Event: in the evening of March 11th, the national health and Health Committee announced that after the study, the State Council, in response to the comprehensive prevention and control mechanism of New Coronavirus pneumonia, decided to increase the antigen detection on the basis of nucleic acid detection, and formulated the “COVID-19 virus antigen detection application plan (Trial Implementation)”.
Covid-19 virus antigen detection was approved and became a powerful supplement to nucleic acid detection. Antigen detection has the characteristics of convenience, timeliness, low cost and low accuracy. It is easier to popularize and realize home self-test. However, the probability of missed detection and false detection is higher, which can not replace the gold standard of “nucleic acid detection” and can not be used as the basis for diagnosis. Therefore, carrying out antigen detection is conducive to early detection. Adding a fast screening method before nucleic acid detection has become a powerful supplement to epidemic prevention, control and screening. At the same time, for medical and health institutions that do not have the ability of large-scale nucleic acid detection, antigen detection, as a means of early screening, can greatly improve the detection efficiency. Referring to foreign experience, China’s liberalization of antigen detection is mainly to comply with the development trend of the epidemic, promote the monitoring mode of “antigen screening and nucleic acid diagnosis”, and improve the ability of “early detection” in the process of rapid virus transmission. Recently, Omicron covid-19 virus has spread rapidly in China, and a large-scale local epidemic has occurred in Shenzhen, Shanghai, Qingdao and other places. The transmission range is wide and the duration is long. Covid-19 antigen detection, as a supplementary means, can strengthen the speed and breadth of epidemic screening, and is expected to effectively alleviate the pressure of nucleic acid detection.
Covid-19 antigen detection aims at the specific needs of people, and the self-test needs and scenes are fully released. The scheme shows that the applicable population for antigen detection mainly includes three types of people: 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 scheme also makes it clear that if community residents have self-test needs, they can purchase antigen detection reagents for self-test through retail pharmacies, online sales platforms and other channels. Referring to overseas prevention and control experience, the United States, the European Union, Australia and other places have strong demand for home self-testing during the period of rapid spread of the epidemic. From the perspective of China, antigen detection is expected to take the lead in promoting in densely populated, mobile and rapidly spreading areas. In terms of price, at present, pharmacies and online sales platforms have launched relevant products, with prices ranging from 14-30 yuan, basically around 20 yuan.
Five products have been approved, and relevant industrial chain enterprises may benefit significantly. 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. Since then, five covid-19 antigen self-test products have been officially listed in China. The barrier of antigen detection itself is not high. In addition to the above five enterprises, many enterprises in China can mass produce antigen detection kits, but previously related products were mainly used for export. According to data from the General Administration of customs, according to data from the General Administration of customs, according to data from the General Administration of customs, in 2021, China has exported a total of 668993 billion yuan of covid-19 detection kits in 2021, and a single month in December 2021 will export more than 10 billion yuan in a single month in December 2021, with more than 10 billion yuan in a single month in December 2021, of which Maccura Biotechnology Co.Ltd(300463) 00463 \ \, and a single month in a single month in December 2021, with more than 10 billion billion billion yuan in a single month in 2021, with a single month of December 2021, 2021, with more than 10 billion billion billion billion billion yuan in a single month of 2021, of which of 2021 December, of which of which includes $100 billion and other companies have obtained the listing qualification of overseas covid-19 antigen reagent. From the perspective of the Chinese market, the current short-term competitive barriers are mainly registration approval and supply capacity. In addition to five listed products, other enterprises that have listed covid-19 antigen detection products overseas are expected to be the first to be approved. At present, China’s relevant quality evaluation standards and registration evaluation methods have not been released, which is expected to be faster than the review time and speed of 1-3 years for the approval of conventional in vitro diagnostic kits.
Investment proposal and investment object
It is expected that the liberalization of covid-19 antigen detection will bring a large marginal increase to the performance of enterprises in relevant industrial chains. It is suggested to pay attention to in vitro diagnostic enterprises whose relevant products have been listed in China or abroad. It is suggested to pay attention to: Guangzhou Wondfo Biotech Co.Ltd(300482) ( Guangzhou Wondfo Biotech Co.Ltd(300482) , not rated), Nanjing Vazyme Biotech Co.Ltd(688105) ( Nanjing Vazyme Biotech Co.Ltd(688105) , not rated), Bgi Genomics Co.Ltd(300676) ( Bgi Genomics Co.Ltd(300676) , not rated), Beijing Hotgen Biotech Co.Ltd(688068) ( Beijing Hotgen Biotech Co.Ltd(688068) , not rated), Zhejiang Orient Gene Biotech Co.Ltd(688298) ( Zhejiang Orient Gene Biotech Co.Ltd(688298) , not rated), Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) ( Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) , not rated), etc.
Risk tips
Changes in prevention and control policies; Increased competition and price decline caused by the listing of relevant competitive products.
