21st Century Business Herald reporter Zhu Yiyi reported from Hangzhou
"Can the company's monthly production capacity of 200 million doses in 2022 be fulfilled?" "How much is the company's test reagent sold to the UK and the US per person?" On the interactive platform of the Shanghai and Shenzhen Exchanges, the foreign "hard-to-find" new crown virus test kit has also driven the concept of A-share "new crown" testing.
On January 12, Jiuan Medical (002432. SZ) followed the 11th limit and then closed the limit, Oriental Bio (688298. SH) rose 18 percent, with Yahuilong (688575. SH) rose 11%, based on egg organisms (603387. SH) also closed a limit.
On the evening of January 12, Jiuan Medical disclosed the progress of major contracts and orders: iHealth, the U.S. subsidiary that produces the COVID-19 self-test OTC kit, and the New York State Department of Health have ordered and contracted for a cumulative amount of US$185 million (about 1.180 billion yuan), and the cumulative amount of orders with the Executive Office of the Federal and Health and Human Services Department of Massachusetts is 148 million US dollars (about 944 million yuan). The two orders and contracts totaled RMB2.124 billion, equivalent to 2.6 times the revenue of Jiuan Medical in the first three quarters of 2021 (RMB790 million).
And the recent hot Anxu Biological (688075. SH) has also harvested "20cm" four consecutive boards, Heatscape Bio (688068.SH) has risen more than 60% in 5 trading days since January 5, Aotai Bio (688606. SH) has surged nearly 60% in three trading days since Jan. 10.
With the spread of the "new crown" variant virus Omicron, the global epidemic situation is still severe, and the new crown antigen self-testing agent cartridge produced by Jiuan Medical, Oriental Biologics and other companies has taken the lead in obtaining a pass to enter the US market - euca ("emergency use authorization") from the FDA ("U.S. Food and Drug Administration").
At the same time, Meikang Bio (300439.SZ), Botuo Bio (688767.SH), Wantai Bio (603392.SH), Wanfu Bio (300482.SZ) and other companies have said that their new crown detection reagent products are also preparing to apply for FDA certification in the United States.
Jiuan Medical and Oriental Bio "rushed to run" and have been authorized by the FDA for emergency use
According to public information, among the 12 household self-test kit manufacturers that have obtained the emergency use authorization of the US FDA EUA, there are only 3 domestic enterprises, namely Hangzhou Aikang Biological (unlisted), Jiuan Medical and Dongfang Bio (Siemens Medical Authorized Supplier).
Among them, Jiuan Medical, which has been established for 27 years and mainly sells electronic medical devices such as body temperature, blood pressure, blood glucose, and blood oxygen, has suddenly become a "capital darling" in the two months near the end of 2021.
On November 7, 2021, Jiuan Medical issued an announcement, "Learned in the early morning of Saturday, November 6, 2021, Beijing time, authorized by the U.S. Food and Drug Administration (FDA), the Company's U.S. subsidiary, iHealth Labs Inc. The NOVEL CORONAVIRUS (SARS-CoV-2) antigen self-test OTC kit (Colloidal Gold Immunochromatography) ("iHealth USA") is authorized for emergency use (EUA) and can be sold in the United States and countries that recognize the U.S. EUA during the U.S. public health emergency."
This paper announcement opened the prelude to its soaring.
Starting from The first disclosure of the new crown self-test OTC kit by Jiuan Medical on November 7, 2021 to the AUTHORIZATION of the US FDA EUA, as of January 12, Jiuan Medical has obtained 25 up and down boards, with a cumulative increase of 937%.
Since then, Jiuan Medical has repeatedly answered questions about the "new crown" test kit on the interactive platform, adding a fire to its soaring market.
Jiuan Medical mainly sells new crown antigen home self-test OTC kits through the 70.46% U.S. subsidiary iHealth independent brand, and the sales channels are independent website + Amazon, government orders, and commercial customers.
