Guangzhou Wondfo Biotech Co.Ltd(300482) : up to now, there is no antigen detection reagent product after the registration certificate has been changed for marketing, and no sales agreement has been reached with commercial retail OTC channels

Guangzhou Wondfo Biotech Co.Ltd(300482) issued a statement that the New Coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) developed by the company was approved by the State Drug Administration in November 3, 2020 to issue a medical device registration certificate (National weapon registration 20203400830) and a 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. So far, no antigen detection reagent products after the change of registration certificate have been put on the market. Up to now, the company has not yet reached a sales agreement with the commercial retail OTC channel of the Guangzhou Wondfo Biotech Co.Ltd(300482) New Coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) (national product licensing 20203400830) in March 12th, and has not yet sold such products.