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The State Food and Drug Administration issued a notice on March 12 to approve the application change of the application application for the detection of new crown antigen products in Nanjing Nuoweizan, Beijing Jinwolf, Shenzhen Huada Inyuan, Guangzhou Wanfu Biology and Beijing Huaketai Biology. This also means that five new crown antigen testing products are officially launched.
In the context of the emergence of the new crown epidemic in many places in China, the listing of related products has also aroused great concern in the market. On the evening of March 13, BGI, Novozam, Wanfu Bio and other listed companies disclosed that their new crown antigen testing products had completed the intended use of medical device product registration, increased the sample type and the content of the instructions. Mingde Bio said that the company's new crown antigen detection reagent has submitted a registration application to the State Drug Administration.
A number of companies have launched new crown antigen testing products
According to the announcement of BGI Gene (300676), the holding subsidiary BGI Inyuan recently obtained the "Document for The Change of Medical Device Registration of the People's Republic of China (In Vitro Diagnostic Reagent)" issued by the State Food and Drug Administration, and changed the medical device registration certificate of the new crown antigen testing product.
"Antigen detection is a test that directly targets the unique protein (i.e., antigen) in the virus, can quickly detect positive cases during the acute infection period, and can be used as a supplementary test for screening specific populations, which is conducive to improving the ability of 'early detection' and plays an important role in optimizing the detection strategy of the new crown virus and the overall epidemic prevention and control." BGI said that the change of the medical device registration certificate has increased the scope of application of BGI's new crown antigen testing products, which will help meet the diversified testing scenarios of the overall epidemic prevention and control, and help improve the company's comprehensive competitiveness.
The novel coronavirus antigen detection kit produced by Novizam Medical, a wholly-owned subsidiary of 688105, has completed the changes to the intended use of medical device product registration, the increase in sample type and the content of the instructions. The company stressed that the above changes further respond to the national COVID-19 epidemic prevention and control and testing policy, which will help further enhance the company's competitiveness in related fields.
Wanfu Bio (300482) also emphasizes that antigen detection is conducive to improving the "early detection" ability. Mingde Biotechnology (002932) said in the stock price change announcement 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) said on the interactive platform that the company's self-testing agent for the new crown antigen detection has successively obtained the EU CE, German BfArM and other registration certificates, and will be actively sold to Europe, Southeast Asia and other registration certificates recognized by the region, and actively apply for registration certification in other overseas countries to expand the scope of sales, the company will actively expand domestic and foreign channels to help prevent and control the epidemic.
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 the commercial development, registration and sales of "household novel coronavirus antigen detection reagent". After signing the contract, the two sides will quickly complete the verification of real samples for clinical sample resources and testing resources, complete the clinical research of antigen kits, and work with Hanyu Pharmaceutical to develop products with better sensitivity and specificity to solve the common problems such as missed tests and false positives that still exist in antigen detection, and further improve the ability of "early detection".
The research report recommends paying attention to investment opportunities in the whole industry chain
On the evening of March 11, the National Health Commission released the news that after research, the Comprehensive Group of the Joint Prevention and Control Mechanism of the State Council in Response to the Novel Coronavirus Pneumonia Epidemic decided to add antigen detection as a supplement to nucleic acid testing, and organized the formulation of the "Application Plan for New Coronavirus Antigen Detection (Trial)".
The "Plan" stipulates the applicable groups for antigen testing: first, those who go to primary medical and health institutions for treatment, accompanied by respiratory tract, fever and other symptoms and have symptoms within 5 days; second, isolation and observation personnel, including home isolation observation, close contact and sub-close connection, entry isolation observation, sealing and control area and control area; third, community residents with antigen self-testing needs. At the same time, the main conditions to be met for antigen detection in the three types of people and the channels for obtaining detection reagents are clarified, and the disposal management process after the test is found to be positive is formulated to promote the connection between antigen detection and nucleic acid detection.
Huaan Securities Research Report believes that the introduction of the "Application Plan for The Detection of New Coronavirus Antigens (Trial)" means that the domestic antigen detection market has been opened, and the upstream, middle and lower reaches will be expanded rapidly. It is recommended to pay attention to the investment opportunities of the whole industry chain, and the relevant beneficiary listed companies are as follows:
Upstream raw materials
Antigen antibody reagents: Novizan, Yiqiao Shenzhou, Baipusaisi, Youningwei, Fei peng biological (to be listed), etc.;
Excipients: Gongdong Medical, Egg Biological, Changhong Technology, Yangpu Medical, etc.;
Packaging materials: Haishun new materials, global printing, Kerui technology, etc.;
Midstream manufacturing
Approved in China: Wanfu Bio, Nuowei Zan, BGI Gene;
Overseas approvals: Jiuan Medical, Oriental Biologics, Mingde Biology, Heatscape Biology, Botuo Biology, Yahuilong, Anxu Biologics, etc.;
Downstream terminal sales
Retail pharmacies: ordinary people, Yifeng Pharmacy, Dashenlin, Yixintang, Chinese medicine consistency, JianZhijia, Shuyu civilians, etc.;
Pharmaceutical e-commerce: JD Health, Ali Health, Ping An Good Doctor, Kefu Medical, Yuyue Medical, etc.
Zhongtai Securities Research Report estimates that the domestic new crown antigen self-test kit market is expected to reach 17.7-266 billion yuan in a single month. Considering the continuous recurrence of the epidemic and the need for subsequent national liberalization, it is recommended to continue to attach importance to investment opportunities in the new crown-related industrial chain and pay attention to two main lines:
1) Testing, such as Wanfu Biological, Novizon, Jiuqiang Biological, Mingde Biological, Jiuan Medical, Dongfang Biological, Yahuilong, Heatscape Biology, Anxu Biology and other IVD test targets, as well as related reagents and consumables upstream targets such as Yiqiao Shenzhou, Baipusaisi, Gongdong Medical, Changhong Technology, etc.; In addition, considering the increase in self-inspection demand, Yifeng Pharmacy, Ordinary People, Dashanlin, Yixintang and other retail pharmacies are expected to continue to benefit;
2) Oral drugs: the United States has OUA Pfizer (PAXLOVID) and Merck (Molnupiravir) two small molecule oral drugs; domestic real organisms of Azivudine Phase III clinical, a number of early clinical stage small molecule drugs in research, Junshi Bio VV116 overseas has been approved, Frontier Biologics US Phase I clinical is underway. Focus on the domestic R&D and innovation enterprises with high progress, the CDMO industry chain of innovative drugs of overseas large pharmaceutical companies and the industrial chain of generic drugs, such as Junshi Bio, WuXi AppTec, GloriaIn, Boteng Shares, Jiuzhou Pharmaceutical, Puluo Pharmaceutical, Tianyu Shares, Aoxiang Pharmaceutical, Aurierite, Menova, etc.