Guangzhou Wondfo Biotech Co.Ltd(300482) reissue the statement!
In March 13th, Guangzhou Wondfo Biotech Co.Ltd(300482) ( Guangzhou Wondfo Biotech Co.Ltd(300482) ) issued a statement saying that as of now, has not yet reached a sales agreement with the commercial New Coronavirus retail (OTC) channel, which has changed the registration certificate in March 12th, and has not yet sold such products as the Guangzhou Wondfo Biotech Co.Ltd(300482) 2019-nCoV (2019-nCoV) antigen detection kit (colloidal gold method) and the commercial retail OTC channel.
Guangzhou Wondfo Biotech Co.Ltd(300482) means, Concerned about the media's release of the Titles: Dashenlin Pharmaceutical Group Co.Ltd(603233) the first batch of antigen testing agent boxes in Shenzhen store have not arrived Guangzhou Wondfo Biotech Co.Ltd(300482) 19.3 yuan / time, covid-19 antigen self-test products are delayed or relevant qualifications need to be supplemented, and "exclusive Dashenlin Pharmaceutical Group Co.Ltd(603233) and Guangzhou Wondfo Biotech Co.Ltd(300482) sign a strategic cooperation agreement on covid-19 antigen self-test agent sales" "Covid-19 can also be measured at home, and the results will be obtained in 15 minutes! Lbx Pharmacy Chain Joint Stock Company(603883) large pharmacy is about to open its first batch...", According to these reports, " Dashenlin Pharmaceutical Group Co.Ltd(603233) all employees have sent a circle of friends about the upcoming sale of antigen detection reagents", " Dashenlin Pharmaceutical Group Co.Ltd(603233) and Guangzhou Wondfo Biotech Co.Ltd(300482) have signed a strategic cooperation agreement on the distribution of covid-19 antigen self-test reagents, and Guangzhou Wondfo Biotech Co.Ltd(300482) covid-19 antigen self-test reagents will be 'launched' in Dashenlin Pharmaceutical Group Co.Ltd(603233) offline stores tomorrow" "At present, Guangzhou Wondfo Biotech Co.Ltd(300482) has been required to be temporarily removed from the OTC channel and put on the shelf again after replacing the product manual because there is no manual for replacing the antigen detection reagent." Lbx Pharmacy Chain Joint Stock Company(603883) pharmacy and Guangzhou Guangzhou Wondfo Biotech Co.Ltd(300482) have reached cooperation. The first batch of covid-19 antigen rapid detection products have been on the way of logistics and transportation and are expected to be put on the shelves in stores in the near future. ".
Guangzhou Wondfo Biotech Co.Ltd(300482) said that the New Coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) developed by the company was approved by the State Administration of drug supervision and approval in November 3, 2020, and the medical device registration certificate (20203400830) was approved by the State Administration of drug control. The medical device approval document was changed in March 12, 2022. after the change of the above-mentioned medical device approval documents, the company is preparing the production materials before going online according to the approved medical device change registration (filing) documents. Up to now, there is no antigen detection reagent product after the change of registration certificate on the market
Prior to March 12th, Guangzhou Wondfo Biotech Co.Ltd(300482) issued a statement that recently, the New Coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) developed by the company has changed the approval documents of medical devices. It has been found that some individuals and companies illegally sell and publicize through the electricity supplier and other online channels without the legitimate authorization of our company.
On March 12, the State Food and Drug Administration approved the application 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, and five covid-19 antigen self-test products were officially launched. After the news came out, many chain drugstores and pharmaceutical e-commerce announced that they had reached cooperation with Guangzhou Wondfo Biotech Co.Ltd(300482) and other manufacturers and would be on sale. For example, meituan could make an appointment to buy covid-19 antigen self-test products.
It is noteworthy that Guangzhou Wondfo Biotech Co.Ltd(300482) mentioned Lbx Pharmacy Chain Joint Stock Company(603883) large pharmacy and Dashenlin Pharmaceutical Group Co.Ltd(603233) two chain pharmacy enterprises in its latest statement.
On March 12, according to the wechat account of Lbx Pharmacy Chain Joint Stock Company(603883) pharmacy group, Lbx Pharmacy Chain Joint Stock Company(603883) pharmacy and Guangzhou Guangzhou Wondfo Biotech Co.Ltd(300482) pharmacy reached a cooperation. The first batch of covid-19 antigen rapid test products have been on the way of logistics and transportation and are expected to be sold in stores in the near future. The first batch of products will be landed in the stores of Lbx Pharmacy Chain Joint Stock Company(603883) pharmacy in 12 provinces and cities including Shanghai, Hunan and Jiangsu.
On March 12, some media reported that Dashenlin Pharmaceutical Group Co.Ltd(603233) and Guangzhou Wondfo Biotech Co.Ltd(300482) had signed a strategic cooperation agreement on the distribution of covid-19 antigen self-test reagent, and Guangzhou Wondfo Biotech Co.Ltd(300482) covid-19 antigen self-test reagent would be "launched" in Dashenlin Pharmaceutical Group Co.Ltd(603233) offline stores on March 13.
