Home self-test covid-19 pneumonia or will it be realized?
In March 11th, the state Wei Jian administration announced that the State Council should have issued the notice on the issuance of the COVID-19 virus antigen detection application plan (Trial Implementation) in response to the joint prevention and control mechanism of New Coronavirus pneumonia in March 10th. It shows that the state will add antigen tests on the basis of nucleic acid detection as a supplement. According to the plan, community residents who need self-test can purchase antigen test reagents for self-test through retail pharmacies, online sales platforms and other channels.
Boosted by the above information, covid-19 pneumonia epidemic detection concept stocks rose in the afternoon on March 11, and GEM stocks Guangzhou Wondfo Biotech Co.Ltd(300482) , Shanghai Labway Clinical Laboratory Co.Ltd(301060) 2 connected to the board. As of the closing, shares such as Andon Health Co.Ltd(002432) , Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) and Zhejiang Orient Gene Biotech Co.Ltd(688298) , Jiangsu Bioperfectus Technologies Co.Ltd(688399) , Beijing Hotgen Biotech Co.Ltd(688068) rose by more than 10%.
which groups are suitable for antigen detection
the scheme stipulates the applicable population 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 plan defines the main conditions to be met by the three groups for antigen detection and the access to detection reagents, and formulates the disposal management process after the detection is found to be positive, so as to promote the connection between antigen detection and nucleic acid detection.
In order to facilitate standardized testing in various regions, the plan also includes two annexes, namely, the basic requirements and procedures for covid-19 virus antigen testing in grass-roots medical and health institutions, and the basic requirements and procedures for covid-19 virus antigen self-testing.
It should be noted that nucleic acid detection is still the basis for the diagnosis of covid-19 virus infection. As a supplementary means, antigen detection can be used for screening of specific populations, which is conducive to improving the ability of "early detection". If the primary medical and health institutions have the ability of nucleic acid detection, nucleic acid detection shall be the first choice; Those who do not have the ability of nucleic acid detection can carry out antigen detection, and do a good job in the training of medical personnel and the communication and guidance of patients. When conducting antigen testing, isolation observers and community residents should carefully read the instructions and standardize the operation. Once the antigen test is positive, they should immediately report to the relevant departments; If necessary, conduct nucleic acid test for confirmation.
According to the analysis of insiders, the introduction of the notice means that China's epidemic prevention and control shows a trend of liberalization. Next, we will be ready to fully meet the normalization of the "post epidemic era". In particular, grass-roots medical institutions will truly become outposts for epidemic prevention and control.
In addition, recently, the Chinese Consulate General in Los Angeles issued a new notice on its official website, according to the latest requirements of Chinese authorities, passengers from the United States to China must increase antigen testing before boarding. Relevant airlines will check the previously required health code and the original report of the new antigen test results before passengers board the plane.
According to the notice, the Chinese Embassy in the United States, the Consulate General in New York, the Consulate General in San Francisco, the Consulate General in Los Angeles and the Consulate General in Chicago will announce the relevant antigen testing arrangements for direct flights to China in their respective consular areas.
test results shall not exceed 30 minutes, and the cost is about 20% of nucleic acid test
Covid-19 detection mainly includes nucleic acid, antibody and antigen.
The reporter learned from many sources that the detection of pathogens can detect both antigens and nucleic acids. Nucleic acid detection has high requirements for laboratory environment, detection personnel and instruments, high detection sensitivity and good specificity. Generally, the results can be obtained in 2 to 3 hours.
Antigen detection is to find the RNA of the virus through nasopharyngeal swab samples.
Comparing the three covid-19 virus detection methods, antigen detection can directly detect the virus infection with low requirements for the laboratory. It can be used for early screening and early diagnosis. The results can be produced within 15 minutes at the fastest. It is suitable for large-scale screening in grass-roots hospitals.
Globally, European and American countries began to use this detection method for a long time, and this detection method also played an important role in Hong Kong, China.
During the two sessions of this year, Huang Ailong, member of the National Committee of the Chinese people's Political Consultative Conference and President of Chongqing Medical University, publicly called for the construction of a normalized epidemic prevention and control model combining "large-scale antigen rapid detection based on home self-test + targeted small-scale accurate nucleic acid detection" as soon as possible.
Huang Ailong believes that compared with nucleic acid detection and antibody detection, rapid antigen detection has many advantages, such as simple operation, fast and efficient, wide application, low cost, safety and reliability, which can greatly reduce the burden of medical staff and medical and health institutions. At the same time, the results of rapid antigen detection shall not exceed 30 minutes, and the reagent cost is about 20% of the nucleic acid detection. If the organization is strong, the screening of large-scale people can be completed in various conferences, sports events and other large-scale activities in a short time. If the two detection methods are combined, it can greatly improve the efficiency of epidemic prevention and control, significantly reduce the cost of epidemic prevention and control, and reduce the restrictions and impact of epidemic prevention and control on economic development.
antigen self test in China may speed up the approval and certification
It is worth mentioning that, according to the government portal of the State Food and drug administration, nmpa has approved a covid-19 antigen detection kit, which is certified by Beijing huaketai Biotechnology Co., Ltd. and the methodology is fluorescence immunochromatography.
this is the fourth covid-19 antigen detection kit approved by China after 15 months. At the same time, this is interpreted by the industry as a huge signal. Some people in the industry told reporters that antigen self-test may speed up the approval of application for certification in China
According to the official data of the State Food and drug administration, the three previously approved products are the products of Guangzhou Wondfo Biotech Co.Ltd(300482) , Beijing jinwofu Bioengineering Technology Co., Ltd. and Bgi Genomics Co.Ltd(300676) Shenzhen Huada Yinyuan Pharmaceutical Technology Co., Ltd.
