Pharmaceutical biology weekly (week 11, 2022): a number of pharmaceutical enterprises were listed in the SEC’s preliminary delisting list, and covid-19 antigen detection scheme was released

The SEC of the United States disclosed the “preliminary delisting list”, which included three China Meheco Group Co.Ltd(600056) companies. On March 10, the SEC Website disclosed that five companies were included in the “preliminary delisting list” due to the foreign company Accountability Act (hfcaa), and Baiji Shenzhou, zaiding pharmaceutical and Hehuang pharmaceutical were listed, causing the share prices of three companies to plummet. We think there is no need for excessive panic: on the one hand, for issuers identified by the list for three consecutive years, the SEC will impose a ban on their first trading, which means that relevant companies have a three-year buffer period to introduce “joint audit” by audit institutions that meet the requirements of PCAOB; On the other hand, the “three listed companies of Huangji and Baiji” are expected to further improve the financial transparency.

Many covid-19 antigen self-test products have been approved, which is expected to become a powerful supplement to nucleic acid detection. On March 11, the official website of the Health Commission released the application scheme for covid-19 virus antigen detection (Trial). On March 11-12, the website of the State Food and Drug Administration released the approval document (change) of medical devices. The information to be received showed that the application for self-test application of covid-19 antigen products of Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) , Beijing jinwofu, Shenzhen Huada Yinyuan, Guangzhou Guangzhou Wondfo Biotech Co.Ltd(300482) , and Beijing huaketai biology was approved. We believe that: 1) antigen detection is an important supplement to nucleic acid detection. In the pilot application scheme, it will be used for symptomatic personnel, isolation observers and community residents with self-detection needs in grass-roots medical institutions. Because antigen detection is fast and simple, it can be used for early detection and rapid disposal of infectious sources, intercepting and blocking the spread of the epidemic, enriching the toolkit for epidemic prevention and control; 2) At present, five products in China have been approved for self-test qualification, involving colloidal gold method, fluorescence immunochromatography and latex method. With the gradual promotion of the application of antigen detection in China, it is expected that more manufacturers will be approved for self-test products under the legal registration process to gradually meet the market demand.

Follow up the changes of the epidemic situation and pay attention to the leading enterprises in the approval of antigen products and capacity expansion. The application scheme of covid-19 antigen detection (Trial) issued by the health commission will significantly increase the demand for antigen detection reagents in China. Suggestions: 1) manufacturers whose products have been approved in China: Guangzhou Wondfo Biotech Co.Ltd(300482) , Nanjing Vazyme Biotech Co.Ltd(688105) , Bgi Genomics Co.Ltd(300676) ; 2) Manufacturers that have been approved overseas and have sufficient production capacity: Zhejiang Orient Gene Biotech Co.Ltd(688298) , Beijing Hotgen Biotech Co.Ltd(688068) , anxiu biology, Shenzhen Yhlo Biotech Co.Ltd(688575) .

Risk tips: covid-19 epidemic situation changes, antigen product promotion is not as expected, and false positive or false negative problems occur in antigen detection

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