Event:
On March 11, 2022, the comprehensive group of the joint prevention and control mechanism of the State Council decided to promote the monitoring mode of “antigen screening and nucleic acid diagnosis”, print and issue the application scheme for covid-19 virus antigen detection (Trial), and add antigen detection as a supplement on the basis of nucleic acid detection. On March 12, the State Food and Drug Administration approved the application change of covid-19 antigen detection products of Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) , Beijing jinwofu, Shenzhen Huada Yinyuan, Guangzhou Guangzhou Wondfo Biotech Co.Ltd(300482) , Beijing huaketai biology. In March 13th, Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) , Beijing Hotgen Biotech Co.Ltd(688068) , Le Pu diagnostics, Boho Seth and Ming Dao bio 5 approved the New Coronavirus (2019-nCoV) antigen detection kit.
Comments:
The application scope of covid-19 antigen has been expanded, and 10 enterprises have been approved
China has approved covid-19 antigen detection products for screening. At present, they are applicable to three scenarios: 1) primary medical institutions can use antigen detection without nucleic acid detection. If they are negative, antigen detection can be carried out once a day for five consecutive days from the date of treatment. 2) On the basis of the original nucleic acid scheme, the isolated observation population, close contact, secondary close contact, sealing and control area, entry isolation management and other personnel shall detect the antigen once a day in the first five days. 3) Community residents can purchase through retail pharmacies, online sales and other platforms. Symptomatic patients, whose antigen test is negative and it is inconvenient to go to medical institutions for nucleic acid test, can be isolated at home, and antigen test is conducted once a day for five consecutive days. At present, a total of 10 companies’ New Coronavirus antigen detection kits have been approved. Among them, the first batch of 5 companies have obtained COVID-19 antigen detection and detection changes. They are Guangzhou Wondfo Biotech Co.Ltd(300482) , Nanjing Vazyme Biotech Co.Ltd(688105) , Bgi Genomics Co.Ltd(300676) , Beijing golden Wolfe and Beijing Hua Ketai. 5 companies have obtained professional version of COVID-19 antigen test registration certificate (mainly for medical institutions). This change is expected to further expand the scope of application.
Antigen detection is a supplementary means of nucleic acid detection to further improve the efficiency of epidemic prevention and control
According to the existing prevention and control strategies, we believe that antigen detection is a supplementary means and can not replace the results of nucleic acid detection. Nucleic acid detection is still the gold standard. The opening of antigen detection range is mainly used to deal with the characteristics of rapid transmission of covid-19 mutant strain Omicron, control the source of infection in a short time and further improve the efficiency of epidemic prevention and control. The liberalization of antigen detection scene is not completely equivalent to the liberalization of China’s epidemic prevention policy. At present, China’s epidemic prevention policy is still “dynamic clearing”, and there are still high-risk groups such as epidemic investigation, tracking and diagnosis personnel and close contact personnel. The liberalization of European and American countries adopts covid-19 antigen self-test, independent scanning and declaration, and does not actively track infected personnel. According to the research of science, the prevalence of covid-19 has different effects on antigen detection. When the prevalence of covid-19 in the population decreases, the number of false positives and false negatives of antigen detection kits will increase and decrease. Therefore, from the perspective of epidemic prevention and control, antigen detection is more suitable for screening in key populations or key places with certain risks.
Covid-19 antigen detection market scale prediction needs further observation on dosage and price
From the perspective of the sales mode corresponding to the covid-19 antigen detection scenario, the first scenario (primary medical and health institutions) and the second scenario (isolated observers) are expected to be mainly government procurement, and the third scenario (community residents with antigen self-detection needs) is expected to be mainly at their own expense. At this stage, the epidemic situation in China is relatively complex, the product competition pattern changes rapidly, and there is no early reference information. The future antigen detection market space can not be accurately predicted. Referring to the overall overseas testing volume, the average daily testing volume per 1000 people in most overseas countries in 2021 will be about 2-5 times (the phased testing volume in some countries or regions can reach 10-25 times). If China average 3 times per 1000 people per day, the annual testing demand will be 1.4 billion. However, due to the short approval time of antigen testing products, The usage scenario and dosage need to be further observed. From the perspective of price, the official pricing of various products has not been announced yet. In the medium term, referring to the price of nucleic acid and antibody in China, the price of single copy of 10 mixed and 1 mixed test is 10 yuan. However, due to the high short-term demand, the price of antigen detection products is expected to be relatively high.
Investment suggestion: covid-19 epidemic is expected to coexist with humans in the medium and long term, and the trend of the epidemic is highly uncertain. It is suggested to screen theme investment opportunities from three dimensions: 1) good demand sustainability, 2) better competition pattern, and 3) traditional business has certain valuation support. It is suggested to pay attention to relevant subjects: Guangzhou Wondfo Biotech Co.Ltd(300482) , Nanjing Vazyme Biotech Co.Ltd(688105) , Bgi Genomics Co.Ltd(300676) , Beijing Hotgen Biotech Co.Ltd(688068) , Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) , Lepu biology, anxiu biology, Hangzhou Biotest Biotech Co.Ltd(688767) , Hangzhou Alltest Biotech Co.Ltd(688606) .
Risk warning: covid-19 antigen detection quantity and price are uncertain, and the progress of kit approval is lower than expected.
