Since the end of last year, the new coronavirus variant, Aomi Kerong, has continued to wreak havoc around the world. AS A MORE CONTAGIOUS AND INSID VARIANT, OMIKERON HAS CAUSED 130 MILLION CONFIRMED CASES AND 500,000 DEATHS WORLDWIDE IN THE TWO AND A HALF MONTHS IT WAS NAMED.
In this context, the detection of specific variants of Ami Kerong and vaccine products have received great attention from the capital market. An A-share medical device company even took advantage of this to soar to the ranks of demon stocks.
At present, the domestic new crown pneumonia epidemic shows a situation of local scattered occurrence, nucleic acid testing has become a daily need for residents to travel and travel, but the gathering of people in the nucleic acid testing queue is also very likely to lead to cross-infection, so independent new crown testing products seem to have become a better solution. So, what are the technical routes of the new crown self-test, and what are the advantages compared with centralized nucleic acid detection? Is the accuracy of the test results guaranteed, and is it possible to open up the domestic market space in the future?
Jiu'an Medical, standing on the cusp of the wind
On November 8, 2021, Jiuan Medical, a medical device R&D and manufacturing listed company, announced that the subsidiary's NEW CROWN antigen home self-test OTC kit (colloidal gold immunochromatography method) has been authorized for emergency use (EUA) by the U.S. Food and Drug Administration (FDA) and can be sold in the United States and countries that recognize the U.S. EUA during the U.S. public health emergency. Two weeks later, Jiuan Medical hit the iron while it was hot and disclosed on Interactive Easy that the above-mentioned self-test OTC kits have been sold locally by subsidiary iHealth USA to the C-end and B-end at the same time, and the company is actively engaging and following up the orders of users from all sides.
After the news was released, the stock price of Jiuan Medical rose sharply. From November 8, 2021 to January 17, 2022, Jiuan Medical's stock price started from 6.39 yuan per share and rose all the way to 82.81 yuan per share, and in these two months, Jiuan Medical's stock price rose by 1196%. After that, although it touched the drop limit several times, it has still accumulated 32 up and down boards, the latest stock price is 66.8 yuan / share, and the total market value is nearly 32 billion yuan.
After several consecutive boards, Jiuan Medical has also issued risk warning announcements, and the Shenzhen Stock Exchange has also issued four letters of concern to Jiuan Medical to express the concerns of the regulatory authorities on the compliance, information disclosure, stock price speculation and other issues of product expression on the interactive platform.
If the previous letters of concern were for the purpose of prompting, then the latest regulatory letter confirms that Jiuan Medical has clearly violated the relevant information disclosure regulations.On February 22, the Shenzhen Stock Exchange said in its regulatory letter to Jiuan Medical that during the continuous stock price change, the company's reply on the interactive platform and the investor relations activity record sheet published on it were inaccurate and incomplete many times.
Just a few days ago, Liu Yi, chairman and general manager of Jiuan Medical, and Wu Tong, secretary of the board of directors, were just taken by the Tianjin Securities Regulatory Bureau to supervise the conversation. The reason is that jiuan medical disclosed that "100% of the Omicron active virus samples with a maximum CT value of 21.59 (n=5) were detected in the experiment" was confirmed to be selective disclosure of some of the successful test results, and all the experimental results including the "sample positive detection rate when the CT value was greater than 21.59" were not fully disclosed.
Founded in 1995, Jiuan Medical is an innovative technology enterprise focusing on the research and development and production of health electronic products and intelligent hardware. On June 10, 2010, Jiuan Medical was listed on the Shenzhen SME Board (stock code 002432).
The subsidiary iHealth that appeared above is the independent innovation brand "iHealth" created by Jiuan Medical in the year of listing, which has successively launched personal health wearable devices covering blood pressure, blood sugar, blood oxygen, ECG, heart rate, weight, body fat, sleep, sports and other fields. In September 2017, iHealth received a strategic investment of $25 million from Xiaomi Technology Group and became a Xiaomi Ecosystem Partner. At present, iHealth has set up subsidiaries in Silicon Valley in the United States, Paris, Beijing, and Singapore, corresponding to the above-mentioned sales of new crown antigen home self-test OTC kits by the American subsidiary.
In terms of performance, in the first half of 2020, Jiuan Medical's revenue was 1.041 billion yuan and net profit was 315 million yuan, ranking 21 and 24 respectively among the 71 medical device companies that disclosed financial reports in A shares, ranking in the middle and upper reaches. In the first three quarters of 2021, Jiuan Medical's revenue was 790 million yuan, down 50.8% year-on-year, and net profit was 50.13 million yuan, down 86.19% year-on-year.
