On March 13, the State Food and Drug Administration approved the registration application of five covid-19 antigen products.
Since then, a total of 10 covid-19 antigen self-test products have been officially launched
previously reported
Swipe the screen on weekends! Covid-19 antigen self test is about to appear on the market. Emergency statement of 20 billion giants! Who will be on the next list? Which companies benefit most?
This weekend, covid-19 antigen detection reagent became the hottest topic in the market.
Covid-19 antigen detection reagent has become the focus of the market at the time of its launch. At noon on March 13, it was reported that the first batch of covid-19 antigen rapid test products distributed by Lbx Pharmacy Chain Joint Stock Company(603883) pharmacy in Guangzhou Guangzhou Wondfo Biotech Co.Ltd(300482) are expected to be put on sale online and offline from the morning of March 14. However, later, some media reported that the antigen detection reagents distributed by Lbx Pharmacy Chain Joint Stock Company(603883) may be put off the shelves or need to supplement relevant qualifications.
retail price is also a hot topic in the market. The Chinese reporter of the securities firm saw on the meituan takeout app that covid-19 antigen detection kit has been put on the shelves in some pharmacies. The price of the product is 32.8 yuan / copy. It is currently in pre-sale status and is expected to be delivered on the 20th. The specific delivery time of / store has not been determined by the media, and the specific delivery time is about 30 yuan / store
According to the latest notice issued by the State Food and drug administration, the application for change of covid-19 antigen product self-test application of Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) , Beijing jinwofu, Shenzhen Huada Yinyuan, Guangzhou Guangzhou Wondfo Biotech Co.Ltd(300482) , Beijing huaketai biology was approved. This means that the five companies will probably seize the opportunity or take the lead in selling on the shelves. Among them, Guangzhou Wondfo Biotech Co.Ltd(300482) , Shenzhen Huada Yinyuan ( Bgi Genomics Co.Ltd(300676) ) and Nanjing Vazyme Biotech Co.Ltd(688105) are A-share companies.
According to incomplete statistics, there are at least 20 or 30 A-share companies producing antigen self-test reagents. Then, which companies will approve antigen self-test reagents will become the focus of the market.
covid-19 antigen products will be on sale soon
A document of the National Health Commission makes covid-19 antigen detection reagent one of the most concerned focuses in the A-share market.
Who will take the lead? When will covid-19 antigen detection reagent go on sale? What's the price? It has become a hot topic in the market.
On March 12, the State Food and Drug Administration issued a notice approving the change of covid-19 antigen product self-test application of Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) , Beijing jinwofu, Shenzhen Huada Yinyuan, Guangzhou Guangzhou Wondfo Biotech Co.Ltd(300482) , Beijing huaketai biology.
This means that these five companies will probably take the lead, and the above five covid-19 antigen products may be the first to be put on the shelves. Among them, Guangzhou Wondfo Biotech Co.Ltd(300482) , Shenzhen Huada Yinyuan ( Bgi Genomics Co.Ltd(300676) ) and Nanjing Vazyme Biotech Co.Ltd(688105) are A-share companies.
On March 13, it was reported that the first batch of covid-19 antigen rapid test products distributed by Lbx Pharmacy Chain Joint Stock Company(603883) pharmacy in Guangzhou Guangzhou Wondfo Biotech Co.Ltd(300482) are expected to be put on sale online and offline from the morning of March 14.
But then, China business reported that the antigen detection reagents distributed by Lbx Pharmacy Chain Joint Stock Company(603883) may be put off the shelves Lbx Pharmacy Chain Joint Stock Company(603883) replied that at present, the covid-19 antigen self-test products of Guangzhou Wondfo Biotech Co.Ltd(300482) are still in the warehouse of Hunan headquarters, and the pharmacy in Shanghai needs to create a new directory and the approval of the superior before they can be put into storage; Some pharmacies also need to apply for the qualification of selling this product, which is expected to take another two weeks to put on the shelves.
