In March 12th, Guangzhou Wondfo Biotech Co.Ltd(300482) ( 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 have illegally sold and publicized through electricity providers and other online channels without the legitimate authorization of our company.
On March 11, the National Health Commission issued the application scheme for covid-19 virus antigen detection (Trial), which clearly added antigen detection as a supplement on the basis of nucleic acid detection Guangzhou Wondfo Biotech Co.Ltd(300482) developed covid-19 antigen products were approved and issued with medical device registration certificate by the State Drug Administration, and the medical device approval certificate was changed on March 12, 2022. According to CCTV news, the five covid-19 antigen self-test products, including Guangzhou Wondfo Biotech Co.Ltd(300482) 's covid-19 antigen test products, have been officially launched.
In the statement, Guangzhou Wondfo Biotech Co.Ltd(300482) emphasized that the products of the company could not be used solely for the diagnosis of New Coronavirus infection. The infection status should be judged by combining nucleic acid detection, imaging and other diagnostic information, medical history and contact history. The positive results can be used for early shunting and rapid management of suspected populations, but positive results only indicate that New Coronavirus antigen exists in the samples, which can not be used as a diagnostic basis for New Coronavirus infection. Negative results can not exclude New Coronavirus infection, nor should it be used alone as a basis for treatment and disease management decisions. Further nucleic acid testing should be carried out for antigen positive and negative results of suspected people.
Guangzhou Wondfo Biotech Co.Ltd(300482) said that the company strictly manages the sales of the medical device products. Without the legal authorization of the company, it is not allowed to sell to the outside world or carry out false publicity activities. The company reserves the right to report the case to the relevant public security departments and investigate the corresponding legal liabilities of the above-mentioned individuals and companies who claim to be able to sell covid-19 antigen detection products developed by our company through e-commerce and other online channels without the legal authorization of our company.
According to the data on the official website, Guangzhou Wondfo Biotech Co.Ltd(300482) was founded in 1992, focusing on the innovative research and development of products and medical services in the field of in vitro diagnosis. It is a leading enterprise in the field of POCT in China and provides professional rapid diagnosis solutions for more than 140 countries and regions around the world. At the closing on March 11, Guangzhou Wondfo Biotech Co.Ltd(300482) 20% increased the limit to RMB 59.76, with a market value of RMB 26.59 billion.
It is worth mentioning that a few hours before Guangzhou Wondfo Biotech Co.Ltd(300482) announcement, two leading Chinese chain drugstore enterprises announced cooperation with Guangzhou Wondfo Biotech Co.Ltd(300482) .
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 have reached cooperation. The first batch of covid-19 antigen rapid test products have been in the process of logistics and transportation and are expected to be put on sale 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. Some media reported that 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 reagent, and Guangzhou Wondfo Biotech Co.Ltd(300482) covid-19 antigen self-test reagent will be "launched" in Dashenlin Pharmaceutical Group Co.Ltd(603233) offline stores on March 13
Lbx Pharmacy Chain Joint Stock Company(603883) pharmacy is about to launch the first batch of covid-19 self-test boxes and give the results in 15 minutes
As soon as tomorrow! The first five covid-19 self-test boxes sold in the drugstore may be cheaper than the quotation of 20 yuan
