Recently, the reporter of Shanghai Securities News learned from Thalys Medical Technology Group Corporation(603716) that Thalys Medical Technology Group Corporation(603716) has started the preparation for the type inspection of covid-19 antigen colloidal gold kit by the State Food and drug administration, and is ready to apply for the type inspection of the product from Wuhan biotechnology production base in Hubei Province and Changsha biotechnology production base in Hunan Province to the National Central Inspection Institute in Beijing. After completing the above steps and obtaining the inspection report, you can enter the preparation and process of product clinical trial and subsequent registration and declaration.
According to the relevant person in charge of the company, Thalys Medical Technology Group Corporation(603716) Thales biotechnology has developed a rapid detection kit for covid-19 IgM / IgG antibody, covid-19 antigen and covid-19 neutralizing antibody based on colloidal gold method during the epidemic last year and the year before, and has obtained the CE certification of the European Union and entered the export white list of the Ministry of Commerce. At present, the company has obtained a US $20 million covid-19 testing reagent procurement contract exported to the Turkish market.
The above-mentioned person in charge said that its covid-19 antigen rapid detection kit fully conforms to the policies announced by the state in terms of product design, detection principle, detection performance and use experience, and meets the current requirements for home self-test products.
In March 11th, the state Wei Jian administration announced that the State Council should have issued the notice on the issuance of the COVID-19 virus antigen detection application plan (Trial Implementation) in response to the joint prevention and control mechanism of New Coronavirus pneumonia in March 10th. It shows that the state will add antigen tests on the basis of nucleic acid detection as a supplement. According to the plan, community residents who need self-test can purchase antigen test reagents for self-test through retail pharmacies, online sales platforms and other channels.
According to the pending information of the medical device approval document (change) released on the website of the State Food and Drug Administration on March 12, by Guangzhou Wondfo Biotech Co.Ltd(300482) , Bgi Genomics Co.Ltd(300676) subsidiary Shenzhen Huada Yinyuan Pharmaceutical Technology Co., Ltd., Beijing jinwofu Bioengineering Technology Co., Ltd., Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) Medical Technology Co., Ltd Five covid-19 antigen detection kits developed by five companies of Beijing huaketai Biotechnology Co., Ltd. have passed the registration information change of the food and drug administration.
