Per reporter: Lin Zichen Ye Xiaodan Xu Libo Chen Xing Per reporter: Dong Xingsheng, He Xiaotao
Recently, the domestic epidemic has broken out in many places. On March 12, Jilin Province alone added 1412 (confirmed cases) + 744 (asymptomatic infected people). In the case of the rapid increase in confirmed cases, improving the efficiency of testing and avoiding the expansion of the epidemic has become the key to the current epidemic prevention and control work.
Antigen testing, which has just been officially "stamped" and has become a helper for nucleic acid testing, has high hopes. On the 12th, 5 new crown antigen testing products were approved for listing, and manufacturers, chain pharmacies, and e-commerce platforms quickly cooperated to join the product shop race.
However, the loading situation in different cities is not the same. On the afternoon of the 13th, the Daily Economic News reporter visited pharmacies in many cities in China and found that many pharmacies in Shanghai, Nanjing and other places are expected to receive products this week, and the unit price is about 20 yuan to 30 yuan.
Considering the large number of manufacturers holding antigen detection products in China, the competition in the new crown antigen self-test market will be more intense in the future. However, it is worth noting that nucleic acid testing is still the current gold standard for the determination of new crown infection, and the State Food and Drug Administration has also clearly stated that it will "further strengthen the product quality and safety supervision of new coronavirus antigen detection reagents".
Chain pharmacies quickly cooperated
The unit price is 20 yuan to 30 yuan
On March 10, the Comprehensive Group of the Joint Prevention and Control Mechanism of the State Council decided to add antigen testing as a supplement to nucleic acid testing. Relevant documents point out that if community residents have self-testing needs, they can purchase antigen detection reagents for self-testing through retail pharmacies, online sales platforms and other channels.
On the 12th, the State Food and Drug Administration issued a notice approving the application change of the application application of the new crown antigen products of Nanjing Novizan, Beijing Jinwolf, Shenzhen Huada Inyuan, Guangzhou Wanfu Biology and Beijing Huaketai Biology, and five new crown antigen self-test products were officially listed.
After obtaining market admission tickets, the speed of shop has become an important factor for each product to occupy the market, and chain pharmacies have become an indispensable stop.
A piece of information provided to reporters by the People's Pharmacy shows that the People's Pharmacy has reached a cooperation with Guangzhou Wanfu Biologics, and the first batch of new crown antigen rapid test products have been distributed in stores, and are expected to be sold in stores in the near future. The first batch of products will land in 12 provinces and cities stores including Shanghai, Hunan and Jiangsu.
On the afternoon of the 13th, during the offline visit, the reporter found that some pharmacies in Shanghai had "grabbed the heat" in advance and advertised the new crown virus antigen detection kit. When the reporter asked about the relevant products, some clerks said that they also just learned that the new crown antigen self-test products were about to be listed the day before, but the store has not yet been supplied. "It can only be booked at present, and it may not be until next Tuesday or Wednesday to get the goods." The price of the product is roughly in the twenties, and the total price of a box of 10 is more than 200 yuan. ”
Some pharmacies "grab the heat" in advance Image source: Per the reporter Xu Libo photographed
Pharmacy staff told reporters that after the new crown antigen test kit is available in the store, users can either come to the offline store to buy, or they can buy through online platforms such as Ele.me and Meituan.
At a Jingdong Health Alliance pharmacy and a Neptune Star Pharmacy in Beijing, the clerks said that there are no new crown antigen self-test products on the shelves in the store. "There may be a notice next Monday, we'll see." For customers who came to inquire about the purchase of new crown antigen testing products, neptune star clerks took the initiative to provide enterprise WeChat, saying that they would notify online after the products were listed.
In Chengdu, where the epidemic situation is relatively relaxed, the reporter also visited many pharmacies such as Neptune Star and Gaoji Pharmacy, and the clerks said that there were no new crown antigen test kits for sale. Neptune Star Pharmacy clerk said, "At present, there is no notice from the company to go on the shelves, this depends on whether the company has goods." We don't have it now, and it's hard to say if we will have it in the future."
A pharmacy in Chengdu has not yet been sold Image source: Photo by reporter Chen Xing
But the speed at which products are on the shelves also varies from pharmacy to pharmacy. According to relevant media reports, a large pharmacy store in Shanghai said that Wanfu Bio's new crown antigen self-test products are still in the large warehouse of Hunan headquarters, and shanghai pharmacies still need to build new catalogs and higher-level approvals before they can be put into storage; some pharmacies also need to handle the qualification to sell this product, which needs to go to the Food and Drug Administration for the record, "it is expected to take 2 weeks to buy on the shelves."
