"Science and Technology Innovation Board Daily" (Shanghai, reporter Xu Hong) news, a series of favorable policies stimulated, in just a few days, the concept of "new crown antigen detection" has been all over the market.
On March 11, the official website of the National Health commission officially released the "Notice on Printing and Distributing the Application Plan for New Coronavirus Antigen Detection (Trial)", indicating that in order to further optimize the new coronavirus detection strategy, according to the needs of epidemic prevention and control, the Comprehensive Group of the Joint Prevention and Control Mechanism of the State Council in response to the novel coronavirus pneumonia epidemic decided to add antigen detection as a supplement to nucleic acid testing, and organized the formulation of the "Application Plan for New Coronavirus Antigen Detection (Trial)" (hereinafter referred to as the "Plan").
The "Plan" clarifies for the first time the relevant policies for self-testing of antigens of the new crown virus, proposing: If community residents have self-testing needs, they can purchase antigen testing reagents for self-testing through retail pharmacies, online sales platforms and other channels.
Because this part of the content is interpreted by the market as the application of new crown antigen testing is not only limited to professional institutions (such as primary medical and health institutions) and specific groups (such as isolation observers), but also open to ordinary residents and retail channels, so the market imagination space of new crown antigen testing is completely opened.
However, at the time of the release of the above-mentioned "Plan", there were only 5 approved new crown antigen detection reagent products in China, and these 5 products also belonged to the "professional version" products, that is, "only professional and technical personnel, used in an environment to ensure biosecurity and meet the conditions of use", not the "self-test version" products suitable for ordinary community residents to "self-test at home".
But the next day (March 12), the State Food and Drug Administration issued a notice approving 688105. SH), Beijing Jinwolf, BGI (300676. SZ) subsidiary Shenzhen Huada Inyuan, Wanfu Bio (300482. SZ), Beijing Huaketai Biotech's self-test application for self-test application changes for new crown antigen products. It means that the first batch of 5 "self-testing versions" of new crown antigen detection reagents in China have been approved for listing.
On March 13, the State Food and Drug Administration approved the registration application of five new crown antigen self-testing products, which were from Wantai Bio (603392. SH), Heatscape Bio (688068. SH), Tianjin Boosaisi Biology, Chongqing Mingdao Jiezhi Biology and Lepu Medical (300003. SZ) subsidiary Lepu Diagnostics.
On March 14, the website of the State Food and Drug Administration showed that the Beijing Bell Biological New Crown Antibody Detection Kit was also approved.
So far, a total of 11 new crown antigen self-test products in China have been officially listed.
Due to the huge market space for the new crown antigen self-test, taking the european and American countries that use the new crown antigen home test as an epidemic prevention means as an example, according to relevant statistics, the new crown antigen home test covers about 70% of the population in Europe and the United States.
Therefore, after the State Food and Drug Administration announced that the first batch of "self-testing version" of the new crown antigen detection reagent was approved for listing, all parties quickly took action, hoping to get a share of this huge market.
Such as the listed chain pharmacy people (603883. SH), Large Ginseng Forest (603233. SH) announced at the first time that it will release new crown antigen rapid test products in their respective terminal channels.
At the same time, major e-commerce platforms have also launched new crown antigen self-test products. For example, Jingdong Health announced that it has reached cooperation with three domestic enterprises such as Heatscape Biology, Wantai Biology, and Lepu Diagnostics that have obtained the approval of the State Food and Drug Administration's "new crown antigen self-test" products, becoming its first online channel partner.
Production enterprises are also actively preparing for sales. Runuo Weizan said in an interview with the Financial Associated Press reporter that the company's new crown antigen self-test products have begun to be fully supplied after being approved, online channels can be purchased on e-commerce platforms such as Tmall Health and Suning Tesco, and the supply of offline pharmacies is also being prepared.
However, there are indications that despite the active preparations of the enterprise, the actual sales have not moved. On March 14, a reporter from the Financial Associated Press visited a number of offline pharmacy stores in many parts of the country (including ordinary people, large ginseng forests, etc.).
