Securities Times reporter Zang Xiaosong

　　The State Food and Drug Administration issued a notice on March 12, approving the application changes for the detection and application of new crown antigen products of Nanjing Novizan, Beijing Jinwofu, Shenzhen Huada Yinyuan, Guangzhou Wanfu Bio, and Beijing Huaketai Bio.

　　In the context of the new crown pneumonia epidemic in many places in China, the launch of related products has also aroused high market attention.

On the evening of March 13, listed companies such as BGI (300676), Novozyme (688105), and Wanfu Bio (300482) announced that their new crown antigen detection products have completed the intended use of medical device product registration, increased sample types and Changes to the contents of the manual.

Mingde Bio (002932) stated that the company's new crown antigen detection reagent has submitted a registration application to the State Drug Administration.

　　Multiple company announcements

　　Antigen Detection Products

　　According to the announcement of BGI, the holding subsidiary BGI Yinyuan has recently obtained the "People's Republic of China Medical Device Registration Change Document (In Vitro Diagnostic Reagent)" issued by the State Food and Drug Administration, and has changed the medical device registration certificate of the new crown antigen detection product. .

　　"Antigen detection is a direct detection of the unique protein (ie antigen) in the virus, which can quickly detect positive cases in the acute infection period, and can be used as a supplementary detection method for screening of specific populations, which is conducive to improving the ability of 'early detection', It plays an important role in optimizing the new crown virus detection strategy and the overall epidemic prevention and control." BGI said that the change of the medical device registration certificate has increased the application scope of BGI's new crown antigen detection products, which will help meet the overall epidemic prevention and control requirements. The diversified detection scenarios of control are conducive to improving the comprehensive competitiveness of the company.

　　The novel coronavirus antigen detection kit produced by Novozymes, a wholly-owned subsidiary of Novozymes, has completed the intended use of medical device product registration, added sample types and changed the contents of the instructions.

The company emphasized that the above changes further respond to the national new crown epidemic prevention and testing policy, which will help to further enhance the company's competitiveness in related fields.

　　Wanfu Bio also emphasizes that antigen detection is conducive to improving the ability of "early detection".

In the stock price change announcement, Mingde Bio stated that the company's new crown antigen detection reagent has submitted a registration application to the State Drug Administration, and the time for obtaining the registration certificate is still uncertain.

　　In addition, Lepu Medical (300003) stated on the interactive platform that the company’s self-developed new crown antigen detection self-test reagent has successively obtained the EU CE, the German Federal Agency for Drugs and Medical Devices (BfArM) and other registration certificates, and will be actively sold in Europe, Southeast Asia and other regions recognized by the registration certificate, and actively apply for registration certification in other overseas countries to expand the sales scope, the company will actively expand domestic and foreign channels to help epidemic prevention and control.

　　Previously on March 11, Shenzhen National Clinical Research Center for Infectious Diseases, Shenzhen Third People's Hospital and Hanyu Pharmaceutical (300199) signed a binding letter of intent to exclusively authorize Hanyu Pharmaceutical to carry out "home-use novel coronavirus antigens". Detection Reagents" commercial development, registration and sales.

After the signing of the contract, the two parties will quickly complete the verification of real samples for clinical sample resources and detection resources, complete the clinical research of antigen kits, and cooperate with Hanyu Pharmaceutical to develop products with better sensitivity and specificity to solve the current problems in antigen detection. There are common problems such as missed detection and false positives, which further improves the ability of "early detection".

　　Antigen testing market attracts attention

　　On the evening of March 11, the National Health and Medical Commission announced that after research, the State Council's comprehensive team of the joint prevention and control mechanism for the new coronavirus pneumonia epidemic decided to add antigen testing as a supplement on the basis of nucleic acid testing, and organized the formulation of the "New Coronavirus Antigens". Detection Application Scheme (Trial)".

　　The "Plan" stipulates the applicable population of antigen testing: first, those who go to primary medical and health institutions for treatment, with symptoms such as respiratory tract and fever, and have symptoms within 5 days; Personnel in close contact, entry quarantine observation, closed and controlled areas, and control areas; the third is community residents who need antigen self-testing.

At the same time, the main conditions that need to be met for antigen testing for three groups of people and the channels for obtaining testing reagents have been clarified, and the disposal management process after positive testing has been formulated to promote the connection between antigen testing and nucleic acid testing.

Huaan Securities Research Report believes that the introduction of the "New Coronavirus Antigen Detection Application Plan (Trial)" means that the domestic antigen detection market has been opened, and the upstream, midstream and downstream will be rapidly expanded. It is recommended to pay attention to investment opportunities in the entire industry chain.

　　According to the research report of Zhongtai Securities, the monthly scale of the domestic new crown antigen self-test kit market is expected to reach 17.7 billion to 26.6 billion yuan.

Considering the continued recurrence of the epidemic and the need for subsequent liberalization of the country, it is recommended to continue to pay attention to investment opportunities in the new crown-related industry chain.