"Can the company's annual capacity of 200 million doses in 2022 be fulfilled?" "How much is the company's testing reagent sold to Britain and the United States for each person?" On the interactive platform of Shanghai and Shenzhen Stock Exchange, the foreign "hard to find" covid-19 virus detection kit has also driven the A-share "covid-19" detection concept.
On January 12, Andon Health Co.Ltd(002432) (002432. SZ) closed the daily limit after the daily limit on January 11, Zhejiang Orient Gene Biotech Co.Ltd(688298) (688298. SH) rose 18%, Shenzhen Yhlo Biotech Co.Ltd(688575) (688575. SH) rose 11%, and Getein Biotech Inc(603387) (603387. SH) also closed the next daily limit.
On January 12, Andon Health Co.Ltd(002432) disclosed the progress of major contracts and orders: the cumulative amount of orders and contracts between ihealth, a U.S. subsidiary producing covid-19 self-test OTC kit, and the Department of health of New York state was 185 million US dollars (about 1.180 billion yuan), The cumulative amount of orders with the Executive Office of the Federal Department of health and human services in Massachusetts was US $148 million (about RMB 944 million). two orders and contracts totaled RMB 2.124 billion, equivalent to 2.6 times of the revenue of Andon Health Co.Ltd(002432) in the first three quarters of 2021 (RMB 790 million).
The recently hot Asahi Biology (688075. SH) has harvested a "20cm" four link board, Beijing Hotgen Biotech Co.Ltd(688068) (688068. SH) has increased by more than 60% in the five trading days since January 5, and Hangzhou Alltest Biotech Co.Ltd(688606) (688606. SH) has increased by nearly 60% in the three trading days since January 10.
with the spread of "covid-19" mutant virus Omicron, the global epidemic is still severe. Covid-19 antigen self-test kit produced by Andon Health Co.Ltd(002432) , Zhejiang Orient Gene Biotech Co.Ltd(688298) and other companies took the lead in obtaining a pass to enter the U.S. market - the EUA ("emergency use authorization") of FDA ("U.S. food and Drug Administration").
At the same time, Medicalsystem Biotechnology Co.Ltd(300439) (300439. SZ), Hangzhou Biotest Biotech Co.Ltd(688767) (688767. SH), Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) (603392. SH), Guangzhou Wondfo Biotech Co.Ltd(300482) (300482. SZ) and other companies have said that their covid-19 detection reagent products are also preparing to apply for FDA certification in the United States.
Andon Health Co.Ltd(002432) , Zhejiang Orient Gene Biotech Co.Ltd(688298) "rush", which has been authorized by FDA for emergency use
according to public information, among the 12 domestic self-test kit manufacturers authorized by the FDA EUA for emergency use, only three Chinese enterprises are Hangzhou Aikang Biology (unlisted), Andon Health Co.Ltd(002432) and Zhejiang Orient Gene Biotech Co.Ltd(688298) (Siemens Medical authorized supplier).
Among them, Andon Health Co.Ltd(002432) , 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 pet" in the two months near the end of 2021.
On November 7, 2021, Andon Health Co.Ltd(002432) issued an announcement, "On the morning of November 6, 2021 (Saturday), Beijing was informed that the iHealth (Labs Inc), the US subsidiary of iHealth, was authorized by the US Food and Drug Administration (FDA). The self testing OTC Kit (colloidal gold immunochromatography) was used to obtain emergency use authorization (EUA). , which can be sold in the United States and countries that recognize the U.S. EUA during the U.S. public health emergency ".
This announcement opened the prelude to its soaring.
since the covid-19 self-test OTC kit was first disclosed on Andon Health Co.Ltd(002432) November 7, 2021 and was authorized by the U.S. FDA and EUA, as of January 12, Andon Health Co.Ltd(002432) has obtained 25 trading boards, with a cumulative increase of an amazing 937%.
Since then, Andon Health Co.Ltd(002432) has repeatedly answered questions about the "covid-19" test kit on the interactive easy platform, adding a fire to its soaring market.
Andon Health Co.Ltd(002432) the covid-19 antigen home self-test OTC kit is mainly sold through the independent brand of ihealth, an American subsidiary with a shareholding of 70.46%. The sales channels are independent website + Amazon, government orders and commercial customers.
