1. Securities code: 002432 securities abbreviation: Andon Health Co.Ltd(002432) Announcement No.: 2022-013 Andon Health Co.Ltd(002432) announcement on the reply to the letter of concern of Shenzhen Stock Exchange. The company and all members of the board of directors guarantee that the contents of the announcement are true, accurate and complete, and bear joint and several liabilities for false records, misleading statements or major omissions in the announcement. On January 12, 2022, the board of directors of Andon Health Co.Ltd(002432) (hereinafter referred to as the “company”) received the letter of concern on Andon Health Co.Ltd(002432) issued by the management department of listed companies of Shenzhen Stock Exchange (hereinafter referred to as “Shenzhen Stock Exchange”) (company department concern letter [2022] No. 12) (hereinafter referred to as “concern letter”), which the company attaches great importance to, Immediately checked the issues listed in the letter of concern one by one, and now the reply to the letter of concern is as follows: 1 Explain the specific meaning of the CT value of virus samples in this experiment, and explain the overall CT value distribution of Omicron virus (if applicable). Reply: CT value is the abbreviation of English cycle threshold. It is the unit in quantitative PCR (nucleic acid) detection. The specific meaning is: the number of cycles experienced by the fluorescent signal in each reaction tube when it reaches the set domain value. In this experiment, the lower the CT value, the smaller the number of cycles experienced when representing the set domain value, and the higher the concentration of the sample to be tested. According to the information on the CDC website of the United States, Omicron virus was listed as a concern variant (VOC) by the sars-cov-2 inter agency group (SIG) of the U.S. government on November 30, 2021. At present, the distribution of CT value of the variant virus in the population has not been published. 2. Explain that the announcement of your company only discloses the test results of four samples with CT value less than or equal to 21.59, but does not disclose the test results of seven samples with CT value greater than 21.59, whether there is a situation that the positive detection rate of all samples is confused with the positive detection rate of some samples to mislead investors, and whether the disclosure of the test results of the experimental report in the above announcement is complete, Whether there is selective disclosure of some information to hype the stock price, and explain the reasons. Reply: the announcement of the company disclosed that “100% of the Omicron active virus samples with a maximum CT value of 21.59 (n = 5) were detected by ihealth kit in the experiment”, in which “maximum” means that samples less than or equal to 21.59 can be detected 100%, and samples greater than 21.59 cannot be detected 100%. In order to avoid misunderstanding, the company specially quoted the public statement officially issued by the U.S. FDA in the announcement, which described the effectiveness of covid-19 antigen detection kit products for detecting Omicron variant virus on its official website: FDA is cooperating with NIH in Radx project to use samples of patients infected with Omicron variant virus, To study the performance of antigen detection kit. Radx has recently evaluated some antigen detection kits in detecting active virus samples of infected patients through preliminary research, which is the best way to evaluate its real detection performance in a short time. Early data show that the antigen detection kit can detect Omicron variant virus, but its sensitivity may be reduced. FDA continues to authorize the use of these tests in accordance with the instructions in the authorization label, and individuals should continue to use them in accordance with the instructions contained in the tests. Antigen tests are usually less sensitive and less likely to detect very early infections than molecular tests. In the process of following FDA’s long-term rapid detection recommendations, if a person’s antigen test result is negative but is suspected to have covid-19, such as symptoms or high possibility of infection due to exposure, subsequent molecular testing is important to determine covid-19 infection. If a person’s antigen test is positive, they should isolate themselves and seek follow-up care from a health care provider to determine the next steps. The above contents of the company’s announcement specifically emphasize the possible reduction of antigen detection sensitivity. The company will strengthen the control over the integrity of the wording of the announcement in the future, but the company has no behavior and motivation to hype the stock price through information disclosure, and there has been no change in the stock price for three consecutive trading days since the date of the announcement. 