According to the official website of the State Food and drug administration, on March 18, the State Food and Drug Administration approved three covid-19 virus antigen detection reagent products. Up to now, the State Food and drug administration has approved 17 covid-19 virus antigen detection reagent products.
100 billion market or expected
It is reported that in March 11th, the national health and Health Committee issued the notice on the issuance of the COVID-19 virus antigen detection application plan (Trial Implementation). In response to the comprehensive prevention and control mechanism of New Coronavirus pneumonia, the integrated group decided to increase the antigen detection on the basis of nucleic acid detection, and formulated the “COVID-19 virus antigen detection application plan (Trial Implementation)” (hereinafter referred to as the “plan”).
According to the official display, as of now, the official official show, the national food regulatory administration has successively approved the following official shows, as of now, the official official official shows that the National Drug Administration has so far, with the official official official official official official official shows that, as of now, the country’s official display, the National Drug Administration has so far, the country’s FDA has successively approved the following approvals in succession, as of now, the National Drug Administration has so far, the National Drug Administration has so far, the National Drug Administration has so far, and the National Drug Administration has so far, the country’s FDA has successively approved the following of the life of the huakettag, the 68810 Nanjing Vazyme Biotech Co.Ltd(688105) applicationfor registration of 17 covid-19 antigen / antibody detection kit products.
After the implementation of the policy, many institutions predict the demand for antigen detection reagents in China Zheshang Securities Co.Ltd(601878) believes that only considering the three scenarios in the plan, with the implementation of follow-up policies, the following market space is expected to be opened later. Under the neutral assumption, the market space detected each year is about 62 billion yuan, and the market space of reagents is about 38 billion yuan, with a total potential market space of nearly 100 billion yuan.
However, as for whether it can replace nucleic acid detection, Wu Jinglei, director of Shanghai Municipal Health Commission, also said at today’s press conference that covid-19 antigen detection is mainly used for rapid population screening and diversion management, so as to shorten the transmission chain. The advantages are fast, simple and easy. The disadvantage is that the sensitivity is not as good as nucleic acid detection, and missed diagnosis may occur. At present, antigen detection is a supplementary means of covid-19 pneumonia detection. Nucleic acid detection is still the basis for the diagnosis of covid-19 pneumonia infection. Negative antigen detection cannot replace negative nucleic acid proof.
several reagent manufacturers disclose production capacity and application progress
at present, many reagent manufacturers have also disclosed their production capacity to ensure supply
Zhejiang Orient Gene Biotech Co.Ltd(688298) today announced that the company’s covid-19 antigen detection reagent has a daily production capacity of about 18 million people. On the premise of ensuring technical indicators and product quality, the company will further improve the supporting capacity of production capacity, try its best to ensure the detection demand outside China, and give priority to meeting the needs of government centralized procurement and residents’ antigen self-detection.
On March 12, in an interview with the media, Beijing jinwofu biological staff revealed that there are 10 million orders at present. The company will increase the production capacity of antigen detection kit to 1.7 million people / day by adding people. 2000 workers will work in two shifts to start production and try their best to meet the needs of the Chinese market.
Guangzhou Wondfo Biotech Co.Ltd(300482) marketing department also disclosed that 33000 square meters of rapid diagnostic product industrialization base has been established, equipped with 5000 square meters of clean production workshop and rapid diagnostic reagent production line, with a daily output of 1.5 million people.
in addition, according to incomplete statistics of science and Innovation Board daily, 8 IVD listed companies including Jiangsu Bioperfectus Technologies Co.Ltd(688399) , Maccura Biotechnology Co.Ltd(300463) , Jiangsu Yuyue Medical Equipment And Supply Co.Ltd(002223) , Shenzhen New Industries Biomedical Engineering Co.Ltd(300832) , Daan Gene Co.Ltd(002030) , etc. have disclosed the application progress of covid-19 antigen products
Among them, Sansure Biotech Inc(688289) 3 said on the interactive platform on March 13 that covid-19 antigen detection products that can be used for home self-test have applied for EU CE certification and US FDA certification, which will further provide diversified identification and detection schemes for international epidemic prevention and control and improve the comprehensive competitiveness of the company’s products.
3 Zhejiang Kingland Pipeline And Technologies Co.Ltd(002443) said on the interactive platform on March 18 that the registration of covid-19 antigen detection reagent of Dean biology, a subsidiary, is actively applying, and the maximum daily output has been increased to 1 million people / day.
Beijing Strong Biotechnologies Inc(300406) 3 said on the interactive platform on March 14 that the company’s antigen detection reagents are mainly sold in Italy and other countries in Europe, and foreign manufacturers have obvious advantages in China’s entire diagnostic market. The company is actively promoting the application for covid-19 antigen testing Registration Certificate in China, and further assisting the prevention and control of covid-19 epidemic in China.