According to the disclosure, Andon Health Co.Ltd(002432) has received 47.43 million government orders from Massachusetts, California, New York, Washington, D.C., Washington, Louisiana, Maryland and Oregon as of December 27, 2021. At present, 8.82 million people have been shipped and $62.55 million (including advance payment) has been received, The outstanding order amount is US $174.6 million. The sales collection amount of commercial customers is USD 36.19 million, and the sales amount of the company's website and Amazon in the United States is USD 68.35 million.
In addition to making the market pay attention to the orders on hand, Andon Health Co.Ltd(002432) 's production capacity makes the market daydream.
According to the production capacity of the kit, Andon Health Co.Ltd(002432) said in an investigation conducted by Huaan Fund, Huatai Bairui, Wanjia fund and other institutions on December 29, "The company's current monthly production capacity is 100 million people. It is estimated that by the beginning of 2022, the production capacity will increase to 200 million people per month. The actual production capacity expansion progress 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 Omicron mutant virus outside China has added fuel to the already hot Andon Health Co.Ltd(002432) market.
Andon Health Co.Ltd(002432) said on January 7 that on January 5, 2022 Beijing time, it received the performance test report of the Radx project of the National Institutes of health arranged by the U.S. FDA on the domestic self-test OTC kit of ihealth covid-19 antigen against Omicron mutant virus. The report showed that ihealth kit detected 100% of Omicron active virus samples with a maximum CT value of 21.59 (n = 5).
On January 10, Andon Health Co.Ltd(002432) further disclosed through the investor relations activity record form, and submitted the proposal on using family self-test box to realize Omicron covid-19 epidemic prevention 1 + 1 to Tianjin epidemic prevention and control headquarters. Relevant departments in Tianjin are studying the company's plan.
On January 12, Andon Health Co.Ltd(002432) disclosed the progress of major contracts and orders: the cumulative amount of orders and contracts between ihealth, a U.S. subsidiary producing covid-19 self-test OTC kit, and the Department of health of New York state was 185 million US dollars (about 1.180 billion yuan), The cumulative amount of orders with the Executive Office of the Federal Department of health and human services in Massachusetts was US $148 million (about RMB 944 million).
The two orders and contracts totaled RMB 2.124 billion, equivalent to 2.6 times of the revenue (RMB 790 million) in the first three quarters of Andon Health Co.Ltd(002432) 2021.
However, although there is strong demand for the kit outside China and Andon Health Co.Ltd(002432) has also received relevant orders, the extent to which Andon Health Co.Ltd(002432) can boost its performance with the help of this "going to sea" business remains to be verified by time.
The 21st Century Business Herald reporter found that ihealth, a remarkable Andon Health Co.Ltd(002432) U.S. subsidiary, was still at a loss in 2020, with a net profit of -78.9257 million yuan.
Andon Health Co.Ltd(002432) its own performance is not optimistic. After continuous losses from 2016 to 2019, it did not become positive until deducting non net profit of RMB 248 million in 2020.
In the first three quarters of 2021, Andon Health Co.Ltd(002432) achieved revenue of 790 million yuan, a year-on-year decrease of 50.82%; The net profit deducted from non profit was -24.775 million yuan, a year-on-year decrease of 106.89%.
After the high-profile release of information, Andon Health Co.Ltd(002432) has received the attention letter from Shenzhen Stock Exchange four times, asking whether the company selectively disclosed some information to hype the stock price.
In contrast, the "newcomers" Zhejiang Orient Gene Biotech Co.Ltd(688298) in China's capital market, which just landed on the science and innovation board in February 2020, are much lower key.
In December 30, 2021, Zhejiang Orient Gene Biotech Co.Ltd(688298) announced that the SIEMENS FDA self testing reagent of SIEMENS healthcare, a wholly owned subsidiary of the United States Heng Kang Biotechnology Co., Ltd., obtained the emergency authorization of FDA EUA in Beijing time December 30, 2021. It can be sold in the US public health emergency period and in the US / EUA countries / regions. The subsidiary Hengjian is the designated authorized supplier of the self-test reagent.
