The first batch of “self-test version” covid-19 antigen detection kits are here.
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 self-test products of vid-19 antigen have been officially launched.
01, the first five approved
In March 11th, the national health and Health Committee announced that after the study, the State Council responded to the comprehensive prevention and control mechanism of New Coronavirus pneumonia, and decided to add antigen detection on the basis of nucleic acid detection, and formulated the “COVID-19 virus antigen detection application plan (Trial Implementation)”.
The scheme stipulates the applicable groups for antigen detection: 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 main conditions to be met for antigen detection of the three groups and the access to detection reagents were clarified, and the disposal management process after positive detection was formulated to promote the connection between antigen detection and nucleic acid detection.
Just one day later, five covid-19 antigen self-test products were officially launched.
According to the information to be received for the approval document (change) of medical devices released on the website of the State Food and Drug Administration on March 12, it was issued by Guangzhou Wondfo Biotech Co.Ltd(300482) , Bgi Genomics Co.Ltd(300676) subsidiary Shenzhen Huada Yinyuan Pharmaceutical Technology Co., Ltd., Beijing jinwofu Bioengineering Technology Co., Ltd., Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) Medical Technology Co., Ltd Five covid-19 antigen detection kits developed by five companies of Beijing huaketai Biotechnology Co., Ltd. have passed the registration information change of the food and drug administration.
professionals learned that the core of the “registration change” is that the test reagent is no longer limited to “only used by professional technicians”. This means that relevant detection reagents will be used in other scenarios such as home self-test
Five covid-19 antigen detection kits belong to five companies, of which Guangzhou Wondfo Biotech Co.Ltd(300482) , Shenzhen Huada Yinyuan ( Bgi Genomics Co.Ltd(300676) ), Nanjing Vazyme Biotech Co.Ltd(688105) are A-share companies, while Beijing jinwofu and Beijing huaketai biology have not yet landed in the capital market it is worth noting that Beijing huaketai biology disclosed the gem IPO prospectus in 2019, but finally withdrew its application
02, self test conditions
In fact, many of the five covid-19 antigen detection kit products of the five companies newly approved for listing have been approved in 2020, but they all belong to the professional version before changing the registration information and need to be operated by professionals.
Specifically, in November 2020, New Coronavirus’s (2019-nCoV) antigen detection kit (colloidal gold method) and the New Coronavirus (2019-nCoV) antigen detection kit (latex method) of Guangzhou Wondfo Biotech Co.Ltd(300482) were obtained by the State Administration of drug supervision and approval, and became the first batch of products that China obtained the registration certificate of medical devices in Beijing. In the following month, the New Coronavirus antigen detection kit developed by Shenzhen Huada was also registered with the medical device.
At the beginning of March 2022, the New Coronavirus (2019-nCoV) antigen detection kit (fluorescence immunochromatography) was approved for sale, and it soon had the capacity of large-scale supply.
On the day of the release of the plan, Nanjing Vazyme Biotech Co.Ltd(688105) medical announced that the new coronavirus antigen detection kit independently developed and produced by the wholly-owned subsidiary Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) Medical Technology Co., Ltd. recently received the medical device registration certificate issued by the State Food and drug administration.
Nanjing Vazyme Biotech Co.Ltd(688105) indicated that the kit could be used to detect New Coronavirus N antigen and S antigen in oral and throat swabs and nasopharyngeal swabs samples from suspected infected people of New Coronavirus. The above products are generally used in acute infection period, that is, sample detection within 7 days of symptoms of suspected people. It can be used as an auxiliary and supplement for nucleic acid detection, and further improve the ability of early detection with the national New Coronavirus detection strategy. also reminded that the kit should not be used solely for the diagnosis of New Coronavirus infection.
So far, there are five kits in China’s covid-19 antigen detection market. The technical path covers colloidal gold, latex, fluorescence immunochromatography and other types with relatively simple requirements for instrument environment and operation, which provides an accessible choice for the personnel who go to grass-roots medical and health institutions to carry out covid-19 antigen rapid detection in the plan.
from the approval conditions, the above five covid-19 antigen detection products are professional versions according to the operation procedure of primary medical institutions, the use of this professional version of covid-19 antigen detection kit requires sampling personnel who have passed the biosafety training and are familiar with the relevant requirements, and testing personnel with relevant qualifications to complete it under the support of specific environment and instruments and equipment, and cannot be used for home self-test.
On March 12, the State Food and Drug Administration issued the pending information of the medical device approval document (change), and the five covid-19 antigen detection kits developed by the above five companies passed the registration information change of the State Food and drug administration professionals learned that the core of the “registration change” is that the test reagent is no longer limited to “only used by professional technicians” this means that the “test reagent after registration change is no longer limited” is only used by professional technicians, and its scope of use is further expanded. It has the qualification to sell in retail pharmacies and online sales platforms.
03, existing overseas orders
In addition to the first five enterprises mentioned above, many enterprises in China have been able to mass produce antigen detection kits, but previously related products were mainly used for export.
According to the General Administration of customs, China exported covid-19 test kits worth 66.893 billion yuan overseas in 2021, and the national covid-19 reagent export exceeded 10 billion yuan in a single month in December 2021 Maccura Biotechnology Co.Ltd(300463) , Bgi Genomics Co.Ltd(300676) , Dian Diagnostics Group Co.Ltd(300244) , Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) and other companies have obtained the listing qualification of overseas covid-19 antigen detection reagent.
In addition, companies in China that have obtained the emergency use authorization of FDA EUA include Andon Health Co.Ltd(002432) , Zhejiang Orient Gene Biotech Co.Ltd(688298) and Aikang biology. On January 14 this year, Andon Health Co.Ltd(002432) announced that it had signed a purchase contract with American ACC for 250 million copies of ihealth covid-19 antigen home self-test OTC kit products Zhejiang Orient Gene Biotech Co.Ltd(688298) 2021 semi annual report shows that in the first half of 2021, the export revenue of covid-19 detection reagent (mainly antigen) of the company was 6.188 billion yuan, accounting for about 13.78% of the total export revenue of covid-19 reagent in China.
The 2020 China in vitro diagnostic industry report released at the 8th China in vitro diagnostic industry development conference shows that the development trend in the next five years will be that the amount of routine detection will decrease in at least two years, the income of nucleic acid detection related to covid-19 will increase significantly, the amount of antibody detection will fluctuate, and the demand for rapid antigen detection will increase, Covid-19 testing business may continue until 2024.