According to the disclosure, Jiuan Medical's in-hand orders are "As of December 27, 2021, US time, it has received a total of 47.43 million government orders from Massachusetts, California, New York, Washington, Washington, Louisiana, Maryland and Oregon, and has shipped 8.82 million copies, has received $62.55 million (including advance payments), and has received orders of $174.6 million." Sales collections for commercial customers amounted to $36.19 million, and sales to the company's website and Amazon USA amounted to $68.35 million.
In addition to the orders in hand that attract the attention of the market, the production capacity of Jiuan Medical has made the market more reverie.
In response to the production capacity of the kit, Jiuan Medical said in an interview with Huaan Fund, Huatai Berry, Wanjia Fund and other institutions on December 29, "The company's current monthly production capacity is 100 million copies, and it is estimated that by the beginning of 2022, the production capacity will increase to 200 million copies per month, and the actual capacity expansion and production plan will be adjusted in real time according to the actual situation of the market, orders, and raw material supply." ”
The further spread of the Aomi Kerong mutant virus at home and abroad has added fuel to the already hot Jiu'an medical market.
Jiuan Medical said on January 7 that on the evening of January 5, 2022, Beijing time, it received a test performance report from the NATIONAL INSTITUTES OF HEALTH's RADx project arranged by the US FDA on the test performance of the iHealth new crown antigen home self-test OTC kit against the Omicron variant virus. The report shows that iHealth's kit detected 100% of the Omicron active virus samples with a maximum CT value of 21.59 (n=5) in the experiment.
On January 10, Jiuan Medical further disclosed through the Investor Relations Activity Record Form that it had submitted the "Proposal on Using Family Self-Test Boxes to Achieve 1+1 COVID-1 Prevention of the New Crown epidemic in Aomi Kerong" to the Tianjin Municipal Epidemic Prevention and Control Command. The relevant departments of Tianjin Municipality are studying the company's plan. ”
On the evening of January 12, Jiuan Medical disclosed the progress of major contracts and orders: iHealth, the US subsidiary that produced the NEW CROWN self-test OTC kit, and the New York State Department of Health had a cumulative order and contract amount of US$185 million (about 1.180 billion yuan), and the cumulative amount of orders with the Executive Office of the Federal and Health and Human Services Department of Massachusetts was 148 million US dollars (about 944 million yuan). The two orders and contracts totaled RMB2.124 billion, equivalent to 2.6 times the revenue of Jiuan Medical in the first three quarters of 2021 (RMB790 million).
However, despite the strong domestic and foreign demand for kits and the fact that Jiuan Medical has also received relevant orders, it remains to be verified to what extent Jiuan Medical can boost its performance with the help of this "going to sea" business.
The 21st Century Business Herald reporter found that the eye-catching Jiuan Medical U.S. subsidiary iHealth is still in a state of loss in 2020, with a net profit of -78.9257 million yuan.
Jiuan Medical's own performance is not optimistic, after continuous losses from 2016 to 2019, until 2020 deduction of non-net profit turned positive to 248 million yuan.
In the first three quarters of 2021, Jiuan Medical achieved revenue of 790 million yuan, down 50.82% year-on-year; deducting non-net profit was -24.775 million yuan, down 106.89% year-on-year.
After the high-profile release of information, Jiuan Medical has received four letters of concern from the Shenzhen Stock Exchange, asking whether the company has selectively disclosed some information to hype the stock price.
In contrast, Oriental Biologics, a domestic capital market "newcomer" that just landed on the Science and Technology Innovation Board in February 2020, is much more low-key.
On December 30, 2021, Dongfang Biotech announced that Siemens Healthcare's "CLINITEST" novel coronavirus antigen self-testing agent, a customer of its wholly-owned subsidiary, Hengjian Biotechnology Co., Ltd., was authorized for emergency use by the FDA EUA on December 30, 2021 Beijing time, and can be sold in the United States and countries that recognize the USUA during the US public health emergency. Its subsidiary, AG, is the designated authorized supplier of the self-testing agent.