In addition, some insiders told the media that Guangzhou Wondfo Biotech Co.Ltd(300482) because there is no manual for replacing antigen detection reagent, it has been required to be temporarily removed from the OTC channel and put on the shelf again after replacing the product manual.
another large chain drugstore - Dashenlin Pharmaceutical Group Co.Ltd(603233) the salesperson said that at present, he only received the notice that the product will be launched soon. The specific time point is to be determined. The product has not been delivered yet, and it may take a few days
Under the large-scale expectation of covid-19 antigen detection products, the funds of market institutions have already entered the site in advance. On March 11, covid-19 detection, covid-19 drugs and other anti epidemic theme sectors of A-Shares set off a wave of daily limit, Shanghai Labway Clinical Laboratory Co.Ltd(301060) , Hangzhou Biotest Biotech Co.Ltd(688767) , Hangzhou Alltest Biotech Co.Ltd(688606) , Shenzhen Yhlo Biotech Co.Ltd(688575) , Guangzhou Wondfo Biotech Co.Ltd(300482) all gained 20cm daily limit, Andon Health Co.Ltd(002432) , Saili medical and other more than 20 shares.
chain drugstores also rose sharply. The share prices of Lbx Pharmacy Chain Joint Stock Company(603883) , Dashenlin Pharmaceutical Group Co.Ltd(603233) and Dashenlin Pharmaceutical Group Co.Ltd(603233) rose by 6.8% and 9.77% respectively, and their total market values rose to 17.68 billion yuan and 26.84 billion yuan respectively
In the face of this wave of tuyere, someone tried to "rush" sales in violation of regulations. In March 12th, Guangzhou Wondfo Biotech Co.Ltd(300482) issued a statement that recently, the New Coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) developed by the company has changed the approval documents of medical devices. It has been found that some individuals and companies have illegally sold and publicized through electricity providers and other online channels without the legitimate authorization of our company.
Guangzhou Wondfo Biotech Co.Ltd(300482) expresses that, for the individuals and companies that have not authorized the company, authorized to pass the electricity supplier and other online channels without authorization, and have claimed the products of New Coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) developed by the sales company, Guangzhou Wondfo Biotech Co.Ltd(300482) reserves the right to report to the relevant public security departments and investigate the corresponding legal liabilities.
market space
At present, another concern of the market is, what will be the retail price of covid-19 antigen detection reagent in China?
On March 13, the Chinese reporter of the securities firm saw on the meituan takeout app that covid-19 antigen detection kit has been put on the shelves in some pharmacies, but it is for pre-sale. It is expected to be delivered on the 20th. The pre-sale price of the product is 32.8 yuan for one person and 498 yuan for 25 people. The manufacturer of the kit is Beijing jinwofu.
In addition, according to the report of surging news on March 13, Lbx Pharmacy Chain Joint Stock Company(603883) pharmacy staff said that at present, covid-19 antigen self-test products can not be purchased, so we need to register and make an appointment first. The specific arrival time has not been determined. The store has only 100 boxes in the first batch, the price is 596 yuan / 20 pieces, and the price of a single piece is about 30 yuan / piece.
According to media reports, Beijing jinwofu biological staff said that in addition to international orders, the company will fully produce and supply Chinese orders, increase the production capacity of antigen detection kit to 1.7 million copies / day, and guide the retail price to be lower than the nucleic acid detection price of 50 yuan / person.
It is reported that covid-19 antigen detection products are divided into POC professional version (hospital use) and household self-test, and their prices are different. According to the person in charge of the pharmaceutical e-commerce platform, Guangzhou Wondfo Biotech Co.Ltd(300482) covid-19 antigen self-test product has a winning price of 16.8 yuan / piece in the hospital, and the price of the retail platform should rise to a certain extent. Dashenlin Pharmaceutical Group Co.Ltd(603233) store staff revealed that New Coronavirus's New Coronavirus antigen detection kit was priced at 386 yuan / box, containing 20 reagents, that is, the price of a single test was 19.3 yuan.
referring to the western market, among covid-19 antigen detection reagents, household self-test accounts for a relatively high proportion, and the market space is broader. If calculated according to the retail price of 20-30 yuan / piece, what will the Chinese market scale of covid-19 antigen self-test products reach
Zhongtai Securities Co.Ltd(600918) in the research report, referring to the overseas distribution policy, the distribution frequency of overseas covid-19 antigen self-test kit varies significantly, ranging from 2 to 10 times per capita. If China's antigen self-test kit is officially released, referring to the overseas policy, it is assumed that it is distributed twice per capita per month according to the minimum frequency. Based on this calculation, the terminal retail market scale of covid-19 antigen self-test reagent products in China may reach 56-84 billion yuan / month.
