"Science and Technology Innovation Board Daily" (reporter Gao Mengyang, Ao Jin, Zhu Yanjie) news, the new crown antigen self-test products will soon be directly to the public.
On March 11, the National Health Commission released the news that the Comprehensive Group of the Joint Prevention and Control Mechanism of the State Council in Response to the Novel Coronavirus Pneumonia Epidemic decided to add antigen testing as a supplement to nucleic acid testing, and organized the formulation of the "New Coronavirus Antigen Detection Application Plan (Trial)" (hereinafter referred to as the "Plan").
On March 12, the State Food and Drug Administration issued a notice approving the application change of the self-test application of new crown antigen products in Nanjing Novizan, Beijing Jinwolf, Shenzhen Huada Inyuan, Guangzhou Wanfu Biology and Beijing Huaketai Biology. Since then, five new crown antigen self-test products have been officially launched.
It is worth noting that the "Plan" also clarifies that community residents who have self-testing needs can purchase antigen detection reagents for self-testing through retail pharmacies, online sales platforms and other channels. This means that community residents can purchase antigen detection reagents for self-testing through online and offline channels and stores.
Today (March 13), a reporter from the Science and Technology Innovation Board Daily visited the people's pharmacy in Shanghai, Shenzhen and other cities, and found that the new crown antigen self-test products have not yet been listed. At the same time, online channels such as Meituan, JD.com, Tmall, and Ping An Good Doctor have opened up appointments for the purchase of new crown antigen self-test products.
The offline store has not yet received the product, but has been pre-ordered for multiple boxes
The State Food and Drug Administration announced on March 12 that five new crown antigen self-test products will be approved for listing, as the closest and most convenient channel for the public to buy, retail pharmacies will play an important role.
The reporter of "Science and Technology Innovation Board Daily" learned from a number of stores in Shanghai's people's big pharmacy that the company is internally counting the number of new crown antigen self-test product reservations, and the specific arrival time is expected to be in the middle of next week.
According to the clerk, the pre-sale price of the first batch of new crown self-test products arriving is 596 yuan / box, and the single box of reagents supports 20 people, that is, the unit price is 29.8 yuan / person. In addition, some store personnel said that the first batch of 100 boxes will arrive, and more boxes have been booked.
However, the people's big pharmacy has a store manager said that he will be cautious about stocking, "now basically have a 48-hour negative nucleic acid report, the new crown antigen self-test products are negative and do not recognize, so the follow-up will still look at the customer's demand and then restock, will not enter a lot at once." ”
On the same day, the reporter of the Science and Technology Innovation Board Daily also visited the sales of the first batch of antigen test kits in the stores of Futian, Nanshan and Luohu District of Dashanlin.
The relevant store staff told reporters that at present, only the notice that the product is about to go online, and the store has not yet received the product, "It is expected that it may be a few days later, but the specific time is uncertain." ”
The staff of a store in Nanshan District told the "Science and Technology Innovation Board Daily" reporter that all employees sent a circle of friends about the news that the antigen detection kit will be listed in the store.
She told the "Science and Technology Innovation Board Daily" that after sending out the circle of friends, there were two or three customers who asked for private messages to buy, "Today I also received more than ten phone calls to ask, because now I want to do nucleic acid every day, and some people don't want to go out to do it and want to buy a kit to go back and do it themselves." But she said that it is not yet clear the details of the identification of the self-test results, "but also depends on the follow-up notice on the specific operation." ”
The clerk said that the new coronavirus antigen detection kit produced by Wanfu is currently priced at 386 yuan / box offline, containing 20 reagents, that is, the price of a single test is 19.3 yuan. The reporter inquired about the online mall of Da samlin and found that the product is currently in a state of removal.
In fact, after the release of the "Plan", because the relevant products have not yet officially begun to sell, it has also given some people "opportunities". A few days ago, the Internet circulated information such as the organization of group purchases of Wanfu Biological New Crown Antigen Detection Kit products.
In response to this rumor, Wanfu Bio said on the evening of March 12 that it was found that some individuals and companies did not have the legal authorization of Wanfu Bio to carry out illegal sales publicity through e-commerce and other online channels, in order to avoid the recurrence of such incidents, maintain the normal order of the national fight against the epidemic and the legitimate rights and interests of the company, the company solemnly declared. "Our company implements strict management over the sales of medical device products, and if it is not legally authorized by our company, it is not allowed to sell to the outside world without authorization and carry out false publicity activities." Wanfu Bio said.
Meituan, JD.com, Tmall and other online channels "all in one"
However, on March 13, the reporter of the Science and Technology Innovation Board Daily found that Meituan Buying Medicine has taken the lead in launching the new crown antigen self-test product.
According to the reporter's experience, after landing on the Meituan App or the Meituan takeaway App to enter the drug buying channel, you can search for purchases in the page, in addition to searching for "new crown antigen self-test" or clicking on the "new crown self-test" area in the Meituan drug channel, you can also find related products. Users can perform home self-tests according to the product manual, and the results can be observed in 15-20 minutes.
The relevant page shows that the original price of the new crown antigen self-test products hung up in a pharmacy flagship store was 32.8 yuan / copy, and the delivery status was Nanchang, Jiangxi, and it is expected to be delivered in 1-3 days. According to the detail page, the manufacturer of this kit is Beijing Jinwolf Biotechnology Co., Ltd.