Source: Anxin securities
Zhongtai Securities Co.Ltd(600918) Research Report indicates that at present, covid-19 antigen self-test kits of hundreds of in vitro diagnostic manufacturers in China have been registered and approved overseas, and the market competition in Europe, Malaysia and other regions is becoming increasingly fierce. Among them, Chinese in vitro testing enterprises represented by Zhejiang Orient Gene Biotech Co.Ltd(688298) , Beijing Hotgen Biotech Co.Ltd(688068) , Andon Health Co.Ltd(002432) , Aikang biology, Sansure Biotech Inc(688289) , Shenzhen Yhlo Biotech Co.Ltd(688575) , etc. have strong demand for overseas orders.
In terms of output, Zhejiang Orient Gene Biotech Co.Ltd(688298) , Aikang biology have previously publicly said that the daily output exceeds 10 million people.
Recently, the performance forecasts released by antigen testing companies mentioned that the company's orders and revenue increased significantly due to the significant increase in overseas demand for covid-19 antigen testing reagents.
Beijing Hotgen Biotech Co.Ltd(688068) it is estimated that the net profit attributable to the parent company will reach 2 billion yuan to 2.35 billion yuan in 2021, with a year-on-year increase of 168465% to 199697% Zhejiang Orient Gene Biotech Co.Ltd(688298) it is estimated that the net profit attributable to the parent company will reach 4.72 billion yuan to 5.12 billion yuan in 2021, with a year-on-year increase of 181.45% to 205.31% Hangzhou Biotest Biotech Co.Ltd(688767) it is estimated that the net profit attributable to the parent company will reach 810 million yuan to 910 million yuan in 2021, with a year-on-year increase of 86.14% to 109.12% Hangzhou Alltest Biotech Co.Ltd(688606) it is estimated that the net profit attributable to the parent company will reach 715 million yuan to 795 million yuan in 2021, with a year-on-year increase of 3.78% to 17.05%.
Relevant enterprise staff told reporters that although there are many manufacturers of covid-19 testing product layout at present, there are not many manufacturers with nmpa and CE certification, and there are great differences in their production capacity. The leading effect is still significant (especially in overseas exports). Manufacturers with excellent product performance and advantageous production capacity are expected to occupy a high market share.
detection concept stocks rise together Guangzhou Wondfo Biotech Co.Ltd(300482) 20cm limit
The voice of antigen detection has aroused great repercussions in the market.
On March 11, covid-19 pneumonia detection concept was raised. Statistics show that on March 11, the wind covid-19 pneumonia detection index increased by more than 8%.
Gao Zhigang
In terms of individual stocks, Guangzhou Wondfo Biotech Co.Ltd(300482) closed at the "20cm" limit Zhejiang Orient Gene Biotech Co.Ltd(688298) also increased by more than 18%, Jiangsu Bioperfectus Technologies Co.Ltd(688399) increased by more than 12%, and Beijing Hotgen Biotech Co.Ltd(688068) increased by more than 11%.
An industry person from a biomedical enterprise told the reporter of Shanghai Securities News that if antigen detection is adopted, it can be understood as an effective supplement to the current nucleic acid detection. For those who are antibody positive (according to the current single detection of antibody, positive people need to be isolated) but antigen negative people, there is no need to be isolated. This is a more precise prevention and control of the existing policies.
"If antigen testing can be popularized, for the market, it means that companies doing antigen testing will have more market demand." A person in the securities industry told reporters.
Tianfeng Securities Co.Ltd(601162) believes that China's antigen detection has the advantages of mature products, sufficient production capacity supply and rapid response to antigen detection in specific application scenarios, which is expected to become an important supplementary means to improve the normalization prevention and control and emergency response mechanism for sudden outbreaks.
promote the delivery of covid-19 pneumonia treatment drugs
At the same time, a piece of information from Pfizer also gave the market a new understanding of precise prevention and control.
On March 9, Pfizer and general technology China Meheco Group Co.Ltd(600056) (hereinafter referred to as "general technology China Meheco Group Co.Ltd(600056) ") jointly announced the signing of a supply agreement on the combined packaging of nevitavir tablets / ritonavir tablets (paxlovid) for covid-19 pneumonia virus treatment. General technology China Meheco Group Co.Ltd(600056) will be responsible for the commercial operation of Pfizer Inc COVID-19 virus treatment PAXLOVID in Chinese mainland market during the agreement period.
Previously, the State Drug Administration conducted emergency review and approval in accordance with the relevant provisions of the drug administration law and the special drug approval procedures, and conditionally approved the import registration of Pfizer covid-19 pneumonia virus treatment drug paxlovid.
PAXLOVID is an oral small molecule COVID-19 pneumonia virus therapeutic agent for the treatment of mild to moderate New Coronavirus pneumonia (COVID-19) in adults with severe risk factors, such as elderly, chronic kidney disease, diabetes, cardiovascular disease, and chronic pulmonary disease.
"It is a great honor for us to cooperate with general technology China Meheco Group Co.Ltd(600056) to support the Chinese government and people in actively coping with this public health crisis." Peng Zhenke, President of Pfizer biopharmaceutical group in China, said, "Pfizer will firmly support China to deal with the current and possible medical and health challenges in the future, and help realize the grand vision of 'Healthy China 2030'."
Li Yadong, assistant general manager of general technology group, chairman of general technology China Meheco Group Co.Ltd(600056) and Secretary of the Party committee, said: "in this cooperation, the two sides will rely on their resource advantages to fully promote the implementation of covid-19 pneumonia treatment drugs, so that Chinese patients can share the original research results with the international community."
