On February 21, 2022, in the production workshop of a company in Shenzhen, more than 600 workers worked in groups on the assembly line at the same time, rushing to produce rapid test kits for the new crown virus antigen for Hong Kong. (People's Vision/Photo)
Just one weekend later, the new crown antigen test reagent became the focus of everyone's attention.
On March 11, 2022, the "Application Plan for Antigen Detection of the New Coronavirus (Trial)" (hereinafter referred to as the "Plan") was released, and the antigen self-test products were released. On the weekend for two days (12th to 13th), the State Food and Drug Administration intensively approved more than ten new crown antigen detection reagent products, involving 10 manufacturers.
Although the antigen self-test results are only used as a supplement to nucleic acid detection and cannot be independently judged whether the diagnosis is confirmed, this does not affect the sought-after antigen reagent.
Southern Weekend reporter interview found that the new crown antigen detection reagent sales channels are "a box is difficult to find". The sales staff of large chain pharmacies and manufacturers said that there is no stock at present, "waiting for the notice." Among the online sales channels, although Meituan and Tmall have opened official purchase channels, they will be delivered as soon as March 17.
The demand for antigen detection reagents is more urgent for local governments. On March 12, the joint prevention and control mechanism of the State Council held a video conference call to promote the monitoring model of "antigen screening and nucleic acid diagnosis" in view of the transmission characteristics of Omi kerong.
According to the statistics of southern weekend reporters, at least Jilin, Zhejiang, Fujian, Jiangsu and other provinces have been purchased or distributed for antigen testing. Cai Weiping, chief expert of the Infection Disease Center of the Eighth Affiliated Hospital of Guangzhou Medical University, told Southern Weekend that the government will still be the main buyer of antigen detection reagents without changing the existing centralized isolation policy.
Pharmacies are temporarily out of stock, e-commerce companies need to make an appointment, and middlemen want to stock up
On March 12, a screenshot of the circle of friends detonated the medical device industry. In the picture, Hu Hong, secretary of Wanfu Biological Board, sent a laughing cartoon emoji, and said, "The mood at this moment is as follows." After the screenshot was fermented, Hu Hong apologized to the circle of friends at noon on the 13th, saying that the previous emoji was sent due to personal private affairs, and sincerely apologized for not realizing the public's anxiety under the epidemic.
Needless to say, the policy changes are indeed great good news for Wanfu Bio. Wanfu Bio is one of the earliest enterprises approved to produce and sell antigen detection reagents, and was approved by emergency in early November 2020. According to the description of product use, it will only be supplied to professional medical institutions until the release of the "Plan".
On March 12, Guangzhou Wanfu Bioantigen Detection Reagent was approved to change its use from professional medical use only to home self-testing. The other four approved companies are Nanjing Novizan, Beijing Jinwolf, Shenzhen Huada Ingen (a subsidiary of BGI Genomics Holdings) and Beijing Huaketai Biotech.
A market that has been predicted by all parties to be 100 billion is slowly opening to the first batch of 5 lucky people, but for consumers who want to try new testing methods for the first time, it may take a few days.
On March 13, staff at Beijing Neptune Star Pharmacy and NUS Pharmacy told Southern Weekend that there are no antigen detection reagents for sale in the store, and it is impossible to determine when it will be available. In Guangzhou, on March 15, a staff member of the People's Big Pharmacy said that the product was in the process of logistics, the arrival date and the price could not be determined, and the company was still negotiating with 5 other kit manufacturers to supply. Dashenlin Pharmacy said that it will sell reagents from Wanfu Biologics, but it does not know the arrival date for the time being.
The good news is that the day is not far from being able to see antigen tests on pharmacy shelves. On March 13, Yifeng Pharmacy and the People's Pharmacy have issued a document saying that they have reached cooperation with Guangzhou Wanfu Biology and will soon be able to put products on the shelves. On March 14, the Shenzhen store of Dashenlin Pharmacy has received a notice that antigen detection reagents are about to arrive. On the same day, Yixintang also said on the investor interactive platform that the company is actively docking with manufacturers and striving to display sales as soon as possible. The above four are representative enterprises of chain pharmacies.