33. Explain whether your company’s announcement that “ihealth kit detected 100% of Omicron active virus samples with a maximum CT value of 21.59 (n = 5)” is consistent with the actual results of the experimental report, and whether there is a contradiction with the FDA’s statement that “early data show that antigen detection kit can detect Omicron variant virus, but its sensitivity may be reduced”, Further explain whether the relevant statements in your company’s announcement are accurate and misleading, and explain the reasons. Reply: according to the data in the test report, there are 11 concentrations of CT values in the experiment, and each CT value concentration has a total of 5 samples. When the CT values are 19.35, 19.78, 20.86 and 21.59, all 5 samples are positive, so it is 100% detected. However, when the CT values were 22.86, 23.87, 24.93, 25.96, 26.91, 27.72 and 28.81, not all of the five samples were detected. Therefore, the statement that “ihealth kit detected 100% of Omicron active virus samples with a maximum CT value of 21.59 (n = 5)” was consistent with the actual results of the experimental report, and the announcement was accurate. In order to avoid misunderstanding, the company specially quoted the public statement officially issued by the U.S. FDA in the announcement, which described the effectiveness of covid-19 antigen detection kit products for detecting Omicron variant virus on its official website: FDA is cooperating with NIH in Radx project to use samples of patients infected with Omicron variant virus, To study the performance of antigen detection kit. Radx has recently evaluated some antigen detection kits in detecting active virus samples of infected patients through preliminary research, which is the best way to evaluate its real detection performance in a short time. Early data show that the antigen detection kit can detect Omicron variant virus, but its sensitivity may be reduced. FDA continues to authorize the use of these tests in accordance with the instructions in the authorization label, and individuals should continue to use them in accordance with the instructions contained in the tests. Antigen tests are usually less sensitive and less likely to detect very early infections than molecular tests. In the process of following FDA’s long-term rapid detection recommendations, if a person’s antigen test result is negative but is suspected to have covid-19, such as symptoms or high possibility of infection due to exposure, subsequent molecular testing is important to determine covid-19 infection. If a person tests positive for antigen 4, they should isolate themselves and seek follow-up care from a health care provider to determine the next steps.
The above contents published by the FDA are consistent with the experimental report data of our ihealth kit. The contents announced by the company are consistent with the above contents and are not misleading statements. 4. Supplementary disclosure of the details of the experiment, including but not limited to the sample selection method of the experimental group and the control group, the experimental process, the positive detection rate of samples in all experimental groups, the reliability of experimental results, etc., and in combination with the experimental sample size, experimental methods and other factors, explain whether the experimental results can represent the overall situation, The experimental results have a supporting relationship with the sensitivity and specificity of ihealth kit for detecting Omicron virus. On this basis, the experimental results are fully risk prompted. Reply: the experiment was carried out in the Radx project of the cooperation between FDA and the National Institutes of Health (NIH). The experimental methods and testing institutions are designated by Radx. The details of the experiment are as follows: experimental group and control group: the experimental group used ihealth kit to test the Omicron mutant, and set the quality control of three groups of negative samples as the reliability control. Sample selection method: first, a sample pool was created using a live clinical sample (RCS) confirmed as Omicron by sequencing. A certain amount of samples were extracted with RNA (RNA) separation kit to determine the circulation threshold (CT) of sars-cov-2 virus nucleocapsid gene N2 of each sample. In the experiment, samples with virus N2 CT ≤ 21 were collected, and then aliquots of the initial sample pool were continuously diluted in negative nasal lotion to obtain a dilution series with one CT value as interval, covering CT values of 19-29. 5 the nucleocapsid protein concentration was determined by the quanterix simoa sars-cov-2 N protein antigen test. Experimental process: use ihealth kit to detect all the samples prepared above. The positive detection rate of samples in the experimental group: all samples can be detected when CT value ≤ 21.59, 60% when CT value is 22.86, and can not be detected when CT value ≥ 23.87. Reliability of experimental results: during the experiment, the three groups of negative QC were all negative by ihealth kit, so the experimental results are reliable. CT value and N protein concentration take the average value of three measurements, so the expression of experimental results is accurate. In this experiment, the active Omicron virus is used in the test sample. Different from the inactivated virus, the active virus is the test sample closest to the virus state in the human body, which can more effectively represent the test situation of human samples. 