With the liberalization of the policy, covid-19 antigen detection products are hot, and offline channel providers want to drink “first soup”.
On March 13, the State Food and Drug Administration approved the registration application of five covid-19 antigen detection kit products. These five enterprises include Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) , Beijing Hotgen Biotech Co.Ltd(688068) , Tianjin BIOSIS Biotechnology Co., Ltd., Chongqing Mingdao jietest Biotechnology Co., Ltd. and Beijing Lepu Diagnostic Technology Co., Ltd. So far, 10 covid-19 antigen detection kits have been approved in China.
Affected by the good news of policy liberalization, related covid-19 antigen detection concept stocks rose collectively on Monday. As of the closing on March 14, the shares of Guangzhou Wondfo Biotech Co.Ltd(300482) (SZ: Guangzhou Wondfo Biotech Co.Ltd(300482) ) rose 3.71%, the shares of Nanjing Vazyme Biotech Co.Ltd(688105) (SH: Nanjing Vazyme Biotech Co.Ltd(688105) ) rose 13.59%, and the shares of Bgi Genomics Co.Ltd(300676) (SZ: Bgi Genomics Co.Ltd(300676) ) rose 9.98%.
On March 13, a covid-19 antigen detection kit (latex method) produced by Beijing jinwofu was pre sold on the online platform.
March 14, Bgi Genomics Co.Ltd(300676) announced cooperation with 8 institutions (global procurement and supply chain service center of Sinopharm holdings, Medical Devices Co., Ltd. of China Resources pharmaceutical business group, Jointown Pharmaceutical Group Co.Ltd(600998) Medical Devices Group Co., Ltd., Dashenlin Pharmaceutical Group Co.Ltd(603233) , Yixintang Pharmaceutical Group Co.Ltd(002727) , Yunnan Jianzhijia Health-Chain Co.Ltd(605266) , Xi’an Yikang pharmaceutical chain Co., Ltd. and yiyaowang Technology Shanghai Co., Ltd.) Jointly signed the strategic cooperation framework agreement of covid-19 antigen detection kit, covering the cooperation intention of covid-19 antigen detection kit at the level of tens of millions of people.
On March 13, a number of retail drugstore enterprises publicly announced that they had reached a covid-19 antigen detection reagent product cooperation with Guangzhou Wondfo Biotech Co.Ltd(300482) and related products would be put on sale soon. However, it was publicly denied by the Guangzhou Wondfo Biotech Co.Ltd(300482) side, but the relevant content was deleted shortly after it was released.
With many covid-19 antigen detection reagent products approved for market application, on March 12, the State Food and drug administration also publicly issued the notice on the quality and safety supervision of covid-19 virus antigen detection reagent, emphasizing the strengthening of supervision and inspection of relevant business links.
antigen self test product price exposure
Since March 13, a covid-19 antigen detection kit (latex method) produced by Beijing jinwofu, which is provided by jinshanda pharmacy and linzhengtang medical equipment, has been put on the meituan drug purchase platform for pre-sale at a price of 32.8 yuan. It is expected to be delivered around the 20th.
Many people in the industry admitted to the 21st Century Business Herald reporter that 30 yuan is the initial price. We all think it is expensive, and there will certainly be room for decline. Of course, it also depends on how to introduce the use scenarios and various supporting specifications and regulations in the future.
Previously, a person in charge of pharmaceutical e-commerce platform introduced in an interview with the media that Guangzhou Wondfo Biotech Co.Ltd(300482) products are priced at 16.8 yuan / piece in the hospital, and the price of retail platform should fluctuate here. For the specific price, the above person in charge said that the price is independent pricing and market behavior in principle. However, if the national medical insurance fund is used and can be reported in proportion, the price will be subject to bidding, and the medical insurance will be controlled. Finally, the price will be subject to the price control of the manufacturer and the government after the actual arrival.
In fact, it is worth mentioning that in April 2021 -5, the Guangdong drug Exchange Center launched New Coronavirus (2019-nCoV) testing reagent alliance regional group purchasing with quantity. According to the “New Coronavirus (2019-nCoV) test reagent alliance regional group purchasing document” issued at that time, the COVID-19 test reagent with quantity purchase was divided into 5 kinds, and the antigen detection reagent was fourth kinds. In terms of specific price, the quotation of antigen detection reagent is required to be ≤ 30 yuan / person.