However, for the impact of the approval of the test agent, Dongfang Bio only said, "The future sales performance of the product in the United States mainly depends on the sales capacity and order situation of Siemens Healthcare in the United States... It is currently impossible to predict the impact on the Company's future operating results."
Dongfang Bio mainly specializes in in vitro diagnostic products, and its business areas cover POCT rapid diagnosis platform, molecular diagnosis platform and liquid biochip platform. At present, the revenue and profit mainly come from POCT rapid diagnostic reagents, which are mainly used in infectious disease detection (including new coronavirus detection series products), drug detection, tumor marker detection, myocardial marker detection, eugenics and eugenics testing and other business fields, hundreds of products, products have been exported to more than 100 countries and regions around the world.
On January 12, the 21st Century Business Herald reporter repeatedly called the Oriental Biological Securities Affairs Department to further understand the situation of the new crown test agent, but the phone was not answered.
Harvest four "20cm" stop-and-go Anxu biology, there is a layout
Since its establishment in 2008, Anxu Biologics, which has harvested four "20cm" limits, has been focusing on the research and development, production and sales of in vitro diagnostic products, and is obviously more prepared in the layout of new crown detection reagents, and has obtained certification in many places.
In fact, as early as the prospectus (registration draft) at the end of 2020, Anxu Bio mentioned that the new coronavirus detection reagent (immunochromatography method) developed by the company was sold to overseas markets from March 2020, and the cumulative sales revenue by the end of 2020 has reached 986 million yuan, driving the company's revenue in 2020 to 1.199 billion yuan and net profit of 649 million yuan, respectively, an increase of 471.86% and 1091.96% respectively. From January to June 2021, the cumulative sales revenue was 363 million yuan, driving the company's revenue in the first half of 2021 to 494 million yuan and net profit to 202 million yuan, an increase of 60.59% and 17.68% respectively.
As of the date of signing of the prospectus, Anxu Bio said, "The new crown antibody detection reagent products have completed the EU CE certification, the Canadian MDL certification and the US FDA EUA Class C application, and the new crown virus antigen detection reagent products have completed the Canadian MDL certification and the EU CE certification."
On December 27, 2021, Anxu Further Disclosed that the company's new coronavirus antigen nasal test reagent (self-test) recently obtained the EU CE certification.
This means that the company's COVID-19 antigen self-testing agent products (extended to May 26, 2024) and the NEW CORONA ANTIGEN nasal testing reagent (self-test) have both obtained EU CE certification, but the certification time is relatively late.
At the same time, in response to the mutant virus Omicron (Omicron), the official public account of Anxu Bio released an "Updated Explanation on the Detection of the Novel Coronavirus Mutation Strain Omicron" on December 3, mentioning, "The laboratory evaluation that has just been completed shows that the detection sensitivity of the recombinant antigen of the assay kit produced by our company for the mutant virus Omicron (Omilon) has not been different. That is, the detection effect of the kit on the mutant virus Omicron (Omikeron) has not been affected, and the verification of clinical specimens and strains of the mutant virus Omicron is ongoing."
Recently, Anxu Bio was also reported by the media that due to the great increase in demand for new crown testing reagent products, "students were recruited from vocational schools, and some temporary workers were also recruited to rush to work."
In this regard, on the evening of January 11, Anxu Bio issued a change announcement, saying, "After the company's self-examination, the relevant reports recently mentioned that it had visited the company on the spot. The recruitment of temporary workers and interns is a normal demand for the company's operations and has not changed significantly. Coupled with the approaching Spring Festival, most of the workers returned home early."
At the same time, Anxu Bio announced the 2021 annual performance forecast, and it is expected that the net profit attributable to the mother in 2021 will be 658 million yuan to 790 million yuan, an increase of 1.41% to 21.69% year-on-year.
A shares new crown test "sea go-to-sea" to follow
Although 12 companies have obtained the emergency use authorization of the US FDA EUA, the market competition is fierce, but it is impossible to resist more A-share listed companies to join the team.