11 concentration gradients were tested, and the interval of each concentration gradient was about 1 CT value, which could accurately obtain the relative sensitivity of ihealth kit. Repeated measurement of each concentration sample for 5 times can effectively improve the precision of the experiment. The above experiments only tested the sensitivity of ihealth kit products, but did not test the specificity. There is no statement about the specificity in the experimental report. Risk tip: as stated in the company’s announcement, the contents published on the FDA website: “FDA continues to authorize the use of these kits according to the instructions in the authorization label, and individual users should continue to use them according to the instructions contained in the kit products. Compared with nucleic acid detection, antigen detection is usually less sensitive than nucleic acid detection, and the possibility of detecting very early infection is also lower than nucleic acid detection. In the process of following FDA’s long-term rapid detection recommendations In, if a person’s antigen test result is negative but is suspected to be infected with covid-19 virus, such as symptoms or high possibility of infection due to exposure, it is very important to confirm whether he is infected by nucleic acid test. If a person’s antigen test results are positive, they should isolate themselves and seek follow-up care from a health care provider to determine follow-up arrangements. ” 6 to sum up, the sensitivity of antigen detection is lower than that of nucleic acid detection and cannot replace nucleic acid detection. If a person’s antigen detection result is negative but is suspected to be infected with covid-19 virus, it shall be confirmed by nucleic acid detection. 5. In combination with the answers to the above four questions, explain whether the disclosure of your company’s announcement is true, accurate and complete, whether there are misleading statements or major omissions, whether it is clear, appropriate and easy to understand, and whether it complies with the provisions of articles 2.1.1, 2.1.4, 2.1.5, 2.1.6 and 2.1.9 of the stock listing rules (revised in 2022), And explain the reasons. Reply: the company explained the relevant information of the announcement contents in the reply to the above four questions, but if you want to fully understand the above contents and announcement contents, you really need some relevant knowledge. The company uses the shortest possible wording in the announcement is also based on considering the incomprehensible problems caused by too many professional terms in the announcement, but in terms of the intelligibility and integrity of the wording, The provisions of articles 2.1.1, 2.1.4, 2.1.5, 2.1.6 and 2.1.9 of the stock listing rules (revised in 2022) really need to be strengthened and improved. Before the announcement, the company conducted and completed bioinformatics comparison and recombinant N protein comparison tests on the kit products respectively. Then, it received the test performance test report of NIH in the United States and made an announcement with reference to the contents published by FDA. The company followed a scientific and prudent attitude in the control of the above procedures, and the contents were true and reliable. However, in the future work, the listed company will strengthen the control and review of the wording of the announcement in accordance with the relevant provisions on information disclosure of listed companies, especially the provisions of articles 2.1.1, 2.1.4, 2.1.5, 2.1.6 and 2.1.9 of the stock listing rules (revised in 2022). 6. Describe the procedures to be performed for your ihealth kit to obtain emergency approval from Tianjin drug administration, explain whether the scheme proposed by your company does not comply with China’s epidemic characteristics and prevention and control strategies, and fully prompt the uncertainty and related risks. Reply: covid-19 antigen kit belongs to class III medical devices in China and is reviewed and approved by the State Drug Administration 7. The work flow is to submit an emergency approval application to the State Drug Administration. After the State Drug Administration receives the emergency approval application, the medical device product registration test shall be carried out. After the registration test, the kit shall be subject to clinical test, After the kit registration test and clinical trial, the application for review and approval of covid-19 antigen kit registration in China can be submitted in accordance with the requirements of relevant national medical device registration regulations. The State Drug Administration shall review and approve the product registration in accordance with the requirements of relevant regulations, and assess the registered product system of the manufacturer during the review process, After the product registration and the assessment of the registered product system are passed, the State Drug Administration will issue the medical device product registration certificate. collect
