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. This also means that five covid-19 antigen detection products are officially on the market.
in the context of covid-19 epidemic 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) , Nanjing Vazyme Biotech Co.Ltd(688105) , Guangzhou Wondfo Biotech Co.Ltd(300482) and other listed companies disclosed announcements, indicating that their covid-19 antigen detection products have completed the changes in the intended use of medical device product registration, increased sample types and instructions 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
several companies listed covid-19 antigen detection products
Bgi Genomics Co.Ltd(300676) ( Bgi Genomics Co.Ltd(300676) ) announcement shows that the holding subsidiary Huada Yinyuan recently obtained the medical device registration change document 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 testing 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.
Nanjing Vazyme Biotech Co.Ltd(688105) ( Nanjing Vazyme Biotech Co.Ltd(688105) ) wholly owned subsidiary Nanjing Vazyme Biotech Co.Ltd(688105) medical production New Coronavirus antigen detection kit completed the expected use of medical device product registration, increased the sample type and 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) ( 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) ( Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) ) said in the announcement of share price change 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 registration certificates such as EU CE and Germany bfarm, and will be actively sold to regions recognized by registration certificates such as Europe and Southeast Asia, and actively apply for registration 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, the third people's Hospital of Shenzhen and the Hybio Pharmaceutical Co.Ltd(300199) ( Hybio Pharmaceutical Co.Ltd(300199) ) signed the binding letter of intent, 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".
research report suggests paying attention to investment opportunities in the whole industry chain
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 (for Trial Implementation) 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. The relevant beneficiary listed companies are as follows:
upstream raw materials
Antigen antibody reagents: Nanjing Vazyme Biotech Co.Ltd(688105) , Sino Biological Inc(301047) , Acrobiosystems Co.Ltd(301080) , youningwei, Feipeng Biology (to be listed), etc;
Auxiliary materials: Zhejiang Gongdong Medical Technology Co.Ltd(605369) , Getein Biotech Inc(603387) , Shenzhen Changhong Technology Co.Ltd(300151) , Guangzhou Improve Medical Instruments Co.Ltd(300030) , etc;
Packaging materials: Shanghai Haishun New Pharmaceutical Packaging Co.Ltd(300501) , Xi'An Global Printing Co.Ltd(002799) , Shenzhen Colibri Technologies Co.Ltd(002957) , etc;
midstream manufacturing
China has been approved: Guangzhou Wondfo Biotech Co.Ltd(300482) , Nanjing Vazyme Biotech Co.Ltd(688105) , Bgi Genomics Co.Ltd(300676) ;
Overseas approved: Andon Health Co.Ltd(002432) , Zhejiang Orient Gene Biotech Co.Ltd(688298) , Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) , Beijing Hotgen Biotech Co.Ltd(688068) , Hangzhou Biotest Biotech Co.Ltd(688767) , Shenzhen Yhlo Biotech Co.Ltd(688575) , an Xu biology, etc;
downstream terminal sales
Retail pharmacies: Lbx Pharmacy Chain Joint Stock Company(603883) , Yifeng Pharmacy Chain Co.Ltd(603939) , Dashenlin Pharmaceutical Group Co.Ltd(603233) , Yixintang Pharmaceutical Group Co.Ltd(002727) , China National Accord Medicines Corporation Ltd(000028) , Yunnan Jianzhijia Health-Chain Co.Ltd(605266) , Shuyu Civilian Pharmacy Corp.Ltd(301017) , etc;
Pharmaceutical e-commerce: JD health, Alibaba health, Ping an good doctor, Cofoe Medical Technology Co.Ltd(301087) , Jiangsu Yuyue Medical Equipment And Supply Co.Ltd(002223) , etc.
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 17.7-26.6 billion yuan per month. Considering the continuous recurrence of the epidemic and the subsequent demand for opening up the country, it is suggested to continue to pay attention to investment opportunities in covid-19 related industrial chains and pay attention to two main lines:
1) detection, such as: detection, such as Guangzhou Wondfo Biotech Co.Ltd(300482) cursor, such as Sino Biological Inc(301047) , Acrobiosystems Co.Ltd(301080) , Zhejiang Gongdong Medical Technology Co.Ltd(605369) , Shenzhen Changhong Technology Co.Ltd(300151) , etc; In addition, considering the increased demand for self inspection, Yifeng Pharmacy Chain Co.Ltd(603939) , Lbx Pharmacy Chain Joint Stock Company(603883) , Dashenlin Pharmaceutical Group Co.Ltd(603233) , Yixintang Pharmaceutical Group Co.Ltd(002727) and other retail pharmacies are expected to continue to benefit;
2) oral drugs: the United States has two small molecule oral drugs: EUA Pfizer (paxlovid) and molnupiravir; Chinese real biological azvudine is in phase III clinic, and a variety of small molecule drugs in early clinical stage are under research, Shanghai Junshi Biosciences Co.Ltd(688180) vv116 has been approved overseas, and Frontier Biotechnologies Inc(688221) American phase I clinic is in progress. Focusing on the Chinese R & D and innovation enterprises, the Chinese R & D and innovation enterprises, the cdmo industry chain for new drugs created by big overseas drug companies, and the generic industry chain and the generic industry chain that focus on the Chinese R & D and innovation companies, the Chinese R & D and innovation enterprises, the big overseas drug companies, the cdmo industry chain for new drugs and the Chinese R & D and innovation enterprises, the big overseas drug companies, the cdmo industry chain for new drug cdmo industry chain and the generic industry chain, such as Beijing Abt Networks Co.Ltd(688168) 81 Shanghai Junshi Biosciences Co.Ltd(688180) , Aurisco Pharmaceutical Co.Ltd(605116) , Ningbo Menovo Pharmaceutical Co.Ltd(603538) , etc.
