covid-19 virus antigen self-test product was approved for listing, but Guangzhou Guangzhou Wondfo Biotech Co.Ltd(300482) was controversial. The core of the dispute was not the product quality and price, but a wechat circle of friends message from the company’s board secretary that could not hide “joy”
In March 14th, Guangzhou Wondfo Biotech Co.Ltd(300482) issued a notice on the approval of the New Coronavirus antigen test kit approval document, and changed the intended use of the product. Previously, Guangzhou Wondfo Biotech Co.Ltd(300482) was one of the first batch of enterprises approved for antigen self-test reagent in China.
As of the closing on March 14, Guangzhou Wondfo Biotech Co.Ltd(300482) shares closed at 61.98 yuan / share, up 3.17%.
Secretary of the board of directors “happiness begets sorrow”
As shown in the figure above, Guangzhou Wondfo Biotech Co.Ltd(300482) share price has risen for three consecutive trading days. From 41.5 yuan / share on March 9, it quickly rose to the intraday peak of 71 yuan / share on March 14, an increase of 71%. Coupled with the large market expectation space, it is estimated that there is still a great possibility of continued rise.
Guangzhou Wondfo Biotech Co.Ltd(300482) is indeed lucky. Among the first batch of approved enterprises, the products of Guangzhou Wondfo Biotech Co.Ltd(300482) , Beijing jinwofu Bioengineering Technology Co., Ltd., Shenzhen Huada Yinyuan under Bgi Genomics Co.Ltd(300676) and Beijing huaketai Biotechnology Co., Ltd. have become the focus of market attention. They are indeed the beneficiaries of policy dividends. From the performance and stock price trend of nucleic acid testing enterprises, we can see that the future of home self-test products is not bad. However, to people’s surprise, the Board Secretary of one enterprise can’t sit still before the kit is on the market.
On March 12, Guangzhou Wondfo Biotech Co.Ltd(300482) Secretary released a circle of friends with “the mood is as follows at the moment and equipped with ‘ahahahaha'” expression pack, which immediately caused a storm of public opinion.
Dong’s circle of friends has caused many disputes, and netizens have accused him of “making a country difficult to make money”. So Guangzhou Wondfo Biotech Co.Ltd(300482) was put on the cusp of public opinion.
At noon on March 13, Guangzhou Wondfo Biotech Co.Ltd(300482) Secretary apologized in his wechat circle of friends, saying: “yesterday, I was in the circle of friends because of my personal affairs. It was really my thoughtlessness and didn’t realize that everyone’s anxiety at the moment of the epidemic had a negative impact. I have deleted the relevant contents for the first time, and I sincerely apologize to you here.”
Previously, due to the explosion of covid-19 test reagent and other reasons, Guangzhou Wondfo Biotech Co.Ltd(300482) secondary market gained a lot. After Guangzhou Wondfo Biotech Co.Ltd(300482) 20cm limit on March 10, Guangzhou Wondfo Biotech Co.Ltd(300482) increased again on March 11, with an increase of 44% in two days, and the market value expanded by more than 8 billion yuan.
Since January this year, Guangzhou Wondfo Biotech Co.Ltd(300482) share price has experienced two declines. In February, its share price was still 34.12 yuan / share, and then in March, its share price started to rise all the way. It once hit 71 yuan / share, with an increase of 51.94%, doubling. Overall, although the secondary market of Guangzhou Wondfo Biotech Co.Ltd(300482) has been declining frequently since April 2021, it is now almost the same as the highest share price of 81.15 yuan / share last year due to covid-19 test and other factors.
urgent clarification
According to public information, Guangzhou Wondfo Biotech Co.Ltd(300482) was founded in 1992. Its initial business was to export drug testing and pregnancy testing products to the United States and Europe, and was successfully listed in 2015. At present, its main business is divided into infectious disease detection, chronic disease detection, drug (drug abuse) detection, pregnancy and eugenics detection, etc.
After the State Food and Drug Administration released the covid-19 self-test plan, Guangzhou Wondfo Biotech Co.Ltd(300482) as the first approved enterprise, its products were frequently named by offline commercial retailers including Lbx Pharmacy Chain Joint Stock Company(603883) , Dashenlin Pharmaceutical Group Co.Ltd(603233) , Yifeng Pharmacy Chain Co.Ltd(603939) , Ping An Health and tmall health from March 12 to March 13, and announced that their own platforms could purchase covid-19 test reagents.
It is puzzling that on March 13, Guangzhou Wondfo Biotech Co.Ltd(300482) suddenly issued a media Clarification Announcement, saying that the company is preparing production materials before going online according to the approved medical device change registration (filing) documents, and as of the date of this announcement, there is no antigen detection test product after the change of registration certificate on the market. It was also clarified that the company had 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.
screenshot of Guangzhou Wondfo Biotech Co.Ltd(300482) announcement
At the same time, Guangzhou Wondfo Biotech Co.Ltd(300482) also published the same content on its WeChat official account, but it was deleted in an hour.
In addition, in March 12th, Guangzhou Wondfo Biotech Co.Ltd(300482) issued a statement on its WeChat official account, which reserved the right to report to the relevant public security departments and to pursue corresponding legal liabilities for the illegal sale and publicity of individuals who did not illegally pass the company’s legal authorization.
Guangzhou Wondfo Biotech Co.Ltd(300482) official wechat screenshot
It is not difficult to find by comparing the statements before and after Guangzhou Wondfo Biotech Co.Ltd(300482) 3. The prominent content clarified on the evening of March 13 is that the company has not sold the products after the registration certificate has been changed.
It is reported that in November 2021, Guangzhou Wondfo Biotech Co.Ltd(300482) ‘s New Coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) products received emergency approval, which was previously used for professional medical use, that is, “this product should be used by professional trained personnel to ensure biosafety and meet the conditions of use.” According to the announcement on the change of product approval documents issued on March 13, the column of the latest product in the expected use has been changed to self-use, that is, “the applicable population shall refer to the relevant national regulations such as covid-19 virus antigen detection application scheme (Trial)”.
It should be noted that according to the regulations on the administration of instructions and labels of medical devices issued by the State Food and Drug Administration in 2014, it is mentioned that “all medical devices sold and used in the people’s Republic of China shall be attached with instructions and labels in accordance with the requirements of these Regulations”. This also means that it is illegal to sell “old products” when the product manual has not been updated.
This may explain why Guangzhou Wondfo Biotech Co.Ltd(300482) issued an urgent statement.
However, it is worth noting that at present, more than Guangzhou Wondfo Biotech Co.Ltd(300482) one antigen detection kit is an emergency approved product at the end of 2021. Covid-19 test kits of Beijing jinwofu biology and Huada Yinyuan under Bgi Genomics Co.Ltd(300676) are also emergency approved products. They can be officially sold only after waiting for their product change instructions and registration certificate. If they are sold in advance, there is also a risk of violation.
In fact, although most approved enterprises are constantly announcing their partners, their products are still in the state of pre-sale or about to go online.
In addition, among the 10 approved pharmaceutical enterprises that have been announced, Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) , Bgi Genomics Co.Ltd(300676) and Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) announced the prices of their test kits. According to the latest data of jd.com platform, the price of Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) test kit is 486 yuan / 20 people, Bgi Genomics Co.Ltd(300676) 490 yuan / 20 people, Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) 268 yuan / 10 people, with an average price of around 25 yuan.