"Our company's new crown testing products are mainly sold in Europe, Southeast Asia and other places, and have obtained the EU CE certification, and the company's new crown testing products are ready to apply for certification to the US FDA." On January 12, the 21st Century Business Herald reporter learned from meikang biological related people.
In addition, the above-mentioned person of Meikang Bio said, "At present, the company's domestic new crown testing product registration certificate is still registered, and the company's new crown products are currently only sold overseas."
Coincidentally, In early December 2021, Botuo Bio replied to investors' questions, mentioning, "In June 2020, the company's new crown antibody testing reagent products obtained the EUA authorization of the US FDA, and in September 2020, the new crown antigen home self-testing reagent obtained the EU CE certification, and the company actively expanded overseas markets after obtaining the certificate... The company's application for FDA certification of new crown antigen self-testing products is in progress, and the information disclosure obligation will be fulfilled in a timely manner after obtaining the certificate."
Another A-share listed company, Wanfu Bio, said on the interactive platform in November 2021, "The company has accumulated a good business foundation in 17 years of overseas market expansion, and the company's new crown detection reagents have been sold in Europe, Asia, the Middle East, Latin America and other countries and regions." In the first three quarters of 2021, the company's NEW CROWN business achieved revenue of about 800 million yuan, most of which came from the sales contribution of new crown antigen self-test products in overseas markets. ”
According to the incomplete statistics of the 21st Century Business Herald reporter, in addition to Wanfu Biology, the new crown self-test kit of ten enterprises such as Botuo Biological, Heatscape Biological, Ji Egg Biological, Daan Gene, Yahuilong, Andean Diagnostics has also been approved abroad.
Many A-share companies have deployed overseas, and there is no shortage of new crown testing business to boost the company's performance.
Just a few days ago, Heatscape Bio released its 2021 performance forecast, and it is expected to achieve a net profit attributable to the mother of 2 billion yuan to 2.35 billion yuan in 2021, up as much as 1684.65% to 1996.97% year-on-year.
Heatscape Bio said, "In the first half of 2021, the company's new coronavirus antigen detection kit obtained the certification of the German Federal Institute of Drugs and Medical Devices (BfArM) for home free testing, which can be sold in german supermarkets, pharmacies, Internet stores, etc., and foreign trade orders have exploded; in the second half of the year, the new coronavirus antigen determination kit has successively obtained the self-test registration/filing of major economies such as the EUROPEAN Union CE, the British MHRA, and the French ANSM. In particular, in the fourth quarter, affected by the Delta and Omicron strains of the new crown virus, the new crown pneumonia epidemic in Europe, Southeast Asia and other countries and regions remained high, resulting in a significant increase in the demand for new crown antigen test reagents, and the income of overseas new crown test reagents increased sharply."
In addition, as of now, the new crown (2019-nCoV) antigen detection kit (colloidal gold method) (self-test version) has obtained the MDA certification of the Malaysian Ministry of Health, the CE certification of the European Union, and completed the registration/filing of the United Kingdom MHRA, Estonia SM, Finland STM, Austria BASG, Bosnia and Herzegovina FMZ and other countries, and it is expected to achieve a net profit of 1.3 billion yuan - 1.5 billion yuan in 2021, an increase of 177.23% - 219.88% year-on-year.
Another related company, Kaipu Bio (300639. SZ) expects to achieve a net profit of 800 million yuan - 860 million yuan for the whole year of 2021, an increase of 120.59% - 137.14% year-on-year.
For the continuation of the overseas epidemic, Ping An Securities said that it will drive the demand for reagents to rise, and the sales volume of new crown testing reagents is expected to increase, or it will bring performance flexibility to related enterprises.
However, some relevant company people pointed out to the 21st Century Business Herald reporter that "although many companies are applying for EUA authorization from the FDA, the process will take several months, including clinical test applications, reagent clinical tests, providing clinical test reports, etc., so it still takes time for subsequent companies to be approved." ”
In a few months, the development of the virus and the market situation of the new crown detection reagent will change, or it may have an impact on the effectiveness of these companies' products.
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