The faster one is the e-commerce. Southern Weekend reporter found that on the afternoon of March 13, the page information of the Meituan drug purchase showed that there were two test kits of Jinwolf and Wanfu Biology open for pre-sale, and it is expected to be shipped before March 20. One of the platform merchants gave the delivery time is "around March 21", "if you are in a hurry, go to the hospital to do nucleic acid, thank you for your understanding".
On the Jingdong platform, in the results of the search for "new crown antigen detection reagent" on the afternoon of March 13, the first place was still a company that had not yet been approved in China. The product description page has the words "Only sold to Hong Kong, Macao and Taiwan, please contact customer service to verify the order permission before purchasing". On the afternoon of the 14th, the product links between Novizam and Jinwolf were already online on the Jingdong webpage, and only reservations were opened.
The Southern Weekend reporter noted that in addition to the pre-order activities promoted by the e-commerce platform, a small number of stores played the promotion content of "spot and spot". Tmall's page data at noon on March 15 showed that Guorui Pharmacy has sold 33 copies of the "spot" Jinwolf antigen detection kit. But customer service told reporters that it is expected to be shipped within 48 hours.
There are also some middlemen who are active on social media, peddling "sporadic inventory". On March 13, a person claiming to be a distributor of Wanfu Biology quoted to the Southern Weekend reporter: a box of 20 bottles of Wanfu antigen detection reagents asked for 500 yuan, if you buy a full box (30 boxes) at a time, each box can be reduced to 400 yuan.
In the two days of March 13 and 14, the dealer sent more than 20 circles of friends. She said that the phones have been "exploded" and dealers are currently queuing up to pick up the goods. In two days, she got 6 boxes of goods each, but only intends to sell two boxes on the 14th - aiming to cope with the subsequent possible market rise in the form of hoarding.
The day is not far from being able to see antigen tests on pharmacy shelves. (People's Vision/Photo)
Manufacturers are also short of spot, and the government has become the main buyer
It is not only pharmacies and e-commerce that are out of stock. Southern Weekend reporters consulted the sales staff of many manufacturers in the name of corporate procurement and learned that there is no spot in the direct sales channels of manufacturers at present.
On March 13, a sales staff of Beijing Huaketai Biology told the Southern Weekend reporter that there is no antigen detection reagent in hand at present, and it is necessary to clearly place an order from the customer, pay the contract and then schedule it, and the earliest delivery period has been scheduled to this Saturday (March 19).
The sales staff of Nanjing Nuoweizan and Beijing Jinwolf also told the Southern Weekend reporter that it is currently impossible to supply reagents in stock, and can only wait for shipment after booking. Nanjing Nuoweizan sales staff said that the fastest will not be until this Thursday (March 17) to determine whether there is a stock. The Sales staff at Jinwolf in Beijing said that it needs to be shipped in the order of payment, "it may take 7-10 days, it may be faster."
The sales staff of Beijing Huaketai Bio revealed that the orders received by the company at present are mostly from government departments. Among the public information channels, there is no news of a large amount of government orders from Beijing Huaketai. However, several local governments have announced their own procurement plans.
On March 14, Song Xiaohui, deputy director of the Department of Industry and Information Technology of Jilin Province, said at the press conference that the Department of Industry and Information Technology of Jilin Province, through the National Health Commission and other channels, urgently communicated with antigen reagent manufacturers such as Beijing Heatscape Biology and Guangzhou Wanfu Biology, and ordered 12 million antigen detection reagents nationwide in a short period of time. According to data from the National Health Commission, on March 14, there were 3,507 new locally confirmed cases nationwide, of which Jilin accounted for 3,076 cases.
For the current severe epidemic prevention situation, antigen testing is placed on high hopes to improve the efficiency of screening. On March 13, Sun Chunlan, vice premier of the State Council, stressed during his investigation and guidance of epidemic prevention and control in Jilin that it is necessary to speed up the screening of infected people and adopt a combination of nucleic acid and antigen detection.
