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Original title: The new crown self-test has been approved to promote concept stocks, and the 100 billion market is to be divided up?
Listed companies that have been approved to produce new crown self-test kits have been sought after by the market for a while. Take the new crown detection sector as an example, which has performed well recently.
Article | Caijing reporter Yang Xiuhong Wang Ying
Editor | Lu Ling
Under the severe epidemic situation, the domestic new crown antigen self-test kit was approved for marketing. As of March 15, the State Food and Drug Administration has approved the registration applications of 10 new crown antigen products. These products involve a number of listed companies.
A reporter from Caijing noticed that some new crown antigen self-test products were sold out as soon as they went online. At present, most of the products launched on major e-commerce platforms are pre-sale products.
Affected by the above news, listed companies that have been approved to produce new crown self-test kits have been sought after by the market for a while. Take the COVID-19 testing sector as an example, the sector has performed well recently, with many individual stocks increasing by 20% in a single day, and one stock’s increase has nearly doubled.
“In the short term, the launch of the new crown self-testing product will be beneficial to related companies.” Zeng Wanping, the macro strategy team leader of Huiquan Fund, told the Caijing reporter, “However, there are currently many participating companies, which will not benefit a certain company and benefit. The company is more fragmented.”
A number of securities companies have released research reports that the new crown testing market is expected to reach the level of 100 billion.
A senior industry insider told the Caijing reporter, “Under the current epidemic situation, the performance of new crown testing concept stocks is expected to continue to outperform the market.”
New crown self-test approved to stir concept stocks
The epidemic situation is severe, as a supplement to nucleic acid testing, the new crown antigen self-test product was quickly approved for marketing.
From March 12th to 13th, the State Food and Drug Administration issued a series of circulars, approving the registration applications of new crown antigen self-test products of many companies.Up to now, 10 new crown antigen self-test products have been officially approved, and the approved companies include NanjingNorwegianBeijing Jinwofu, Shenzhen Huada Yinyuan, GuangzhouWanfu BioBeijing Huaketai Biological and so on.
On the evening of March 13th,BGI(300676.SZ), Novozymes (688105.SH), Wanfu Biological (300482.SZ) and other listed companies disclosed announcements, indicating that their new crown antigen detection products have completed the intended use of medical device product registration, increased sample types and instructions. changes.otherwiseMatilda Bio(002932.SZ) said that the company’s new crown antigen detection reagent has submitted a registration application to the State Drug Administration.
Caijing reporter noticed that on March 14, many e-commerce platforms have launched new crown self-test products. One of the 498 yuan a box (for 25 people) of the new crown antigen self-test product was sold out as soon as it was launched on an e-commerce platform.
At present, most of the new crown antigen self-test products on these e-commerce platforms are pre-sale products and will not be shipped until March 20.
Demand from affected areas is also evident. On the afternoon of March 14, Song Xiaohui, deputy director of the Jilin Provincial Department of Industry and Information Technology, said at a press conference on the prevention and control of the new crown epidemic in Jilin Province that Jilin Province had ordered 12 million antigen detection reagents nationwide in a short period of time.
Affected by the above news, the trend of the new crown detection sector was significantly stronger than the market. On March 14, the sector bucked the trend and strengthened, becoming one of the most dazzling sectors that day.The next day, although the sector has pulled back, it is still relatively resilient.Lanwei Medicine(301060.SZ) hit three daily limits in four days, with an increase of 94.75%.
It is reported that although the company is not the production company of the recently approved new crown antigen self-test products, but relying on its own accumulation, its many laboratories are among the first local institutions to be approved for new crown virus testing.
In addition to the above-mentioned companies whose self-test products have been approved for listing in China, several A-share listed companies have recently disclosed in announcements and investor interaction platforms that they have obtained the listing qualifications for overseas new crown antigen detection reagents.
The stock price has risen more than 11 times in two monthsJiu’an Medical(002432.SZ), once disclosed the announcement in November last year that “the new crown antigen home self-test OTC kit has obtained the authorization for emergency use in the United States”, and the stock price has since activated the upward switch.
FurthermoreDean Diagnostics（300244.SZ）、Shengxiang Biological（688289.SH）、Mike Bio(300463.SZ), Mingde Bio,Yuyue Medical（002223.SZ）、Lepu Medical（300003.SZ）、Minovar（603538.SH）、Leizhi Group(002398.SZ) and more than a dozen companies released the latest progress of their overseas new crown antigen self-test products.
In addition to manufacturers, on the sales side of test boxes, chain pharmacy leaders and e-commerce platforms have also moved quickly to join the product distribution race.
includecommon people（603883.SH）、Daisanrin(603233.SH), Guoda Pharmacy and other chain pharmacies, as well as pharmaceutical e-commerce platforms such as Gaoji Health, Ali Health, and Ping An Good Doctor (01833.HK) announced that they have reached cooperation with approved manufacturers, and self-tested products will be On sale.
Institutions expect the market size to reach 100 billion
After being certified by the official “seal”, the antigen detection as a nucleic acid detection assistant has high expectations.
In the past, nucleic acid testing was mainly used in China, while overseas new crown testing was mainly based on antigen testing. Next, with the large-scale implementation of antigen detection products, there will be huge demand for consumption. How big will the market size of this segment be in the future?