In this regard, according to the preliminary understanding of the reporter of the "Science and Technology Innovation Board Daily", one of the reasons for this situation may be because "the production capacity has not kept up". "As far as I know, the capacity allocation of production enterprises may need to cooperate with government arrangements, and priority will be given to supplying epidemic areas." Some insiders told reporters in this way.
On the afternoon of March 14, Jilin Province held a press conference on the prevention and control of the new crown epidemic. Song Xiaohui, deputy director of the Department of Industry and Information Technology of Jilin Province, said at the press conference that the Department of Industry and Information Technology of Jilin Province, through the National Health Commission and other channels, urgently communicated with antigen reagent manufacturers such as Beijing Heatscape Biology and Guangzhou Wanfu Biology, and ordered 12 million antigen detection reagents nationwide in a short period of time.
Song Xiaohui said that in accordance with the principles of ensuring the key points of guarantee, giving priority to emergency use, overall planning and taking into account, and scientific distribution, the Provincial Department of Industry and Information Technology has scientifically formulated a distribution plan and planned to distribute it to key areas such as Changchun, Jilin, and Yanbian.
"At present, not only offline, but also online is out of stock." The person familiar with the matter also said.
To this end, the reporter of the Science and Technology Innovation Board Daily specially inquired about the Jingdong mall and found that the new crown antigen detection kit in the flagship store of Heatscape Bio Jingdong can only be purchased by appointment at present, and its price is 124 yuan / 5 people, that is, 24.8 yuan / person. In addition, other platforms such as Tmall Health are only providing pre-sale services at present.
Just on March 14, the Tianjin Pharmaceutical Procurement Center issued the "Notice on Carrying out centralized maintenance of novel coronavirus antigen detection reagent information", indicating that it intends to carry out centralized maintenance of product information of new coronavirus antigen detection reagents from March 14.
Since the Tianjin Pharmaceutical Procurement Center has been responsible for the specific implementation of the joint procurement of high-value medical consumables organized by the state (that is, the "national collection of high-value consumables"), the "Notice" is considered to be a signal that the new crown antigen detection reagents are about to start a quantity procurement.
In this regard, the reporter of the Science and Technology Innovation Board Daily learned from the joint procurement office ("joint procurement office") of high-value medical consumables close to the national organization that the Tianjin Pharmaceutical Procurement Center only maintains product information.
"When the production capacity of the enterprise comes up, the market supply is sufficient, and when the supply exceeds the demand, then choose the opportunity to collect and collect." The authority source said. And this seems to confirm from the side that the current supply of domestic new crown antigen detection reagents may not have kept up for the time being.
"Now some companies still need to execute overseas orders." The other party told the "Science and Technology Innovation Board Daily" reporter.
On the other hand, the reporter of the Science and Technology Innovation Board Daily also learned from the local drug regulatory system that the current new crown antigen detection reagents have not yet been listed online and offline, or are also related to the relevant information of sales support, such as product manuals, and related sales processes and qualifications that need to be improved.
Earlier, Beijing Huaketai Company, one of the first batch of approved enterprises, also told the "Science and Technology Innovation Board Daily" reporter that the company is urgently formulating important materials such as training for new crown antigen testing products sent to customers.
At the same time, the company said that it is not clear when its new crown antigen testing products will 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 state's regulations on the use of data, testing environment, medical waste treatment and other aspects of new crown antigen self-test products are still unclear."
According to the Financial Associated Press reporter visited the Nanjing people's pharmacy, it was learned that customers need to bring their ID cards or medical insurance cards to the store to buy (new crown antigen testing reagents), and pharmacies need to register their real names and enter the drug supervision system.
In addition, the "Science and Technology Innovation Board Daily" reporter learned that the new crown antigen self-test agent belongs to the three types of medical devices, and pharmacies that originally have corresponding qualifications can only be sold. But this time, because of the special epidemic situation, the State Food and Drug Administration temporarily released it.
In the Notice on The Supervision of the Quality and Safety of New Coronavirus 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 drug business licenses or medical device business licenses and have corresponding storage conditions can sell new coronavirus antigen testing reagents.
"But even so, we still need to reissue the relevant operating qualifications to the operating enterprises first, which also takes time." The above-mentioned local drug regulatory system personnel told the "Science and Technology Innovation Board Daily" reporter.