A common point of emergency procurement and distribution of antigen detection reagents in various places is that at the moment of shortage of spot, it relies on local manufacturers to supply. On March 14, the first batch of new coronavirus antigen test kits in Nanjing, Jiangsu Province, completed the procurement and distribution of 1.25 million copies, and will be distributed to primary and secondary schools in the city. This batch of products is from Nanjing Nuoweizan; the antigen kit supplied by Xiamen, Fujian Province, is from Xiamen Anbang Biologics; and the antigenic kits distributed in Hangzhou, Zhejiang Are also from the local Botuo Biologics, Laihe Biologics.
It is worth noting that the antigen kits of Botuo Biology, Laihe Biology have not yet been approved for sale in China, so the donation model is adopted. On March 14, Botuo Bio responded to the outside world that the kits were donated to fight the epidemic at the request of the government and the epidemic prevention office, not a sales act. Laihe Bio-1 staff told southern weekend reporters that the company, at the request of the Zhejiang Provincial and Hangzhou Municipal Health Commission, donated a batch of reagents to the shangcheng district free of charge to support the prevention and control of the epidemic.
Those who have been approved are in a hurry to expand production, and those who are waiting for approval are busy with approval
The first 5 companies to enter the market have a first-mover advantage. Now, they choose to actively expand production in order to seize this huge "virgin land".
The sales staff of the above-mentioned Beijing Huaketai Bio said that the company did not get the news of the release of antigen self-testing in advance, so there was no large number of stockpiles. "It hasn't been done too much before, and the daily output may be 300,000 people." Since receiving this notice, it has actively expanded production. ”
Also announcing the expansion was Kinvolv. On March 12, Beijing Jinwolf Biological staff revealed in an interview with the media that there are currently 10 million orders, and the company will increase the production capacity of antigen detection kits to 1.7 million copies per day. 2,000 workers, working in two shifts, to meet the domestic market demand with maximum production capacity.
Enterprises that have been approved for listing are busy increasing production, and manufacturers that have not yet been approved are concerned about whether they can get certificates as soon as possible and participate in a piece of cake.
Xie Muqing, an analyst at Zhongtai Securities, said in a research report published on March 6 that if the new crown antigen detection reagent enters the special review procedure for innovative medical devices or the priority approval procedure for medical devices, it is expected that the approval time may take 3-12 months. If the three types of registration certificates are declared according to conventional in vitro diagnostic reagents, the entire approval process may take 1 to 3 years.
Earlier, Cai Weiping also told the Southern Weekend reporter that when companies that have been listed overseas products submit reviews in China, they can use existing clinical trial data and review materials to occupy a certain advantage.
Southern Weekend statistics found that a total of 6 enterprises were approved after the release of the "Plan" on March 11. In addition to Tianjin Boossais, the other 5 enterprises - Nanjing Nuoweizan, Beijing Heatscape, Beijing Wantai, Chongqing Mingdao Jie test, Beijing Lepu antigen self-test products have obtained the EU CE certificate, which means that they can be sold in the European market.
For those who break through the barriers, the domestic review threshold is rising sharply. On March 14, the Instrument Review Center of the State Food and Drug Administration organized and formulated the "Key Points for technical review of the registration of new coronavirus antigen detection reagents (trial)" and other technical review points. It is mentioned that different viral load samples in the positive samples of clinical trials should have sufficient sample sizes: taking the positive judgment value of the nucleic acid detection reagent Ct≤38 as an example, it is recommended that the number of positive samples with a Ct value of ≤30 should not be less than 170, and the number of positive samples with a Ct value of >30 should not be less than 30. Referring to the clinical data of Chinese products currently approved in the EU, it can be found that most manufacturers cannot meet this requirement.