Some market participants said that it depends on the price and frequency of use of new crown antigen detection products. A number of institutions have released research reports that the annual market size is expected to reach 100 billion.
Zhongtai SecuritiesIn the research report, it is pointed out that with reference to overseas distribution policies, the distribution frequency of overseas new crown antigen self-test kits varies significantly, ranging from 2-10 times per capita. At present, the ex-factory unit price of domestic new crown antigen self-test kits is about 1-1.5 US dollars. If domestic antigen self-test kits are officially released, with reference to overseas policies, the minimum frequency is assumed to be twice a month. It is estimated that the domestic new crown antigen self-test kit market is a month The scale is expected to reach 17.7 billion-26.6 billion yuan. According to this calculation, the annual market size may exceed 200 billion yuan.
Tianfeng SecuritiesIt is believed that the new crown antigen test may become an important supplementary means of epidemic prevention and control in China. The main reasons are: domestic antigen test products are mature, and the sensitivity can reach 90%; European antigen test has been implemented for more than a year, and the epidemic prevention and control has been verified; The product capacity is sufficient to supply. In 2021, China will export a total of 66.893 billion yuan of new crown detection kits overseas, and the cycle for companies to expand production is relatively short.
However, the market size of the new crown antigen detection products is different from the research and judgment of most institutions. Some medical professionals told Caijing reporters that the prospects are very good, but the market is limited. , because the antigen self-test results are not recognized by government departments and cannot be used as travel vouchers, and now there are 8-10 yuan nucleic acid mixed testing and 35-40 yuan nucleic acid individual testing, which are also recognized by government departments, why spend more Do you have to go to your own home for a test?”
He also said that antigen self-testing has a large market in Europe and the United States and other regions, because the government’s unfavorable control of the epidemic has led to widespread infection of the new coronavirus and its mutated viruses. When the government is unable to fight the epidemic, people need to self-check at home in order to save themselves, but the domestic self-check market will not be too big, especially when free nucleic acid testing is launched in some areas.
Due to the large number of manufacturers, the competition in the self-testing market for COVID-19 will be more intense in the future.
It is understood that there are not many manufacturers that actually produce antigen detection kits in China. Most companies had previously targeted overseas markets.
According to Zhongtai Securities, hundreds of domestic in-vitro diagnostic manufacturers have registered and approved the new crown antigen self-test kits overseas. According to statistics from the General Administration of Customs of China, China’s total export volume of new crown antigen testing products in 2021 is 71.4 billion yuan. According to Tianfeng Securities, there are currently 94 Chinese antigen testing products certified by the EU CE certification, 3 products in the US EUA, and many new crown antigen testing products.
Why are the reagent products of most listed companies not certified in China, and the threshold for domestic listing is high? “It’s not high, mainly because the market is abroad, and the company knows it very well, so take the foreign one first.” The aforementioned medical person told the Caijing reporter.
Zhongtai Securities said that with reference to the registration and approval of domestic in vitro diagnostic kits, it believes that the domestic new crown antigen self-test kits have entered the market.innovative medicalFor the special device review process or the medical device priority approval process, it is estimated that the approval time will take 3-12 months; if the third-class registration certificate is applied for conventional in vitro diagnostic reagents, the entire approval process may take 1-3 years.
It is worth noting that antigen self-test results cannot replace nucleic acid reports. Nucleic acid testing is still the gold standard for judging new crown infections, and antigen testing is still a “supporting role”.
Wanfu Bio also stated that the new coronavirus antigen detection kit (colloidal gold method) product developed by the company cannot 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. Infection status. Jiu’an Medical also admitted at the investor event that the sensitivity of the home self-test kit is lower than that of nucleic acid detection, and this product can be used as a self-screening tool.
Judging from the current price of antigen detection products, according to the ex-factory unit price in the aforementioned Zhongtai Securities research report and the exchange rate on March 15, the ex-factory unit price is about 6.38-9.57 yuan. However, from retail terminals such as Meituan and Taobao, antigen detection products are about 20-35 yuan per piece. According to an internal group buying group of a brokerage, the Wanfu biological antigen self-test kit is 12 yuan per person.
“The price of 20-35 yuan is for consumer terminals, and it is normal to have a relatively large gap with the wholesale price. As the production of products increases in the domestic market, the price is expected to decline.” Some medical investors said. The aforementioned medical professionals believe that the ex-factory price will not be too high, and the retail price is indeed high.
So how do domestic product prices compare with overseas ones? Jiu’an Medical disclosed that the selling price of its antigen detection kit products on the official website of the United States is $6.99 (excluding shipping), and $9.99 after shipping.
In fact, some citizens have recently obtained free self-test products distributed. On the evening of March 11, a resident of Haicang District, Xiamen City posted on a social platform that they had received an antigen detection kit distributed free of charge by the community, and the product packaging was displayed in a foreign language. On the evening of March 13, some Hangzhou residents received a letter from a listed company.Boto Bio(688767.SH) and the new crown antigen detection reagents produced by Hangzhou Laihe Biotechnology Co., Ltd., both of which are local enterprises in Hangzhou.
(Reporter Liu Zonggen of Caijing also contributed to this article)
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