On March 13, Guangzhou Wondfo Biotech Co.Ltd(300482) ( Guangzhou Wondfo Biotech Co.Ltd(300482) . SZ) announced that the covid-19 virus antigen detection kit developed by the company had changed the approval documents of medical devices on March 12. At present, the company is preparing the production materials before going online. As of the announcement date, no antigen detection reagent products after changing the registration certificate have been put on the market.
In March 11th, the State Council issued the “COVID-19 virus antigen detection application plan” (hereinafter referred to as the “plan”) for the New Coronavirus pneumonia epidemic prevention and control mechanism integrated group, and the plan decided to add antigen detection on the basis of nucleic acid detection. The reporter learned that the State Food and Drug Administration approved the listing of five covid-19 antigen self-test products on March 12, one of which is from Guangzhou Wondfo Biotech Co.Ltd(300482) . The reporter noted that on March 10 and 11, Guangzhou Wondfo Biotech Co.Ltd(300482) has closed two “20cm” limits in a row.
covid-19 antigen self test products approved for marketing
According to the plan, in order to further optimize the covid-19 virus detection strategy, according to the needs of epidemic prevention and control, the comprehensive group of joint prevention and control mechanism of the State Council decided to promote the monitoring mode of “antigen screening and nucleic acid diagnosis”, and add antigen detection as a supplement on the basis of nucleic acid detection.
The plan also stipulates the applicable groups for antigen testing: 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. Self testing can be conducted through the self testing platform and retail platform for residents who need to purchase reagents through the network.
On March 12, the State Food and Drug Administration issued a notice approving the application change of covid-19 antigen product self-test application of five companies, and five covid-19 antigen self-test products were officially listed, one of which was from Guangzhou Wondfo Biotech Co.Ltd(300482) . According to the announcement, New Coronavirus’s antigen detection kit (colloidal gold method) developed by Guangzhou Wondfo Biotech Co.Ltd(300482) was approved by the State Food and Drug Administration in November 3, 2020 to issue the medical device registration certificate, and the medical device approval document was changed in March 12, 2022.
The reporter noted that before the change, Guangzhou Wondfo Biotech Co.Ltd(300482) said that the above antigen detection products should be used by professionally trained personnel in an environment that ensures biosafety and meets the use conditions. After the change, the sampling method of nasal swab samples is added for the above products, and the applicable population shall refer to the relevant national regulations such as covid-19 virus antigen detection application scheme (Trial).
company denied that it had been listed for sale, after closing two “20cm” limit
Relevant departments have issued a document to add antigen detection as a supplement to nucleic acid detection. When can residents use antigen self-test reagent? It is reported that Guangzhou Wondfo Biotech Co.Ltd(300482) the first batch of antigen self-test reagents will be sold in retail pharmacies, online sales platforms and other channels.
In March 12th, Guangzhou Wondfo Biotech Co.Ltd(300482) issued a official account in WeChat public. The company found that some individuals and companies had not authorized the authorization to sell illegally through the electricity supplier and other online channels. The company and the company, which had not authorized the company’s legitimate authorization, passed the electricity supplier and other channels without authorization, declared that the products of the antigenic detection kit developed by the company could be sold. The company reserves the right to report the case to the relevant public security department and investigate the corresponding legal responsibility.
As of the 13th month after the announcement of the change of the registration document of the company, the product has not been put on the market, and the basis for the re registration of the product has not been put on record as of the 13th month after the change of the registration document of the company; As of the announcement date, the company has not reached a sales agreement with commercial retail OTC channels on antigen detection kit products, nor has it sold such products.
On the morning of March 14, the reporter of “daily economic news” contacted Guangzhou Wondfo Biotech Co.Ltd(300482) relevant persons and asked when the company’s antigen testing products would be put on the market, but did not get a clear reply. The reporter noted that Guangzhou Wondfo Biotech Co.Ltd(300482) has closed two “20cm” limit in the previous two trading days.