In fact, companies gamble on COVID-19 antigen testing reagents, mainly looking at the huge potential market in China. Tan Guochao, chief analyst of Huaan Securities, proposed in the research report that under the long-term perspective, assuming that the penetration rate of antigen detection can reach 80% of the reference vaccination rate, according to the country's 1.4 billion people tested twice a month, the terminal retail price of 10 yuan / person to calculate, only the self-test market size can reach 268.8 billion yuan per year.
According to regulations, there are currently three application scenarios for antigen detection reagents, namely, medical and health institutions at the grass-roots level, self-testing by isolation observers, and antigen self-testing needs of community residents. The first two types of scenarios are expected to be mainly government procurement, and the third type of scenarios are expected to be mainly self-funded.
Obviously, at a time when the epidemic has not yet spread in a large area, confirmed cases still have to be centralized isolation and nucleic acid testing is used as the "gold standard", the willingness of ordinary residents to pay for testing is still limited, and the orders generated by the government to carry out large-scale screening will still occupy the majority of the antigen testing market.
At the current approval rate, there may be more antigen detection products to meet with consumers in the future. Southern Weekend reporters found that as of March 15, including Mingde Biological, Jiuan Medical, Saili Medical and other enterprises have publicly stated that they have submitted applications for approval of antigen testing products to the Chinese drug review agency.
On March 3, 2022, in Hong Kong, staff packed a rapid test kit for antigens for the new crown virus. (People's Vision/Photo)
Collect the cost of mining, the price will go down
As more players enter the track, the price of antigen detection is expected to come down through market competition.
In fact, the single antigen detection reagent on the e-commerce platform is currently highly quoted. On March 13, the single-person testing products of Jinwolf and Wanfu Bio found by Southern Weekend reporters on the Meituan platform asked for 32.8 yuan and 29.8 yuan respectively. On March 14, the same Wanfu biological products also rose to 32.8 yuan.
For medical institutions and governments that place orders, it is not the retail price that needs to be considered, but the collection price. Previously, the "Plan" has clearly proposed to continuously reduce the price of detection reagents through provincial centralized recruitment.
In contrast, it can be found that the terminal price of the products of the manufacturers that have gone abroad has been depressed, and even slightly lower than the price of the domestic e-commerce platform. Taking Heatscape Bio's 5-pack antigen detection product as an example, its price on the German Amazon website with postage is 14.4 euros, about 100 yuan, while the minimum price of the Tmall platform is 106 yuan. For manufacturers, after a large number of entrants into the domestic market, profits may be diluted due to collection, but it is still profitable.
In the procurement of new crown virus detection reagents in 11 provinces in May 2021, Wanfu Bio became the only winning bidder with an offer of 16.8 yuan. After this, the quotations of companies that are not shortlisted are also moving closer to this price line. In the process of inquiring on March 13, Beijing Huaketai, Jinwolf and Novizon reported the purchase prices to the Southern Weekend reporter of 13 yuan, 13 yuan and 15 yuan per person, respectively.
Compared with the price of nucleic acid and antibody detection reagents, the price of antigen detection reagents of 10-15 yuan still has room to explore.
A comparison is that in the Procurement of the Beijing-Tianjin-Hebei-Lu Alliance in August 2021, the minimum winning price of nucleic acid detection reagents was 5.38 yuan, and the minimum winning price of antibody detection reagents was 3.5 yuan. In general understanding, the low cost is the advantage of antigen detection over nucleic acid detection.
It is foreseeable that as the market becomes larger and the number of manufacturers increases, the next round of collection will further reduce the price of new crown antigen detection reagents. On March 14, the Tianjin Pharmaceutical Procurement Center issued a notice saying that it would carry out centralized maintenance of product information for the new coronavirus antigen detection reagent. Since the Tianjin Pharmaceutical Procurement Center has been responsible for the implementation of the national collection of high-value consumables, this notice is also regarded by the industry as a signal that the new crown antigen detection reagent is about to start a quantity procurement.
(Southern Weekend reporter Mai Circle also contributed to this article)
Southern Weekend reporter Haiyang Southern Weekend intern Huang Jiayu