Stimulated by a series of favorable policies, the concept of “covid-19 antigen detection” was popular all over the market in just a few days.
In March 11th, the national Wei Jian administration official website issued the notice on the issuance of the COVID-19 virus antigen detection application plan (Trial Implementation). It indicated that in order to further optimize the COVID-19 virus detection strategy, according to the epidemic prevention and control needs, the State Council should decide to add the antigen test to the New Coronavirus disease prevention and control mechanism integrated group based on nucleic acid detection as a supplement. It also organized and formulated the application scheme for covid-19 virus antigen detection (Trial) (hereinafter referred to as the “scheme”).
The plan defines the relevant policies for covid-19 virus antigen self-test for the first time, and puts forward that if community residents have self-test needs, they can purchase antigen test reagents for self-test through retail pharmacies, online sales platforms and other channels.
because this part is interpreted by the market as that the application of covid-19 antigen detection is not only limited to professional institutions (such as grass-roots medical and health institutions) and specific groups (such as isolated observers), but also open to ordinary residents and retail channels, so the market imagination space of covid-19 antigen detection will be completely opened
However, at the time of the release of the above plan, there were only five approved covid-19 antigen detection reagent products in China, and these five products were also “professional” products, that is, “only professional technicians can use them in an environment that ensures biosafety and meets the use conditions”, which was not a “self-test version” product suitable for “home self-test” of ordinary community residents.
However, on the second day (March 12), the State Food and Drug Administration issued a notice approving the application change of covid-19 anti origin product self-test application of Nanjing Vazyme Biotech Co.Ltd(688105) ( Nanjing Vazyme Biotech Co.Ltd(688105) . SH), Beijing jinwofu, Bgi Genomics Co.Ltd(300676) ( Bgi Genomics Co.Ltd(300676) . SZ) subsidiary Shenzhen Huada Yinyuan, Guangzhou Wondfo Biotech Co.Ltd(300482) ( Guangzhou Wondfo Biotech Co.Ltd(300482) . SZ) and Beijing huaketai biology means that China’s first five “self-test version” covid-19 antigen detection reagents have been approved for marketing
On March 13, the State Food and drug administration again approved the registration applications of five covid-19 antigen self-test products, which came from the subsidiaries of Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) ( Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) . SH), Beijing Hotgen Biotech Co.Ltd(688068) ( Beijing Hotgen Biotech Co.Ltd(688068) . SH), Tianjin boosses biology, Chongqing Mingdao jietest biology and Lepu Medical Technology (Beijing) Co.Ltd(300003) ( Lepu Medical Technology (Beijing) Co.Ltd(300003) . SZ).
so far, 10 covid-19 antigen self-test products have been officially launched in China
Due to the huge market space of covid-19 antigen self-test, take European and American countries that use covid-19 antigen home self-test as epidemic prevention means as an example. According to relevant statistics, covid-19 antigen home self-test covers about 70% of the population in Europe and America.
All parties hope to get a share of the first batch of self-test reagents from the National Drug Administration after the launch of the “vid-19” vaccine.
For example, listed chain drugstores Lbx Pharmacy Chain Joint Stock Company(603883) ( Lbx Pharmacy Chain Joint Stock Company(603883) . SH) and Dashenlin Pharmaceutical Group Co.Ltd(603233) ( Dashenlin Pharmaceutical Group Co.Ltd(603233) . SH) announced at the first time that they would sell covid-19 antigen rapid test products in their respective terminal channels.
At the same time, major e-commerce platforms have also launched covid-19 antigen self-test products. For example, JD Health announced that it had entered into cooperation with three Chinese enterprises, including Beijing Hotgen Biotech Co.Ltd(688068) , Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) , and Lepu diagnosis, which were approved by the “covid-19 antigen self-test” product of the State Food and drug administration, and became its first online channel partner.
Production enterprises are also actively preparing for sales. For example, Nanjing Vazyme Biotech Co.Ltd(688105) said in an interview with the financial associated press that the company’s covid-19 antigen self-test products have begun to be fully supplied after being approved. Online channels can be purchased on tmall health, Suning.Com Co.Ltd(002024) and other e-commerce platforms, and the supply of offline pharmacies is also being prepared.
however, there are various signs that despite the positive preparations of the enterprise, the actual sales have never been dynamic march 14, the reporter of the financial Associated Press visited many offline drugstores in many places across the country (including Lbx Pharmacy Chain Joint Stock Company(603883) , Dashenlin Pharmaceutical Group Co.Ltd(603233) , etc.),
They were told that there was no goods on the shelves.
