As more and more enterprises join the competition, the price of covid-19 antigen self-test products in the mainland may usher in a new round of price reduction.
In March 12th, the State Food and Drug Administration announced the approval of the "COVID-19 virus antigen detection application plan" (hereinafter referred to as the "plan") by the State Council to respond to the joint prevention and control mechanism of New Coronavirus pneumonia outbreak. It was approved by the State Administration of food and Drug Administration of Nanjing, Beijing, Guangzhou, Shenzhen, Guangzhou Wondfo Biotech Co.Ltd(300482) and Shenzhen. Application for change of self-test application of covid-19 antigen detection kit of Beijing huaketai biology.
This means that the first five covid-19 antigen self-test products were officially launched. Before that, there was no covid-19 virus rapid detection product approved by the State Food and Drug Administration in the mainland for home self-test. The State Food and drug administration has only approved four covid-19 antigen detection products for medical institutions, which are from Guangzhou Guangzhou Wondfo Biotech Co.Ltd(300482) , Beijing jinwofu, Shenzhen Huada Yinyuan and Beijing huaketai biology. The above four products need to be used by professionals in an environment that ensures biosafety and meets the use conditions.
According to the plan, community residents who need self-test can purchase antigen test reagents for self-test through retail pharmacies, online sales platforms and other channels. According to a covid-19 antigen detection kit project document obtained by times finance, the previous registration information of relevant products indicated that "the product should be used by professionally trained personnel in an environment that ensures biosafety and meets the use conditions", that is, the product can only be used in the scene of medical institutions. After the registration information is changed, The description of the product use environment has been changed to "follow the relevant national regulations such as the scheme".
Although there is no clear indication that the product can be used for personal self-test, people in the industry generally believe that this means that the scope of application of antigen detection reagent products is expanded and allowed to be used in personal self-test and other scenes, and the test results can be obtained in 10 ~ 15 minutes at the fastest.
On March 12, times finance repeatedly called the Sales Department of the above-mentioned related enterprises, but they all showed that they were "on the phone". As a purchaser, times finance learned from a salesperson of Guangzhou Wondfo Biotech Co.Ltd(300482) ( Guangzhou Wondfo Biotech Co.Ltd(300482) . SZ) that the company is currently deploying products to be sold in retail pharmacies, and the external sales price has not been determined. It is expected to be available in pharmacies next week or next week.
According to media reports on March 12, Dashenlin Pharmaceutical Group Co.Ltd(603233) ( Dashenlin Pharmaceutical Group Co.Ltd(603233) . SH) and Guangzhou Wondfo Biotech Co.Ltd(300482) have signed a strategic cooperation agreement on the distribution of covid-19 antigen self-test reagent, and Guangzhou Wondfo Biotech Co.Ltd(300482) covid-19 antigen self-test reagent will be "launched" in Dashenlin Pharmaceutical Group Co.Ltd(603233) offline stores tomorrow (March 13).
price war is about to start
Covid-19 antigen detection kit is not new. As early as 2020, China had a covid-19 antigen kit approved for marketing. However, due to China's good epidemic control and strong nucleic acid detection ability, covid-19 antigen detection is far less frequently used than nucleic acid detection.
However, compared with nucleic acid detection, antigen detection has the advantages of convenient use and low cost Southwest Securities Co.Ltd(600369) points out that the cost of nucleic acid amplification test is as high as US $75 ~ 100 each time, while the cost of antigen test is only US $5 ~ 50 each time.
With the advantage of centralized purchase and price reduction, the price of antigen detection in the mainland is likely to become a "price depression" in the world again, just like that of nucleic acid detection.
On May 21, 2021, Guangdong Pharmaceutical Trading Center announced the winning price information of covid-19 virus detection reagent alliance regional group procurement with quantity, and a total of 11 provinces and cities participated in the centralized procurement. Among them, Guangzhou Wondfo Biotech Co.Ltd(300482) won the bid exclusively in the antigen detection reagent group, and the bid winning price was 16.8 yuan / person.
Shidai finance and economics learned that the ex factory price of Guangzhou Wondfo Biotech Co.Ltd(300482) covid-19 antigen detection reagent is about 13 yuan / person, and the external price is still subject to the price selected in centralized purchase. However, the quotation of in vitro diagnostic reagent dealers has reached 405 yuan / box, 20 people per box, about 20 yuan / person.