According to other media reports, the Shenzhen store of Dashenlin received a notice that the product was about to go online. The store has not yet received the product, but all the staff have sent a circle of friends about the news that the new crown antigen detection reagent is about to be sold on the shelves, and have received customer inquiries. It is reported that Wanfu Bio's new coronavirus antigen detection kit is priced at 386 yuan / box offline, containing 20 reagents, that is, the price of a single test is 19.3 yuan.
E-commerce has become an active force
"Impatient" online sellers have been publicly condemned
Compared with offline pharmacies, e-commerce platforms have taken a step ahead.
On March 13, Meituan bought drugs to launch a new crown antigen self-test product. Users log on to the Meituan App or meituan takeaway App to enter the drug buy channel, you can make a purchase in the page, in addition, Meituan buy medicine also set up a "new crown self-test" area in the channel to display relevant product information.
According to the above steps, at noon on the 13th, the reporter searched for the new crown antigen self-test product on the Meituan platform. The page shows that the new crown antigen self-test product currently on the Meituan platform is produced by Jinwolf, and the current price is 32.8 yuan / copy, but it shows that it is "sold out".
In the "COVID-19 self-test only takes 15 minutes" section, product photos show that "it is expected to be shipped in about 15 days" and "it is expected to be shipped on March 20".
Image source: Meituan buys medicine
According to the relevant person in charge of Meituan Buying Drugs, users can make an appointment to purchase related products through pharmacies shipped nationwide in the Meituan Buying Channel, and merchants will use express delivery for users from the 20th; at the same time, Tuanbuy Medicine has also joined hands with the people's pharmacy, NUS Pharmacy, GaoJi Medical, Neptune Star, Dashenlin Pharmacy, Quanyuantang Pharmacy and many other chain pharmacies, and is expected to launch the new crown antigen self-test products synchronously with offline pharmacies within a week to jointly provide users with 30 minutes of drug delivery service.
In addition, Jingdong Health also said that at present, in communication with brands with relevant qualifications, it will provide consumers with compliant, brand-authorized, and convenient antigen testing self-test products for the first time; Ping An Good Doctor said that the first batch of new crown antigen self-testing agent boxes are about to be launched, users can make an appointment to buy in the Ping An Health APP, and the platform will also launch the self-testing agent box in the form of a specialist service package on the doctor's workbench, and orders can be purchased after the official sale.
GaoJi Medical said that it is working closely with Guangzhou Wanfu Biological, Nanjing Nuoweizan, Shenzhen Huada Ingenyuan, Beijing Jinwolf and many other companies, and the first batch of new crown antigen rapid test products will soon be sold in Henan, Jiangxi and Liaoning markets, and will provide online ordering services for customers across the country through the Gaoji Health Pro WeChat Mini Program.
However, some manufacturers are too "anxious" to push new crown antigen testing products online and are publicly condemned by brand companies.
On the evening of March 12, Wanfu Biologics, a domestic manufacturer of new crown antigen testing products, issued a solemn statement, saying that the new coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) recently developed by the company has changed the medical device approval documents, and found that some individuals and companies have carried out illegal sales publicity through e-commerce and other online channels without the company's legal authorization.
Wanfu Bio said that the above products can not be used alone for the diagnosis of new coronavirus infection, and should be combined with other diagnostic information such as nucleic acid detection and imaging, as well as medical history and contact history to determine the infection status. A positive result can be used for early triage and rapid management of suspected populations, but a positive result only indicates the presence of a novel coronavirus antigen in the sample and cannot be used as a basis for confirming the diagnosis of novel coronavirus infection. A negative result does not exclude novel coronavirus infection and cannot be used alone as a basis for treatment and disease management decisions. Positive and negative antigens in suspected populations should be tested for further nucleic acid testing. The company implements strict management of the sales of medical device products, and if it is not legally authorized by the company, it shall not sell to the outside world without authorization and carry out false publicity activities.
It began in parts of Hangzhou
Free distribution of "COVID-19 antigen self-testing agent"
It is worth noting that on the evening of March 13, the reporter learned that the owners of yuhang districts and shangcheng districts in Hangzhou city received an emergency notice in the owner group, in order to prevent and control the epidemic, the new crown virus antigen self-test work was carried out that night, and the testing method was to distribute tools to the door for self-testing.
"Daily Economic News" reporter learned from multiple channels that among the free self-test products issued by Yuhang District for multiple communities, there are Botuo Biological (688767. SH) produced RightSign rapid detection reagent for new crown antigens. There are also antigen self-testing kits produced by Hangzhou Laihe Biotechnology Co., Ltd. (hereinafter referred to as "Laihe Biological") that the antigen self-test agent received by the owners of the community is also the self-test kit.
Image source: Circle of Friends screenshot
According to previous media reports, in March 2021, Laihe Biotech's rapid self-test products were approved for marketing by the German Federal Institute of Drugs and Medical Devices (Bfarm).