In this regard, according to the preliminary understanding of the reporter of science and Innovation Board daily, one of the reasons for this situation is that “the production capacity has not kept up” . “As far as I know, the production capacity allocation of production enterprises may need to cooperate with the government’s arrangement and will give priority to the supply of epidemic areas.” Insiders told reporters.
On the afternoon of March 14, Jilin Province held a press conference on covid-19 epidemic prevention and control. Song Xiaohui, deputy director of Jilin Provincial Department of industry and information technology, said at the press conference that Jilin Provincial Department of industry and information technology urgently communicated with antigen reagent manufacturers such as Beijing Beijing Hotgen Biotech Co.Ltd(688068) and Guangzhou Guangzhou Wondfo Biotech Co.Ltd(300482) through the National Health Commission and other channels, and ordered 12 million antigenic testing reagents nationwide in a short time.
Song Xiaohui said that in accordance with the principles of ensuring key protection, giving priority to urgent needs, overall consideration and scientific distribution, the Provincial Department of industry and information technology scientifically formulated the distribution plan and planned to distribute it to key areas such as Changchun, Jilin and Yanbian.
“At present, it is not only offline, but also online.” The aforementioned insider said.
To this end, the reporter of “science and Innovation Board daily” specially inquired Jingdong Mall and found that the covid-19 antigen detection kit of Beijing Hotgen Biotech Co.Ltd(688068) Jingdong self operated flagship store can only be purchased by appointment at present, and its price is 124 yuan / 5 people, or 24.8 yuan / person. In addition, tmall health and other platforms only provide pre-sale services.
In March 14th, the Tianjin pharmaceutical procurement center issued the circular on the centralized maintenance of New Coronavirus antigen detection reagent information, indicating that it is planned to carry out the centralized maintenance of New Coronavirus antigen detection reagent products in March 14th.
Previously, Tianjin pharmaceutical procurement center has been responsible for the specific implementation of the joint procurement of high-value medical consumables organized by the state (i.e. “national centralized procurement of high-value consumables”), therefore, the notice is considered to be a signal that covid-19 antigen detection reagent will be purchased in batches.
In this regard, the reporter of science and Innovation Board daily learned from a person close to the joint procurement office of high-value medical consumables organized by the state (“joint procurement”), that at present, Tianjin pharmaceutical procurement center only maintains product information.
“when the enterprise’s production capacity comes up, the market supply is sufficient, and the supply exceeds the demand, we will choose the opportunity to carry out centralized purchase.” The authority said. This also seems to confirm from the side that the current supply of covid-19 antigen detection reagents in China may not keep up for the time being
“Now some enterprises still need to execute overseas orders.” The other party told the reporter of science and Innovation Board daily.
On the other hand, the reporter of the science and Innovation Board daily also learned from the local drug regulatory system that covid-19 antigen detection reagent has not been put on the shelves online or offline, or the relevant materials supporting the sales, such as product manuals, as well as the relevant sales processes and qualifications, need to be improved
Earlier, Beijing huaketai company, one of the first batch of approved enterprises, also told the reporter of Kechuang board daily that the company is urgently formulating important materials such as the training of covid-19 antigen detection products sent to customers.
The company also said that it was unclear when its covid-19 antigen detection products would be listed in pharmacies. “On the one hand, the company’s previous market channels were mainly concentrated in hospitals and other medical institutions, on the other hand, the national regulations on the data use, detection environment and medical waste treatment of covid-19 antigen self-test products are still unclear”.
In addition, according to the financial Associated Press reporter’s visit to Nanjing Lbx Pharmacy Chain Joint Stock Company(603883) pharmacy, customers need to bring their ID card or medical insurance card to the store to buy (covid-19 antigen detection reagent), and the pharmacy needs to register their real name and enter it into the drug supervision system.
In addition, the reporter of the science and Innovation Board daily learned that covid-19 antigen self-test reagent belongs to three types of medical devices, which can only be sold by pharmacies with corresponding qualifications. But this time, because of the special epidemic situation, the State Food and drug administration temporarily released it
In the notice on the quality and safety supervision of covid-19 virus antigen detection reagents issued on March 12, the State Food and Drug Administration said that during the epidemic prevention and control period, retail pharmacies and medical device trading enterprises that have obtained the drug trading license or medical device trading license and have the corresponding storage conditions, Covid-19 virus antigen detection reagent can be sold
“But even so, we still need to reissue relevant business qualifications to the operating enterprises first, which also takes time.” The aforementioned people from the local drug administration system told the reporter of the science and Innovation Board daily
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