However, for the impact of the approval of the test agent, Zhejiang Orient Gene Biotech Co.Ltd(688298) only said that "the future sales performance of the product in the United States mainly depends on the sales capacity and orders of Siemens Medical in the United States... At present, it is impossible to predict the impact on the company's future operating performance".
Zhejiang Orient Gene Biotech Co.Ltd(688298) is mainly engaged in in vitro diagnostic products, covering POCT rapid diagnosis platform, molecular diagnosis platform and liquid biochip platform. At present, the revenue and profit mainly come from POCT rapid diagnostic reagent, which is mainly used in business fields such as infectious disease detection (including covid-19 virus detection series products), drug detection, tumor marker detection, myocardial marker detection, eugenics and upbringing detection, and hundreds of 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 Zhejiang Orient Gene Biotech Co.Ltd(688298) securities affairs department to learn more about covid-19 test agent, but no one answered the phone.
harvest four "20cm" rising limit anxiu creatures, with a long layout
Asahi bio, which harvested four "20cm" trading limits, has been focusing on the R & D, production and sales of in vitro diagnostic products since its establishment in 2008. It is obviously more prepared in the layout of covid-19 detection reagent, and has been certified in many places.
In fact, Asahi biology mentioned in its prospectus (Registration draft) at the end of 2020 that the covid-19 virus detection reagent (immunochromatography) developed by the company has been sold to overseas markets since March 2020. By the end of 2020, the cumulative sales revenue has reached 986 million yuan, driving the company's revenue of 1.199 billion yuan and net profit of 649 million yuan in 2020, with a year-on-year increase of 471.86% and 1091.96% respectively; From January to June 2021, the cumulative sales revenue was RMB 363 million, driving the company's revenue of RMB 494 million and net profit of RMB 202 million in the first half of 2021, with a year-on-year increase of 60.59% and 17.68% respectively.
As of the signing date of the prospectus, Asahi biology said, "covid-19 antibody detection reagent products have completed EU CE certification, Canada MDL certification and US FDA class C application, and covid-19 virus antigen detection reagent products have completed Canada MDL certification and EU CE certification".
In December 27, 2021, An Xu announced further biological products, New Coronavirus antigen nasal cavity detection reagent (self testing) has recently obtained the EU CE certification.
This means that company's covid-19 antigen self-test reagent product (valid until May 26, 2024) and covid-19 antigen nasal detection reagent (self-test) have obtained EU CE certification, but the certification time is relatively late.
Meanwhile, released a new update on the detection of New Coronavirus mutant Omicron (Omicron) in December 3rd, according to the official account of the An Xu virus. "The laboratory evaluation just completed shows that the detection sensitivity of the detection kit produced by our company for the recombinant antigen of the mutant virus Omicron (Omicron) is not different, that is, the detection effect of the kit on the mutant virus Omicron (Omicron) is not affected, and the verification of the clinical samples and strains of the mutant virus Omicron (Omicron) is in progress.".
Recently, an Xu biology was also reported by the media that due to the great increase in the demand for covid-19 detection reagent products, "students were recruited from vocational schools and some temporary workers were recruited to catch up with the work".
In this regard, on January 11, an Xu biology issued a change announcement, saying that "after the company's self-examination, relevant reports recently mentioned its on-site visit to the company. The recruitment of temporary workers and interns belongs to the normal needs of the company's operation, and there has been no significant change. In addition, near the Spring Festival, most of the division of labor return home in advance".
At the same time, an Xu biology announced the performance forecast for the whole year of 2021. It is estimated that the net profit attributable to the parent company in 2021 will be 658 million yuan to 790 million yuan, with a year-on-year increase of 1.41% to 21.69%.
covid-19 of a share detects "sailors" one after another
Although covid-19 self-test reagent of 12 enterprises has been authorized by FDA and EUA for emergency use, and the market competition is fierce, it can not resist more A-share listed companies to join the team.