In January 2022, Botuo Bio said in an investor survey that the new crown antigen OTC certificate that the company has obtained is mainly CE certificate and TGA certificate, and can sell new crown antigen OTC products in countries and regions that recognize CE and TGA certificates.
On the evening of the 13th, the reporter tried the RightSign test reagent issued by the community staff in Yuhang District, and the self-test kit could display the results within a few minutes after the nasal swab was wiped.
Image source: Photo by reporter Ye Xiaodan
Previously, on the evening of March 11, the State Food and Drug Administration issued a notice approving the application change of the application application for the self-test of new crown antigen products in Nanjing Novizan, Beijing Jinwolf, Shenzhen Huada Inyuan, Guangzhou Wanfu Biology, and Beijing Huaketai Biology. Since then, 5 new crown antigen self-test products have been officially launched. However, the reporter also noted that it did not include the products of Botuo Bio and Laihe Bio.
New crown antigen self-testing agent Image source: Per reporter Ye Xiaodan photo
In the capital market, on March 11, the new crown testing sector set off a rising tide, and more than 20 individual stocks won the up and down board. On March 11, the stock price of Botuo Bio rose by 20%, closing at 109.80 yuan / share.
Official: There is no substitute for nucleic acid testing, and supervision will be strengthened
According to the Kaiyuan Securities Research Report, as the domestic epidemic situation gradually becomes more severe, the performance of companies with first-mover advantages will be released in the enlargement of the demand for antigen detection in the domestic epidemic prevention and control, and the listed company Wanfu Bio (300482. SZ), BGI Gene (300676. SZ), Novizan (688105. SH) will benefit directly.
Some investors also told reporters that the opening of the floodgates of new crown antigen testing products is absolutely positive for the market, and this sentiment can be seen from the enthusiasm of the soaring stock prices of companies in the new crown testing sector on Friday (March 11).
However, it is worth noting that due to the high sensitivity and better specificity of nucleic acid detection, it is still the "gold standard" for the current diagnosis of new crown pneumonia, and antigen detection is still a "supporting role" in the new crown testing work.
On March 11, the document released by the National Health Commission also made it clear that nucleic acid testing is the basis for confirming the diagnosis of new coronavirus infection. In the process of nucleic acid test confirmation, if the nucleic acid test is positive, regardless of whether the antigen test result is positive or negative, corresponding measures are taken according to the new crown virus infection or the new crown pneumonia confirmed patient; if the nucleic acid test is negative but the antigen test is positive, it is regarded as the new crown virus infected person to take measures such as centralized isolation, close observation, and continuous nucleic acid testing.
When the reporter visited, there are also people's large pharmacy store staff tips, the new crown antigen detection kit is only used for self-testing, the effect and authority is certainly not as good as the hospital nucleic acid test results, can not replace the nucleic acid test report, if the user has a business trip, you can bring your own kit, but it is best to get the nucleic acid test report in the hospital.
In this context, antigen detection products act as a detection outpost, and their product regulatory requirements are more stringent. On March 12, the Comprehensive 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", saying that in order to effectively ensure the product quality and safety of new coronavirus antigen detection reagents and further strengthen the product quality and safety supervision of new coronavirus antigen detection reagents, specific requirements were put forward from four aspects: "strengthening registration-related management work", "strengthening production supervision and inspection", "strengthening supervision and inspection of business links" and "severely cracking down on violations of laws and regulations".
At the same time, the vast market still attracts many manufacturers to enter. On the evening of the 13th, Matilda Bio (002932. SZ) disclosed that the company's new crown antigen detection reagent has submitted a registration application to the State Drug Administration, and the timing of the registration certificate is still uncertain.
It is worth noting that there are not many manufacturers in China who really hold antigen detection kit products, and they have previously targeted overseas markets. According to the statistics of Tianfeng Securities on March 8, there are currently 94 Chinese antigen testing products certified by the EU CE, 3 products in the United States EUA, and more products with new crown antigen testing.
Antigen self-testing agent box manufacturers to take the certificate to sort out the picture source: Tianfeng Securities
Therefore, it is not difficult to foresee that the relevant products in the market will continue to increase in the future, and the speed of listing/distribution largely determines the company's market discourse. Previously, Kaiyuan Securities had said that with the gradually severe domestic epidemic situation, antigen detection related products have the possibility of accelerating, and the performance of companies with first-mover advantages will be released in the amplification of the demand for antigen detection in domestic epidemic prevention and control.
(The content and data of the article are for reference only and do not constitute investment advice.) Investors operate accordingly at their own risk. ）
Reporters | Lin Zichen, Ye Xiaodan, Xu Libo, Chen Xing
Editor| Dong Xingsheng, He Xiaotao, Wang Jiaqi, Du Bo
Proofreader | Sun Zhicheng
| the original article of the daily economic news nbdnews |
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