At that time, only Guangzhou Wondfo Biotech Co.Ltd(300482) carried out the volume purchase report, and the purchase demand was 203504 people. Finally, it was selected with 16.80 yuan / person.
(Figure: Guangdong Pharmaceutical Trading Center)
According to the application scheme for covid-19 virus antigen detection (Trial) launched by the National Health Commission on March 11, when grass-roots medical and health institutions receive people with respiratory tract, fever and other symptoms within 5 days, they will carry out antigenic detection without nucleic acid detection ability, and the antigen detection reagents equipped by grass-roots medical and health institutions will be included in centralized bidding and procurement, Through provincial centralized bidding and procurement, the price of testing reagents can be continuously reduced to reduce the burden of testing costs.
compared with nucleic acid detection, its price has also decreased from the beginning Taking Guangdong Province as an example, from 2020 to the end of 2021, the total cost of testing in Guangdong Province (testing service fee 25 yuan + testing reagent price) decreased from the initial average price of more than 100 yuan per person to an average price of 33.2 yuan; The price of mixed testing of 5 samples and 10 samples was reduced from 20 yuan per person to 8 yuan. Behind the price reduction, Guangdong took the lead in organizing the alliance of six provinces to carry out the centralized purchase of nucleic acid detection kits and the pricing of “technology consumption separation” of detection services.
Yu Feng, general manager of Guangdong Pharmaceutical Trading Center, said in an interview with the media, “The price of volume purchase will not be lower or lower. The price is formed in the market. There is a threshold for reduction. If it exceeds the bearing range of the enterprise, such centralized purchase will not succeed. Centralized purchase is more to achieve win-win results, which not only meets the drug needs of medical institutions and patients, but also enables the production enterprises to have stable production and marketing expectations, and the industry will develop in an orderly manner.”
different products have different use methods and accuracy
As of March 13, the State Food and drug administration has approved 10 covid-19 antigen self-test products, including Guangzhou Wondfo Biotech Co.Ltd(300482) , Huada Yinyuan, Beijing jinwofu, Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) , huaketai biology, Beijing Wantai, Beijing rexing, Tianjin boosses, Chongqing Mingdao jietest and Beijing Lepu.
At present, China has approved three kinds of antigen tests, including Guangzhou Wondfo Biotech Co.Ltd(300482) , Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) , Beijing Wan Tai, Beijing hot spot, Tianjin Bo OSSE, Chongqing Ming Dao Jie test and Beijing Le Pu 7 companies. The New Coronavirus antigen detection kit is colloidal gold method, Huada Yin yuan and Beijing huakutai biological production are fluorescent immunoassay methods. Beijing jinwofu produces latex method.
In general, fluorescence method requires detection instruments, which are generally used for large-scale isolation points or centralized detection in public places; Colloidal gold, similar to pregnancy test stick, does not need testing instruments and is more suitable for home testing.
In terms of detection accuracy, the accuracy of using instruments is relatively higher.
(Figure: operation diagram of covid-19 virus antigen detection kit produced by Beijing jinwofu)
According to Bgi Genomics Co.Ltd(300676) ‘s public information, Bgi Genomics Co.Ltd(300676) Bgi Genomics Co.Ltd(300676) (2019-nCoV) antigen detection kit (fluorescence immunochromatography) needs to be used in conjunction with dry fluorescent immunoassay analyzer. The detection result is stable and specific. It can realize rapid detection, and has the advantages of automatic interpretation test results and information management test samples.
21st Century Business Herald reporter consulted Huada covid-19 antigen detection customer service line, which only said that the kit and analyzer are sold together, but the price is not clear. If you want to buy, you can only leave your contact information and wait for the next noticecenter style=”text-align:center;”> center>
(Figure: Bgi Genomics Co.Ltd(300676) official account)
production cost is adjustable and the enterprise has sufficient capacity
The research report released by Gf Securities Co.Ltd(000776) Development Research Center shows that at present, the production cost of single copy of antigen self-test reagent in China is about 2-3 yuan, which is mainly composed of biological raw materials, NC film, plastic parts and labor. Among them, the expenditure on labor and plastic parts is generally stable, and the price fluctuation of biological raw materials and NC film will have a great impact on the cost.