According to statistics, there are more than 30 enterprises with covid-19 antigen self-test products approved overseas but not approved by the State Food and drug administration, including Andon Health Co.Ltd(002432) ( Andon Health Co.Ltd(002432) . SZ), Beijing Hotgen Biotech Co.Ltd(688068) ( Beijing Hotgen Biotech Co.Ltd(688068) . SH), Shenzhen Yhlo Biotech Co.Ltd(688575) ( Shenzhen Yhlo Biotech Co.Ltd(688575) . SH) and other enterprises with excellent performance in the export market.
Judging from the pricing of export products, there is still a lot of room for price reduction.
Andon Health Co.Ltd(002432) 2021 disclosed on the investor interaction platform that the price of covid-19 antigen home self-test OTC kit sold on the official website of its U.S. subsidiary ihealth was $6.99/person (about 44.3 yuan / person). According to media reports, according to ihealth's official website in Hong Kong, Andon Health Co.Ltd(002432) covid-19 antigen rapid test kit (2 pieces / box) is priced at HK $140 (equivalent to about 113 yuan), and the price of a single copy is 56.5 yuan.
Whether in Hong Kong, China or in the United States, the price is higher than that of nucleic acid testing in China. It is understood that at present, the price of nucleic acid detection in Guangzhou is 33 yuan / person and that in Hangzhou is 40 yuan / person.
As more and more enterprises join the competition, the price of covid-19 antigen self-test products in the mainland may usher in a new round of price reduction.
how should the antigen self-test be implemented
On March 11, Zhang Wenhong, director of the infection department of Huashan Hospital Affiliated to Fudan University, said in an interview with the media that in the first stage of China's anti epidemic, the virus was "cleared" through the rapid battle of nucleic acid detection. However, after the Omicron mutant came out, the overall transmission speed of the virus was increasing. If the detection speed depended only on nucleic acid, it would be difficult. Antigen detection can be carried out at home, and the speed is very fast, which is conducive to improving the ability of "early detection".
The National Health Commission pointed out in the plan that antigen detection is used for screening of specific populations and can be applied to three groups of people: 1. People who go to grass-roots medical and health institutions with respiratory tract, fever and other symptoms and have symptoms within 5 days; 2. Isolation and observation personnel, including personnel in home isolation and observation, close connection and secondary close connection, entry isolation and observation, sealing and control area and control area; 3. Community residents with antigen self-test needs.
However, for open antigen home testing, some people in the industry have raised their concerns.
Wang Qiang, a medical device marketing training expert, told times finance and economics that antigen self-test can become an important means in the general screening and preliminary screening stage, which can reduce the burden of testing institutions. However, opening antigen home testing requires supporting measures to maintain the order of epidemic prevention. Otherwise, those who test positive may hide and do not report.
Jin Dongyan, a biomedical professor and virologist at the University of Hong Kong, told times finance that in Hong Kong, many work units require employees to conduct self-test and upload the test results before they can go out to work. The government will conduct random inspection and verification of the test results. If it is found to be concealed or forged, it will be investigated for legal responsibility.
Some industry insiders pointed out that the sensitivity of antigen detection is lower than that of nucleic acid detection, and open antigen self-test may lead to missed detection, wrong detection and so on.
Huang Ailong, member of the National Committee of the Chinese people's Political Consultative Conference and President of Chongqing Medical University, said in an interview that since 2021, some parts of the country have carried out large-scale emergency drills for rapid antigen detection of "home self-test", and the effect is no less than that of nucleic acid detection. "Taking Chongqing as an example, Chongqing Medical University has successively carried out drills with Bishan district and high tech Zone of Chongqing, distributed 16000 antigen rapid detection reagents, collected effective data for 15022 people, with an 8-hour completion rate of 75.11%; 15017 people identified as negative through the self-developed artificial intelligence system, and the consistency with the review of professional technicians is 99.97%." Huang Ailong said.
The above covid-19 antigen detection kit project document shows that the total coincidence rate of the five covid-19 antigen self-test products approved at present is more than 85%.
