer: test once a day in the first five days and report the results. If the antigen is positive, nucleic acid test must be carried out immediately; 3) Residents with self-monitoring needs can purchase by themselves through pharmacies, online sales platforms and other channels, and antigen positive needs to be reported; Procurement method: 1) primary medical institutions, provincial bidding; 2) Isolate observers, and the management department (community, isolation point, etc.) is responsible for procurement; 3) Self monitoring residents, self purchase. As a supplementary means, antigen detection can be used for screening of specific populations to improve the ability of "early detection".
The application of antigen detection is mature, and the key role of antigen in anti epidemic continues to highlight. The specificity and sensitivity test results have been verified, and the application of antigen detection products is mature. The antigen detection products in the European common list are required to meet the minimum performance requirements of sensitivity ≥ 90% and specificity ≥ 97%. At present, the products listed in the list basically exceed this standard in terms of specificity and sensitivity, and the performance indicators of antigen reagents in China are in line with or even exceed those of foreign-funded products. Antigen detection has been widely used in the European Union and the United States for a long time. The extensive use of products has been mature, which has formed a practical verification of the effect of epidemic prevention and control. Antigen detection rushed to Hong Kong. As of March 11, the cumulative reported positive cases of nucleic acid / antigen were 598000 / 64000 respectively, further highlighting the necessity of antigen as a means of nucleic acid supplement.
In the "post mutation period", the epidemic situation in China is multi-point and high, and the antigen detection may start a self-test scale of 100 billion. The Omicron strain is prevalent on a large scale. Recently, there are about 1.5-2 million new cases worldwide every day, and the global epidemic situation is still severe. Since mid February, the epidemic situation in China has been sporadic to multiple. Chinese antigen enterprises are exported to the world and continue to be authorized and approved for listing in the European and American markets. Five Chinese antigen products of Aikang biology, Andon Health Co.Ltd(002432) , Zhejiang Orient Gene Biotech Co.Ltd(688298) , Andon Health Co.Ltd(002432) (non OTC) and Kurt technology won the US fdaeua. In 2021, China's covid-19 antigen reagent exports totaled 56.732 billion yuan. Antigen exports worldwide continued to contribute excess income to antigen enterprises. According to our calculation, the annual antigen detection scale is about 84 billion to 168 billion according to the ex factory caliber. At present, only five antigen enterprises' self-test products such as Wanfu medical, Bgi Genomics Co.Ltd(300676) , Nanjing Vazyme Biotech Co.Ltd(688105) and so on have been approved in China. We believe that China's antigen self-test products may start the rapid registration and approval process, accelerate the listing of multiple products and open up 100 billion market space for antigen detection in China.
Investment suggestion: China's antigen detection has been launched for trial. Antigen detection has been officially recognized as a detection method in developed countries such as Europe and the United States, and its sensitivity and sensitivity have been verified. Superimposed on the key role played by antigen self-test products in Hong Kong's anti epidemic this time, China's antigen detection products, especially family self-test products, are expected to be in large quantities quickly, Optimistic about the three main investment lines of antigen detection industrial chain:
1) production-oriented enterprises: focus on the approved Guangzhou Wondfo Biotech Co.Ltd(300482) , Nanjing Vazyme Biotech Co.Ltd(688105) and enterprises that are expected to be approved in the next batch, such as Zhejiang Orient Gene Biotech Co.Ltd(688298) , Hangzhou Biotest Biotech Co.Ltd(688767) , an Xu biology, Hangzhou Alltest Biotech Co.Ltd(688606) , Andon Health Co.Ltd(002432) , etc;
2) channels: companies with e-commerce channels, such as Jiangsu Yuyue Medical Equipment And Supply Co.Ltd(002223) , Cofoe Medical Technology Co.Ltd(301087) and pharmacies, such as Lbx Pharmacy Chain Joint Stock Company(603883) , Dashin, Yifeng Pharmacy Chain Co.Ltd(603939) , Yixintang Pharmaceutical Group Co.Ltd(002727) , etc;
3) upstream enterprises: antibodies such as Nanjing Vazyme Biotech Co.Ltd(688105) , Sino Biological Inc(301047) , Acrobiosystems Co.Ltd(301080) , and related accessories (swab + liquid tube) such as Zhejiang Gongdong Medical Technology Co.Ltd(605369) , Shenzhen Changhong Technology Co.Ltd(300151) , etc.
Risk warning: the risk of policy change, the approval of product registration is less than expected, and the market competition intensifies the risk.
