According to the information of the official website China Food and Drug Administration, in March 18th, the 3 Shanghai COVID-19 antigen detection reagent products were approved.

Up to now, China Food and Drug Administration has approved 17 COVID-19 antigen detection reagents.

100 billion market or expected

It is reported that on March 11, the National Health and Medical Commission issued the "Notice on Printing and Distributing the New Coronavirus Antigen Detection Application Plan (Trial)". As a supplement, and organized the formulation of the "New Coronavirus Antigen Detection Application Plan (Trial)" (hereinafter referred to as "the plan")

Officials show that up to now, the State Food and Drug Administration has successively approved including Beijing Savant Biotechnology Co., Ltd., Nanjing Vazyme Biotech Co., Ltd., Beijing Jingwofu Bioengineering Technology Co., Ltd, Bgi Genomics Co., Ltd., Guangzhou Wondfo Biotech Co., Ltd., Beijing Wantai Biological Pharmacy Enterprise Co. ,Ltd, Beijing Hotgen Biotech Co., Ltd., Bioscience( Tianjin ) Diagnostic Technology Co., Ltd, Wuhan Easy Diagnosis Biomedicine Co., Ltd., Lepu Medical Technology(Beijing) Co., Ltd., Chongqing M&d Biotechnology Co. Ltd., Zhejiang Orient Gene Biotech Co., Ltd., Aikang Bio-Technology Hangzhou Co., Ltd … 17 registration applications for novel coronavirus antigen/antibody detection kit products.

With the implementation of the policy, several institutions have forecasted the domestic demand for antigen detection reagents. Zheshang Securities believes that considering only the three types of scenarios in the "Plan", with the implementation of subsequent policies, the following market space is expected to be opened in the future. The annual testing market space is about 62 billion (CNY), and the market for reagents The space is about 38 billion, and the total potential market space is nearly 100 billion.

But as to whether it can replace nucleic acid testing, Wu Jinglei, director of the Shanghai Municipal Health Commission, claims that the new crown antigen test is mainly used for rapid population screening and triage management to shorten the chain of transmission. It is easy to implement, but the disadvantage is that the sensitivity is not as good as that of nucleic acid detection, which may lead to missed diagnosis.

A few reagent manufacturers disclose application progress

According to incomplete statistics from the "Science and Technology Innovation Board Daily", 8 listed IVD companies, including Jiangsu Bioperfectus Technologies Co., Ltd., Maccura Biotechnology Co., Ltd., Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., Shenzhen New Industries Biomedical Engineering Co., Ltd. Daan Gene Co., Ltd. have disclosed the progress of the declaration of COVID-19 antigen products.