The State Food and Drug Administration issued a notice on March 12, approving the change of covid-19 antigen product detection application of Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) , Beijing jinwofu, Shenzhen Huada Yinyuan, Guangzhou Guangzhou Wondfo Biotech Co.Ltd(300482) , Beijing huaketai biology.
Under the background of covid-19 pneumonia in many places in China, the listing of relevant products has also aroused great concern in the market. On March 13, Bgi Genomics Co.Ltd(300676) ( Bgi Genomics Co.Ltd(300676) ), Nanjing Vazyme Biotech Co.Ltd(688105) ( Nanjing Vazyme Biotech Co.Ltd(688105) ), Guangzhou Wondfo Biotech Co.Ltd(300482) ( Guangzhou Wondfo Biotech Co.Ltd(300482) ) and other listed companies announced that their covid-19 antigen detection products had completed the changes in the intended use of medical device product registration, added sample types and instructions Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) ( Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) ) said that the company's covid-19 antigen detection reagent had submitted an application for registration to the State Drug Administration.
announcement of companies
antigen detection products
Bgi Genomics Co.Ltd(300676) announcement shows that Huada Yinyuan, a holding subsidiary, recently obtained the document of medical device registration change of the people's Republic of China (in vitro diagnostic reagent) issued by the State Food and drug administration to change the medical device registration certificate of covid-19 antigen detection products.
"Antigen detection is to directly detect the specific protein (i.e. antigen) in the virus, which can quickly detect positive cases in the acute infection period. It can be used as a supplementary detection method for screening specific populations, which is conducive to improving the ability of 'early detection', and plays an important role in optimizing covid-19 virus detection strategy and overall epidemic prevention and control." Bgi Genomics Co.Ltd(300676) said that the change of medical device registration certificate increases the scope of application of covid-19 antigen detection products of Huada Yinyuan, helps to meet the diversified detection scenarios of overall epidemic prevention and control, and helps to improve the comprehensive competitiveness of the company.
The New Coronavirus antigen detection kit produced by Nanjing Vazyme Biotech Co.Ltd(688105) , a wholly owned subsidiary of Nanjing Vazyme Biotech Co.Ltd(688105) , has completed the intended use of medical device product registration, increased the sample type and the changes in the content of the instructions. The company stressed that the above changes further responded to the national covid-19 epidemic prevention and detection policy and helped to further enhance the company's competitiveness in relevant fields.
Guangzhou Wondfo Biotech Co.Ltd(300482) also emphasizes that antigen detection is conducive to improving the ability of "early detection" Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) said in the announcement of share price changes that the company's covid-19 antigen detection reagent has submitted an application for registration to the State Drug Administration, and the acquisition time of the registration certificate is still uncertain.
In addition, Lepu Medical Technology (Beijing) Co.Ltd(300003) ( Lepu Medical Technology (Beijing) Co.Ltd(300003) ) said on the interactive platform that the covid-19 antigen detection self-test reagent independently developed by the company has successively obtained the registration certificates of EU CE and German federal agency for drugs and medical devices (bfarm), and will be actively sold to regions recognized by registration certificates such as Europe and Southeast Asia, and actively apply for registration and certification from other overseas countries to expand the scope of sales, The company will actively expand channels outside China to help with epidemic prevention and control.
In March 11th, the Shenzhen national infectious disease clinical medical research center and the third people's Hospital of Shenzhen signed a binding letter of intent with Hybio Pharmaceutical Co.Ltd(300199) ( Hybio Pharmaceutical Co.Ltd(300199) ), which authorized Hybio Pharmaceutical Co.Ltd(300199) to carry out the commercial development, registration and sale of "household New Coronavirus antigen detection reagent". After signing the contract, both parties will quickly complete the verification of real samples for clinical sample resources and testing resources, complete the clinical research of antigen kit, and cooperate with Hybio Pharmaceutical Co.Ltd(300199) to develop products with better sensitivity and specificity, so as to solve the common problems such as missed detection and false positive in antigen detection, and further improve the ability of "early detection".
antigen detection market attracts attention
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 Huaan Securities Co.Ltd(600909) research report believes that the introduction of covid-19 virus antigen detection application scheme (Trial) means that China's antigen detection market will be opened and the upstream, middle and downstream will be rapidly expanded. It is suggested to pay attention to the investment opportunities of the whole industrial chain.
Zhongtai Securities Co.Ltd(600918) research report predicts that the market scale of covid-19 antigen self-test kit in China is expected to reach 17.7 billion ~ 26.6 billion yuan per month. Considering the continuous recurrence of the epidemic and the demand for subsequent opening up of the country, it is suggested to continue to pay attention to investment opportunities in covid-19 related industrial chains.
