On March 12, the State Food and Drug Administration issued a notice that the first batch of 5 new crown antigen self-test products were officially launched.
A reporter from China Securities Journal learned on March 13 that Meituan Buying has launched a self-testing product for COVID-19.
At the same time, chain pharmacies such as the People's Pharmacy and a number of pharmaceutical e-commerce platforms announced that they have reached cooperation or are in the process of connecting with approved manufacturers such as Wanfu Bio, and the self-tested products will be available for sale in the near future.
The brokerage research report believes that the new crown antigen test is expected to be widely used in China, and the market space is broad.
The e-commerce platform is the first to go online
On March 11, the National Health and Medical Commission announced that the comprehensive group of the Joint Prevention and Control Mechanism of the State Council decided to add antigen testing as a supplement on the basis of nucleic acid testing, and formulated and issued the "New Coronavirus Antigen Testing Application Plan (Trial)".
According to the plan, community residents who have self-test needs can purchase antigen test reagents for self-test through retail pharmacies, online sales platforms and other channels.
On March 12, the State Food and Drug Administration issued a notice to approve the changes in the self-testing application of new crown antigen products of Nanjing Novizan, Beijing Jinwofu, Shenzhen Huada Yinyuan, Guangzhou Wanfu Bio, and Beijing Huaketai Bio. 5 new crown antigen self-test products were officially launched.
A number of chain pharmacies and pharmaceutical e-commerce platforms have announced that they have reached cooperation with approved manufacturers or are in the process of docking, and self-tested products will be available for sale in the near future.
Among them, Yixintang and Wanfu Biotechnology and other 5 approved manufacturers of new crown antigen self-test products are cooperating.
On the evening of March 12, the official WeChat account of the "People's Pharmacy Group" announced that the People's Pharmacy and Guangzhou Wanfu Bio have reached a cooperation. The first batch of new crown antigen rapid test products have been in the process of logistics and transportation, and are expected to be sold in stores in the near future. .
The first batch of products will be launched in the stores of People's Pharmacy in 12 provinces and cities including Shanghai, Hunan and Jiangsu.
In addition, the new crown antigen self-test product has been launched on the e-commerce platform.
A reporter from China Securities Journal found that Meituan Buying Medicine has launched a self-testing product for the new crown antigen.
According to the relevant person in charge of Meituan Buying Medicine, from March 13, users can make an appointment to purchase related products through the pharmacies that deliver nationwide in the Meituan Buying Medicine channel, and merchants will use express delivery to deliver products to users from March 20; At the same time, Meituan Buying, in conjunction with the People's Pharmacy, Guoda Pharmacy, Gaoji Medical, Neptune Pharmacy, Dashenlin Pharmacy, Quanyuantang Pharmacy and other chain pharmacies, is expected to launch the new crown antigen self-testing products simultaneously with offline pharmacies within a week. Together, we provide users with a 30-minute door-to-door service.
In terms of other platforms, a reporter from China Securities News learned from Tmall Health on March 13 that the first batch of products will soon be available for online pre-sale, bringing consumers the brand's officially authorized antigen self-testing products as soon as possible.
The relevant person in charge of JD Health told the China Securities Journal reporter that JD Health is currently communicating with qualified brands, and will provide consumers with compliant, brand-authorized, and easy-to-buy antigen testing products as soon as possible. Check the product.
Strengthen supervision
Wanfu Bio issued a solemn statement on the evening of March 12, saying that recently, the company developed a novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) that has undergone changes to the medical device approval certificate. Now it is found that some individuals and Without the legal authorization of the company, the company conducts illegal sales and promotion through e-commerce and other online channels.
Wanfu Bio said that for the above-mentioned individuals and individuals who claim to be able to sell the new coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) products developed by the company through e-commerce and other online channels without the company's legal authorization, The company reserves the right to report the case to the relevant public security department and investigate the corresponding legal responsibility.
In order to strengthen supervision, on the evening of March 12, the General Department of the State Food and Drug Administration issued the "Notice on Doing a Good Job in the Quality and Safety Supervision of New Coronavirus Antigen Detection Reagents", proposing that all provincial drug supervision and management departments should strengthen the guidance of research and development registration links, Do a good job in the verification of the product registration quality management system for application registration to ensure that the enterprise research and development process is standardized, and the registration application materials are true, accurate, complete and traceable.
The notice proposes that local drug supervision and administration departments at all levels should further supervise and inspect enterprises operating new coronavirus antigen detection reagents, and supervise and guide enterprises to purchase new coronavirus antigen detection reagents from legally qualified medical device registrants and production and operation enterprises. Do a good job in purchasing inspection and sales records, and equip with appropriate facilities and equipment to ensure that product transportation and storage conditions meet the labeling requirements of labels and instructions.
Large market space
Industry insiders believe that the new crown antigen detection is an important supplement to the prevention and control of the new crown epidemic in my country. Antigen detection products are expected to be widely used in China and have a broad market space.
Novozan announced on the evening of March 13 that Novozan, a wholly-owned subsidiary, obtained the "Medical Device Registration Change Document (In Vitro Diagnostic Reagent)" approved by the State Food and Drug Administration on March 12, 2022.
The novel coronavirus antigen detection kit produced by Novozymes has completed the registration of the intended use of medical device products, the addition of sample types and changes in the contents of the instructions.
At the same time, Wanfu Bio and BGI also issued an announcement on changes to the registration system for antigen kits.
There are also listed companies that are actively applying.
Mingde Bio announced on the evening of March 13 that the company's new crown antigen detection reagent has submitted a registration application to the State Food and Drug Administration.
According to the research report of Zhongtai Securities, the domestic monthly market size is predicted to be 17.7 billion yuan to 26.6 billion yuan.
Taking into account the purchases of residents and enterprises at their own expense, it is expected that the purchase demand for new crown antigen detection products will further increase.
The research report believes that from a global perspective, there are currently more than 200 companies' new crown antigen kits on the market.
Among them, domestic brands have quickly occupied overseas markets with industry-leading inspection results and production and supply capabilities, and more than half of them have been approved.
Judging from the published product indicators and order procurement data, the leading domestic manufacturers have shown strong competitiveness. With the liberalization of the domestic market, relevant targets are expected to gain a leading edge.