As of now, Jiuan Medical's 2021 four-quarter report and annual report have not yet been released. The latest announcement shows that the contract revenue of iHealth kit products of Jiuan Medical Subsidiary has approached 3 billion yuan, which may bring strong support to its performance in the first quarter of 2022.
Domestic new crown self-test is difficult to become the mainstream
The results of the British human anti-virus experiment show that some patients have detoxification ability before the PCR test can detect positive; and the process of queuing up to brush nucleic acid itself is also an exposure, in order to prevent cross-infection, some people have proposed that residents can first test at home, and then go to the hospital for further testing after the positive risk of the result.
In January this year, Jiu'an Medical, mentioned above, submitted the "Proposal on Using Family Self-Test Boxes to Achieve 1+1 Covid-1 Epidemic Prevention in Aomi Kerong" to the Tianjin Municipal Epidemic Prevention and Control Command, proposing to use a combination of "nucleic acid test (diagnosis) + family self-test (screening)" to block the spread of Aomi Kerong, causing public concern about the family self-test kit.
It is understood that The coronavirus is distinguished from other viruses by its unique RNA genome and the protein corresponding to the viral gene, Based on this, it was also derived Nucleic acid testing and Antigen testing Two virus detection methods 。In April 2021, the National Health Commission issued the "Diagnosis and Treatment Plan for Pneumonia Infected by novel coronavirus (Trial Eighth Edition)" that a positive nucleic acid test for the new coronavirus is the primary criterion for confirming the diagnosis.
Nucleic acid testing is far more sensitive and specific than antigen detection, and can also detect COVID-19 patients at a later stage.However, at present, common nucleic acid detection requires high-value instruments and equipment, cumbersome operation procedures, and the testing is concentrated in major hospitals, third-party testing centers or laboratories. The instrument is expensive, the resources are limited, and the operation professional requirements are high, which is not conducive to obtaining the test results immediately at the grass-roots level and on-site testing points.
Antigen detection can be achieved through supporting reagents and portable instruments to achieve rapid diagnosis, easy to operate, convenient,
However, its detection sensitivity is significantly lower than that of nucleic acid detection, and usually only strong positive samples can be detected.If the sample does not contain a certain amount of virus, there will be a certain probability of false negatives, and its detection time for new crown patients is often later than nucleic acid testing.
Since there is no mandatory nucleic acid testing abroad, most overseas residents use this test product based on microfluidic POCT diagnostic technology for home self-testing, and take antiviral drugs or use physical therapy to intervene in the new crown virus.
According to data from the China Business Industry Research Institute, the size of China's nucleic acid testing market in 2021 was 13.6 billion yuan, an increase of 12.4% year-on-year. From the perspective of market share distribution, China's nucleic acid testing market is mainly based on nucleic acid testing of infectious diseases, accounting for 44% of the overall market. Boosted by the epidemic, the growth rate of China's nucleic acid testing market has led the world in the past three years. It is expected that the market size will further grow to 14.6 billion yuan in 2022, of which the market size of the new crown virus nucleic acid testing ≤ 6.4 billion yuan.
For the development trend of new crown nucleic acid testing and the popularity of self-testing products, Yang Shixian, partner of Xingliang Investment, said,
COVID-19 testing First with The evolution of the COVID-19 pandemic and COVID-19 drugs current The R&D process is closely related"Based on the high infectivity and low toxicity of the Omiljun strain, if there is no cross-fusion mutation of various strains, theoretically, the toxicity of the new crown virus is getting weaker and weaker." At present, many European and American countries have gradually unsealed. ”
secondly Covid-19 nucleic acid detect Whether it will continue to be carried out also and mainland epidemic prevention and control request Closely relatedRecently, the mainland has also stepped up the research and development of small molecule new crown drugs, and Pfizer's new crown oral drugs have also been urgently approved in China. If the virus does not mutate in the short term and the epidemic is effectively controlled after the emergence of new crown drugs, the amount of nucleic acid testing for the new crown virus may drop significantly. However, Yang Shixian stressed that in the short term, the new crown nucleic acid testing is still a relatively effective means of detection, and he predicts that the price of nucleic acid testing is likely to continue to fall.
"In the future, as the new crown nucleic acid testing in the mainland is no longer a mandatory requirement, it may be possible to release the new crown self-test and self-medication." But it should be noted that
Compared with microfluidics and antigen detection, nucleic acid detection is still the gold standard for the detection of new coronavirus in mainland China. If small molecule drugs that can effectively inhibit the virus do not appear, the effectiveness of the new crown self-test product and the authority of the results are difficult to be recognized. Even if there is a new crown drug, such prescription drugs cannot be purchased directly in pharmacies like OTC drugs, which also means that the use of new crown self-test products will not be very large. ”