Covid-19 antigen home self-test is applicable to a wide range of general screening self-test and is an effective supplement to nucleic acid detection. Since the outbreak of covid-19 virus in 2020, the global epidemic prevention and control has remained tense, and there is still a trend of repeated rise. Recently, many countries in Europe, America and East Asia have announced different degrees of epidemic liberalization policies, and residents' general screening demand has gradually ushered in an outbreak. Covid-19 antigen self-test kit can be quickly completed within residents' families without the guidance of professional doctors. The results can be obtained in 15-20 minutes. It can effectively reduce the risk of exposure and reduce the resource occupation of hospitals and third-party laboratories. It is usually used for a wide range of general self-examination of residents. However, due to the lack of methodology, the sensitivity and accuracy of covid-19 antigen self-test are lower than those of nucleic acid detection, and the test results need to be reported by individuals. Therefore, this product is an effective supplement to nucleic acid detection. The rules for the use of antigen self-test in the United States, the European Union, Australia and other places clearly point out that nucleic acid detection methods can be supplemented but cannot be replaced.
The registration and approval of covid-19 antigen self inspection products in China may be stricter, and the product landing still needs to wait for the introduction of formal policies. The clinical requirements of the European Union and the United States for covid-19 antigen self-test kit refer to the interim guidance documents of who, including core indicators such as sensitivity, specificity, positive coincidence rate and negative coincidence rate, but there are no strict regulations on the number of clinical participants; The key points of technical review for the registration of antigen detection reagents proposed by the State Food and drug administration require that the number of enrolled cases may reach 500 according to the preliminary research, which is significantly higher than the reagent development standards of FDA and EU. Referring to the registration and approval of China's in vitro diagnostic kit, we believe that if China's covid-19 antigen self-test kit enters the Innovation Medical Management Co.Ltd(002173) device special review procedure or medical device priority approval process, the approval time is expected to take 3-12 months; If the class III Registration Certificate is applied for according to the conventional in vitro diagnostic reagent, the whole approval process may take 1-3 years. At present, China's relevant quality evaluation requirements and registration evaluation methods have not been released, and the final approval speed still needs further reference to national policies.
China's market space: with reference to overseas distribution policies, it is predicted that China's monthly market size may reach 17.7-26.6 billion yuan. The distribution frequency of overseas covid-19 antigen self-test kits varies significantly, ranging from 2 to 10 times per capita. For example, China's antigen self-test kit has been officially released. According to grassroots research, the ex factory unit price of China's covid-19 antigen self-test kit is about US $1-1.5. The frequency of use refers to overseas policies. It is assumed to be twice a month according to the minimum frequency, calculated according to the total population base of 1.4 billion and the latest US dollar / RMB exchange rate of the central bank, We expect that the market scale of covid-19 antigen self-test kit in China is expected to reach 17.7-26.6 billion yuan per month. Taking into account the purchase by residents and enterprises at their own expense, we expect that the purchase demand of covid-19 antigen detection products is expected to further increase.
Investment suggestion: at present, covid-19 antigen self-test kits of hundreds of in vitro diagnostic manufacturers in China have been registered and approved overseas, and the market competition in Europe, Malaysia and other regions is becoming increasingly fierce. We believe that if the registration approval of covid-19 antigen self-test products in China is released, the head brands with complete and abundant clinical data and relatively large overseas sales may gain advantages. We suggest paying attention to the investment targets of Andon Health Co.Ltd(002432) , Zhejiang Orient Gene Biotech Co.Ltd(688298) , Shenzhen Yhlo Biotech Co.Ltd(688575) , Guangzhou Wondfo Biotech Co.Ltd(300482) , Beijing Hotgen Biotech Co.Ltd(688068) , an Xu biology and so on.
Risk warning events: risk of new product research and development, risk of policy change, risk of intensified market competition, risk of deviation in market space measurement, and risk of delayed information or delayed update of public materials used in the research report.