The main manufacturers of antigen self-test reagents have a high proportion of self-produced raw materials and strong ability to adjust the cost. Therefore, Gf Securities Co.Ltd(000776) believes that in the extreme case, production cost can be reduced to 1.5 yuan (the contract manufacturer’s order receiving price is 1.9-2.5 yuan per piece) and up to 4 yuan (exported to high demand markets such as the United States) . At present, the average price of Chinese enterprises exporting to Europe is about US $0.9 per person (5.5 yuan per person), and exporting to the United States is about US $2 per person (12 yuan per person). It is supplied to Hong Kong, China and currently approved enterprises. The quotation to the mainland channel is 12 yuan / person.
according to Gf Securities Co.Ltd(000776) prediction, assuming that enterprises generally report data to the supervision department according to the highest cost and refer to the price of nucleic acid reagent, the Chinese government’s guidance price / purchase price in the early stage may be about 8 yuan / person, and may be as low as 5 yuan / person after the supply is improved in the later stage
A person from the in vitro testing industry in South China told the 21st Century Business Herald reporter that the cost of antigen kit is certainly lower than that of nucleic acid kit, and for different variants of viruses, generally, if the conventional reagent is developed, the cost is still high and the cycle will be longer, because it needs to be clinical. However, the covid-19 variant is in an urgent situation. Many products are subject to emergency approval. After the initial performance of development is completed, they are put into operation first, and then the clinical effect is tested. Therefore, the actual listing cycle of each product is also relatively short.
In addition, according to his introduction, in the whole industry, China’s relevant prices, whether nucleic acid or future antigens, must be the first to meet the demand for anti epidemic, and the highest profit of antigen detection in the past also came from exports, not the Chinese market.
According to Ping An Securities Research Report, the technical barriers of antigen detection products are not high, and the entry barriers in the short term are mainly composed of registration certificate and supply capacity. The supply capacity includes the capacity of end products and the supply chain control ability of raw materials.
According to Gf Securities Co.Ltd(000776) understanding, the current product capacity of China’s antigen self-test industry is about 3-4 billion people / month, and the actual output is about 2 billion people / month. It is generally believed that there is a capacity gap in the early stage, but the product launch rate will not be slow in the later stage. In addition, the current nucleic acid detection capacity is also relatively sufficient.
Once the antigen detection reagent is implemented on a large scale, it will give birth to a huge demand for dosage and become a consumer grade medical product, with a considerable market scale.
However, some people in the industry take a cautious wait-and-see attitude and believe that from the current situation, the demand for rapid and large-scale screening in public places where people gather is more urgent. Considering the impact of factors such as cost, acceptance, storage and use threshold, the promotion and popularization of home self-test may take a long time.
It is worth noting that when manufacturers accelerate the supply of drugs to pharmacies and online drug sales platforms, the national regulatory authorities also issued an announcement to strengthen the supervision and inspection of covid-19 virus antigen detection reagent operators.
On March 12, the comprehensive Department of the State Food and Drug Administration issued the notice on the quality and safety supervision of covid-19 virus antigen detection reagents, emphasizing the strengthening of supervision and inspection of relevant business links.
It is pointed out that the provincial drug supervision and administration departments should continue to strengthen the monitoring and disposal of covid-19 virus detection reagent network transaction information, and timely organize the investigation and punishment of illegal clues found in the monitoring. Strengthen the supervision and inspection of the third-party platform for online trading services of medical devices under its jurisdiction, supervise and guide them to strictly perform their obligations of real name registration, qualification review and business behavior management of online medical device operators, and timely stop and report to the drug regulatory department in case of illegal sales of medical devices.
The comprehensive Department of the State Food and drug administration requires to focus on whether the covid-19 virus antigen detection reagent operated by the enterprise has been registered and approved and has qualification certificates, and whether the product manual contains the instructions for individual use by consumers. For the medical device business enterprises engaged in online sales, they should also be urged to display the medical device business license in a prominent position on the main page of the website and the medical device registration certificate and other information on the product page.
