The first batch of covid-19 antigen detection products for self-test have been approved!
On March 12, China Central Television reported that the State Food and Drug Administration issued a notice approving the change of covid-19 antigen product self-test application of Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) , Beijing jinwofu, Shenzhen Huada Yinyuan, Guangzhou Guangzhou Wondfo Biotech Co.Ltd(300482) , Beijing huaketai biology. Since then, five self-test products of vid-19 antigen have been officially launched.
On the same day, the latest pending information released on the government portal of the State Food and drug administration showed that the approval documents (changes) of medical devices obtained by the four covid-19 antigen detection kit products were pending on March 12, involving four companies, including Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) ( Nanjing Vazyme Biotech Co.Ltd(688105) , Nanjing Vazyme Biotech Co.Ltd(688105) ) wholly-owned subsidiary Nanjing Vazyme Biotech Co.Ltd(688105) Medical Technology Co., Ltd Guangzhou Wondfo Biotech Co.Ltd(300482) ( Guangzhou Wondfo Biotech Co.Ltd(300482) , Guangzhou Wondfo Biotech Co.Ltd(300482) ), Bgi Genomics Co.Ltd(300676) ( Bgi Genomics Co.Ltd(300676) ) subsidiaries Shenzhen Huada Yinyuan Pharmaceutical Technology Co., Ltd. and Beijing jinwofu Bioengineering Technology Co., Ltd.
Plus Beijing huaketai, which was approved to change the previous day, the number of manufacturers approved to change has increased to five.
On March 11 of the previous day, the information to be received released on the government portal of the State Food and drug administration showed that the medical device approval certificate (change) of covid-19 antigen detection product of Beijing huaketai Biotechnology Co., Ltd. was to be received, and the approval date was March 11.
At present, five covid-19 antigen detection products of five enterprises in China have been approved, which are the products with changed information. Previously, these products were only approved for professional use, not self-test. The State Food and drug administration did not disclose the details of the product change of the information to be received for the change announced this time. Some people in the industry believe that the information changed this time may be allowed to be used for residents’ self-test.
On March 12, the surging news reporter contacted the service hotline of Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) and a staff member said on the phone that at present, the change information of covid-19 antigen detection products on the official website of the food and drug administration has indeed changed from the professional version to the self-test version. The above staff member said that it is not clear whether the self-test version will be produced or not.
Also on March 11, the National Health Commission issued the application plan on printing and distributing covid-19 virus antigen detection (Trial), which made it clear to add antigen detection as a supplement on the basis of nucleic acid detection. It mentioned that if community residents have self-detection needs, they can purchase antigen detection reagents for self-test through retail pharmacies, online sales platforms and other channels.
Just one day later, five covid-19 antigen self-test products were officially launched.
The surging news reporter noted that currently, only three covid-19 antigen products of Guangzhou Wondfo Biotech Co.Ltd(300482) ( Guangzhou Wondfo Biotech Co.Ltd(300482) , Guangzhou Wondfo Biotech Co.Ltd(300482) ), Bgi Genomics Co.Ltd(300676) subsidiaries Shenzhen Huada Yinyuan Pharmaceutical Technology Co., Ltd. and Beijing jinwofu Bioengineering Technology Co., Ltd. are displayed in the medical device product (Registration) database of the State Food and drug administration, and the product details have not been changed, It should still be used by professionally trained personnel in an environment that ensures biosafety and meets the conditions for use.
The approval or change of covid-19 antigen detection products involves Nanjing Vazyme Biotech Co.Ltd(688105) , Guangzhou Wondfo Biotech Co.Ltd(300482) , Bgi Genomics Co.Ltd(300676) three listed companies. As of the closing on March 11, Nanjing Vazyme Biotech Co.Ltd(688105) closed up 17.47% to 106.29 yuan, with a market value of 42.52 billion yuan Guangzhou Wondfo Biotech Co.Ltd(300482) 20% limit, at 59.76 yuan, with a market value of 26.59 billion yuan Bgi Genomics Co.Ltd(300676) closed up 10.99% to 89.4 yuan, with a market value of 37 billion yuan.