The relevant person in charge of Meituan's drug purchase revealed to the "Science and Technology Innovation Board Daily" reporter that from March 13, users can make an appointment to purchase related products through pharmacies shipped nationwide in the Meituan drug channel, and merchants will use express delivery for users from the 20th.
"Science and Technology Innovation Board Daily" learned that Meituan Buying has joined hands with many chain pharmacies such as the People's Pharmacy, GUODA Pharmacy, Gaoji Medical, Neptune Star, Dashanlin Pharmacy, Quanyuantang Pharmacy, etc., and is expected to launch new crown antigen self-test products synchronously with offline pharmacies within a week to jointly provide the public with 30 minutes of drug delivery service.
In addition to the explicit listing of the US group, Jingdong Health told the "Science and Technology Innovation Board Daily" reporter that it has reached sales cooperation with the first batch of domestic enterprises that have obtained the approval of the "new crown antigen self-test" product of the State Food and Drug Administration. The first batch of new crown antigen self-test products will be opened online reservation at Jingdong Health in the near future.
Tmall Health also revealed to the "Science and Technology Innovation Board Daily" reporter that it has been deeply united with the brand side of the new crown antigen self-test product, and the first batch of products will soon open online pre-sale and debut, and the first time to bring the brand officially authorized antigen self-test products to consumers.
And The Good Doctor of Ping'an (1833. HK) users can make an appointment to purchase the first batch of new crown antigen self-testing agent boxes on the Ping An Health APP, and the platform will also launch the self-testing agent cartridges in the form of specialist service packages at the doctor's workbench, and orders can be purchased after the official sale. For enterprise customers, Ping An Health will rely on the advantages of O2O medical service network to assist enterprise customers in collection.
In addition, the reporter of the Science and Technology Innovation Board Daily learned from the Dingdang Fast Medicine That the company will also launch a "new crown antigen home self-test" 28-minute delivery service to the home. It is reported that Dingdang Fast Medicine 17 cities that have laid out Dingdang Smart Pharmacy have realized antigen detection reagents to be home for 28 minutes through "online ordering store delivery".
Is the new crown antigen testing industry chain ready?
The above-mentioned "Plan" pointed out that nucleic acid testing is still the basis for confirming the diagnosis of the new crown virus, and antigen detection is used as a supplementary means for screening specific populations, which is conducive to improving the ability of "early detection".
The "Plan" proposes that three types of personnel can be tested for antigens:
Persons who go to primary medical and health institutions for treatment, accompanied by respiratory tract, fever and other symptoms and have symptoms within 5 days;
Quarantine and observation personnel, including personnel in home isolation observation, close and sub-close contact, entry isolation observation, sealing and control area and control area;
Residents of communities with antigen self-testing needs.
Compared with nucleic acid detection, antigen detection is faster and more convenient to operate, avoiding the risk of gathering and cross-infection outside the door, and can be completed at home. And some remote basic areas have insufficient nucleic acid detection capacity, which can be alleviated to a certain extent after the promotion of antigen detection related products.
According to the relevant research reports of Huaan Securities, combined with the three types of application scenarios, the market size of the diagnosis and treatment testing demand of grass-roots medical and health institutions is about 5.5 billion yuan, the testing demand of isolation observers is about 2.5 billion yuan, and the self-inspection demand of community residents is about 24.9 billion yuan, with an overall total of more than 30 billion yuan. From a long-term perspective, assuming that after the social opening under the normalization of the new crown, according to the application scenarios of the new crown antigen detection, it is divided into static self-testing and dynamic large-scale detection, and on the whole, the market size of antigen detection is 270 billion yuan.
As of March 13, the State Food and Drug Administration has approved five self-testing new crown antigen testing products in China. However, with the promotion of new crown antigen testing, more manufacturers will enter the track and get product registration certificates in the future. In addition, some domestic companies that have obtained CE certification and US EUA certification are also expected to choose to apply for registration in China.
In terms of the industrial chain, the new crown antigen detection is divided into upstream raw materials, midstream product manufacturing and production, and downstream terminal sales.
It should be noted that in response to the new crown antigen testing products directly facing the public, the State Food and Drug Administration issued a notice on March 12, requiring drug supervision and management departments at all levels to strengthen registration-related management, production supervision and inspection, business supervision and inspection, and severely crack down on violations of laws and regulations.
The State Food and Drug Administration said that during the epidemic prevention and control period, relevant retail pharmacies and enterprises selling new coronavirus antigen detection reagents need to obtain a drug business license or medical device business license and have corresponding storage conditions.
The State Food and Drug Administration requires that all provincial-level drug supervision and management departments should continue to strengthen the monitoring and handling of the network transaction information of the new crown virus detection reagents, and promptly organize the investigation and handling of clues of violations of laws and regulations found by monitoring. Strengthen the supervision and inspection of the third-party platform for medical device network trading services in the jurisdiction, supervise and guide them to strictly perform their obligations such as real-name registration, qualification review, and business behavior management for medical device operators entering the network, and promptly stop and report to the drug supervision and management department when illegal sales of medical devices are discovered.
"Illegal acts such as unauthorized production and operation, production and operation of unregistered new coronavirus antigen testing reagents, etc., should be strictly investigated and dealt with in accordance with the law." Where a crime is suspected, it should be promptly transferred to the public security organs. The above notice of the State Food and Drug Administration is clear.