"our company's covid-19 testing products are mainly sold in Europe, Southeast Asia and other places, and have obtained the EU CE certification. The company's covid-19 testing products are ready to apply to the US FDA for certification." On January 12, the 21st Century Business Herald reporter learned from Medicalsystem Biotechnology Co.Ltd(300439) relevant people.
in addition, Medicalsystem Biotechnology Co.Ltd(300439) the above person said, "at present, the company's covid-19 testing product registration certificate in China is still being registered, and the company's covid-19 products are only sold overseas.".
Coincidentally, Hangzhou Biotest Biotech Co.Ltd(688767) replied to investors\' questions in early December 2021, "In June 2020, the company's covid-19 antibody detection reagent product obtained the EUA authorization from the U.S. FDA. In September 2020, the covid-19 antigen family self-test reagent obtained the EU CE certification. After obtaining the certificate, the company actively expanded the overseas market... the company's covid-19 antigen self-test product is in the process of applying for the U.S. FDA certification, and will fulfill the obligation of information disclosure in time after obtaining the certificate." 。
another A-share listed company Guangzhou Wondfo Biotech Co.Ltd(300482) 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 covid-19 detection reagent has 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 covid-19 business realized a revenue of about 800 million yuan, most of which came from the sales contribution of covid-19 antigen self-test products in overseas markets."
according to incomplete statistics of the 21st Century Business Herald reporter, in addition to Guangzhou Wondfo Biotech Co.Ltd(300482) , Hangzhou Biotest Biotech Co.Ltd(688767) , Beijing Hotgen Biotech Co.Ltd(688068) , Getein Biotech Inc(603387) , Daan Gene Co.Ltd(002030) , Shenzhen Yhlo Biotech Co.Ltd(688575) , Dian Diagnostics Group Co.Ltd(300244) , covid-19 self-test kits of ten enterprises have also been approved abroad.
Many A-share companies have deployed overseas, and there is no lack of covid-19 testing business to boost the company's performance.
Just a few days ago, Beijing Hotgen Biotech Co.Ltd(688068) released the performance forecast for 2021. It is estimated that the net profit attributable to the parent company will reach 2 billion yuan to 2.35 billion yuan in 2021, with a year-on-year increase of 1684.65% to 1996.97%.
Beijing Hotgen Biotech Co.Ltd(688068) said, "In the first half of 2021, the company's New Coronavirus antigen detection kit was obtained from the German Federal Institute of drugs and medical devices (BfArM). Certification for home free testing can be sold in supermarkets, pharmacies and Internet stores in Germany, and foreign trade orders have increased explosively; In the second half of this year, self testing registration / filing of major European economies such as EU CE, British MHRA and French ANSM was carried out by New Coronavirus antigen detection kits. Especially in the fourth quarter, the COVID-19 virus was affected by delta virus and the mutant of COVID-19. As a result, the demand for covid-19 antigen detection reagent has increased significantly, resulting in a sharp increase in the income of overseas covid-19 detection reagent ".
In addition, up to now, covid-19 (2019-ncov) antigen detection kit (colloidal gold method) (self-test version) has obtained MDA certification from the Ministry of health of Malaysia and CE certification from the European Union, and has completed Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) registration / filing in MHRA of the United Kingdom, sm of Estonia, STM of Finland, basg of Austria and FMZ of Bosnia and Herzegovina. It is expected that the annual net profit will be RMB 1.3 billion-1.5 billion in 2021, A year-on-year increase of 177.23% - 219.88%.
Another related company Guangdong Hybribio Biotech Co.Ltd(300639) (300639. SZ) expects to achieve a net profit of 800 million yuan to 860 million yuan in 2021, with a year-on-year increase of 120.59% - 137.14%.
For the continuation of the overseas epidemic, Ping An Securities said it would drive the demand for reagents, and the sales of covid-19 testing reagents are expected to increase, or bring performance flexibility to relevant enterprises.
However, some people from relevant companies pointed out to the 21st Century Business Herald reporter, "although many enterprises are applying for FDA's EUA authorization, the process will take several months, including clinical test application, reagent clinical test, providing clinical test report, etc., so it still takes time for subsequent enterprises to be approved."
In a few months, the development of the virus and the market situation of covid-19 detection reagent will change, which may also have an impact on the sea effectiveness of these enterprise products.
