Review report of pharmaceutical and biological industry: covid-19 virus antigen detection application scheme was officially released, and the detection theme is in the ascendant

In March 11, 2022, the State Council issued the "COVID-19 virus antigen detection application plan" (Trial Implementation) to the comprehensive group of New Coronavirus pneumonia epidemic prevention and control mechanism, and added antigen detection as a supplement on the basis of nucleic acid detection.

Open covid-19 antigen self-test, retail pharmacies and online sales platforms

The plan specifies that the applicable groups for antigen testing include:

(1) those who go to grass-roots medical and health institutions with respiratory tract, fever and other symptoms within 5 days. The antigen detection reagents provided by grass-roots medical and health institutions are included in the centralized bidding procurement, which can continuously reduce the price of detection reagents and reduce the burden of detection costs through provincial centralized bidding and procurement.

(2) isolation and observation personnel, including personnel in home isolation and observation, close connection and secondary close connection, entry isolation and observation, sealing and control area and control area. The administrative department organizing isolation observation (such as communities, villages and towns, isolation points, etc.) is responsible for the procurement, distribution, management and other related work of antigen detection reagents.

(3) community residents with antigen self-test needs. Community residents who need self-test can purchase antigen test reagents for self-test through retail pharmacies, online sales platforms and other channels.

Antigen self-test as a supplement, nucleic acid test is still the basis for diagnosis

At present, covid-19 virus detection in the world is mainly divided into three methods: (1) nucleic acid detection based on molecular level: the main detection method in China, which is also one of the diagnostic criteria of covid-19 pneumonia; However, the requirements for development conditions are high (including environment, personnel, etc.) and the detection time is long. (2) Antibody detection based on immunology: it is easy and fast to operate, but the detection window is late. (3) Antigen detection based on immunology: it is divided into professional version and self-test version. The self-test version can be used in home environment and has significant advantages in convenience; But the accuracy is relatively low.

According to the protocol, nucleic acid detection is still the basis for the diagnosis of covid-19 virus infection. In the process of nucleic acid test confirmation, if the nucleic acid test is positive, no matter whether the antigen test result is positive or negative, corresponding measures shall be taken according to covid-19 virus infected patients or covid-19 pneumonia diagnosed patients; If the nucleic acid test is negative but the antigen test is positive, it shall be regarded as covid-19 virus infected, take centralized isolation and other measures, closely observe and continuously carry out nucleic acid test.

Five self-test products were officially launched, and the market scale reached 10 billion in a single month

On March 12, the government affairs service portal of the State Drug Administration showed that Nanjing Vazyme Biotech Co.Ltd(688105) (colloidal gold method), jinwofu (latex method), huadayin (fluorescence immunochromatography), Guangzhou Wondfo Biotech Co.Ltd(300482) (colloidal gold method) and huaketai (fluorescence immunochromatography) had passed the change of approval documents, which were only used by professionally trained personnel, The change shall be implemented with reference to the application scheme for covid-19 virus antigen detection (Trial Implementation) and other relevant national regulations. The first batch of covid-19 antigen self-test kit products were officially launched. From the perspective of methodology, the kit based on fluorescence immunochromatography needs to be adapted to the dry fluorescence immunoanalyzer, while the kit based on colloidal gold method may be more widely used.

Germany provides free antigen testing services at most once a day at the peak of the epidemic. Some other overseas countries distribute antigen self-test products about 2-10 times a month. The ex factory unit price of Chinese manufacturers is US $0.7-2. According to the detection frequency of 1-2 times per capita per month in the peak period, the ex factory unit price is 8-12 yuan and the total population of 1.4 billion, the market scale of antigen self-test in China in a single month reaches 11.2-33.6 billion yuan.

Recommended targets: Guangzhou Wondfo Biotech Co.Ltd(300482) , Nanjing Vazyme Biotech Co.Ltd(688105) , Sino Biological Inc(301047) , Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) .

Other related businesses: (1) the covid-19 self-test kit for viral antigen antigen self-test Kit: (1) the covid-19 is related to other related businesses: (1) the self-test kit for viral antigen from the virus antigen from the virus antigen: (1) the self-test kit kit for the virus antigen from the virus antigen from the avid: (1) the covidvidvidvidvidvidvidvidvidvidvidvidvidvidvidvidvidvidvidvidvidvidvidvidvidvidvidvid: (1) from: (1) the self-test kit kit kit for the virus antigen from the vidvidvidvid: (1: (1) the self-test kit kit kit for the virus antigen from the vidvidvidvidvidvidvidvidvidvid: (1) a Guangdong Huate Gas Co.Ltd(688268) 82828298 Jiangsu Bioperfectus Technologies Co.Ltd(688399) , Lepu Medical Technology (Beijing) Co.Ltd(300003) , Getein Biotech Inc(603387) , Maccura Biotechnology Co.Ltd(300463) , Hybio Pharmaceutical Co.Ltd(300199) ; (2) Upstream raw materials: Acrobiosystems Co.Ltd(301080) , Feipeng Biology (under IPO application), nearshore protein (under IPO application); (3) Online channels: Jiangsu Yuyue Medical Equipment And Supply Co.Ltd(002223) , Cofoe Medical Technology Co.Ltd(301087) ; (4) Retail pharmacies: Dashenlin Pharmaceutical Group Co.Ltd(603233) , Lbx Pharmacy Chain Joint Stock Company(603883) , Yixintang Pharmaceutical Group Co.Ltd(002727) , Yifeng Pharmacy Chain Co.Ltd(603939) .

Risk warning: policy risk, risk of sales not meeting expectations, risk of price decline.

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