However, insiders pointed out that if the covid-19 antigen detection method is rolled out in China in the future and the demand in the Chinese market increases, the possibility of centralized procurement of national medical insurance cannot be ruled out. At that time, the price of covid-19 antigen products will be subject to bidding, and the final ex factory price may be greatly reduced.
listed companies have stated their position
Although there are only five companies and five products in the first batch of the list of the State Food and drug administration, in the face of the upcoming opening of China's incremental market, other players are naturally unwilling to lag behind, and the probability will be actively declared.
At present, covid-19 antigen self-test kits from hundreds of in vitro diagnostic manufacturers in China have been registered and approved overseas, and the market competition in Europe, Malaysia and other regions is becoming increasingly fierce, making the product price more market-oriented.
Some analysts believe that with the launch of covid-19 antigen products in the Chinese market, the number of enterprises approved for listing in China will gradually increase.
In fact, at the first time after the National Health Commission issued the application scheme for covid-19 virus antigen detection (Trial), Andon Health Co.Ltd(002432) said that covid-19 virus antigen detection products will be used as medical devices and can be listed in China only after being approved by the drug evaluation center (CDE) of the State Food and drug administration. As for the purchase method, there may be government centralized purchase, personal pharmacy purchase and online purchase.
At the end of last year, the official website of the China Meheco Group Co.Ltd(600056) health products import and Export Chamber updated the list of medical materials manufacturers that obtained foreign standard certification or registration. New Coronavirus test reagent added Andon Health Co.Ltd(002432) , Bihan bio and Zhejiang Orient Gene Biotech Co.Ltd(688298) were registered by the US EUA.
Since the last two days, there have been more and more questions about covid-19 antigen detection reagent on the A-share investor interaction platform, and listed companies have also expressed their positions on the platform.
On March 11, Zhejiang Orient Gene Biotech Co.Ltd(688298) announced that up to now, the company's covid-19 antigen detection reagent has not obtained the Chinese certification, and the company will fulfill the obligation of announcement after obtaining the certificate. Although Zhejiang Orient Gene Biotech Co.Ltd(688298) said that it had not obtained the Chinese certification certificate, Zhejiang Orient Gene Biotech Co.Ltd(688298) as one of the earliest enterprises in China to develop covid-19 antigen rapid detection technology, it is the first enterprise in China to obtain the CE certification for covid-19 antigen rapid diagnosis.
On the same day, Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) announced that the company's covid-19 antigen detection reagent had submitted an application for registration to the State Drug Administration, and the time of obtaining the registration certificate was still uncertain.
Jiangsu Yuyue Medical Equipment And Supply Co.Ltd(002223) said that the covid-19 antigen detection products independently developed by the company are divided into hospital version and home self-test version. Among them, the hospital version has passed the CE certification, the EU CE certification of home self-test version and the FDA emergency use authorization (EUA) company are still actively promoting, and the company will closely track the relevant market conditions at home and abroad, Actively layout and promote business development.
Dian Diagnostics Group Co.Ltd(300244) said that covid-19 virus antigen detection kit is mainly sold in Germany, Austria and other European countries, and has also been sold in Hong Kong.
Sansure Biotech Inc(688289) recently said on the interactive platform that covid-19 antigen detection products that can be used for home self-test have applied for EU CE certification and US FDA certification, which will further provide diversified identification and detection schemes for international epidemic prevention and control and improve the comprehensive competitiveness of the company's products.
Lets Holdings Group Co.Ltd(002398) also said that the average daily production capacity of the joint-stock company Aode biological covid-19 virus antigen detection reagent is about 3 million copies. At present, the products are mainly sold to the German market. (source: China securities firm)
extended reading
Pre sale 32.8 yuan! Antigen self-test products will be listed in a number of a shares! The food and Drug Administration issued a document to strictly investigate the production and operation without permission!
Covid-19 antigen self-test product was approved on the first day of listing: several boxes of pharmaceutical e-commerce had been booked in the store
