Andon Health Co.Ltd(002432) (002432), which increased 14 times in three months, received a decision on administrative supervision measures.
On February 14, Andon Health Co.Ltd(002432) announced that the company recently received the decision on taking regulatory talk measures against Liu Yi and Wu Tong (hereinafter referred to as the “decision”) issued by Tianjin Securities Regulatory Bureau. According to the decision, Andon Health Co.Ltd(002432) only disclosed some successful test results on January 7, 2022, but did not disclose all the test results, and the disclosure information was incomplete. As the chairman and general manager of Andon Health Co.Ltd(002432) , Liu Yi and Wu Tong, as the Secretary of Andon Health Co.Ltd(002432) , bear the main responsibility for the integrity of the information disclosure of the company’s interim report.
Backtracking the company’s announcement, on January 7, Andon Health Co.Ltd(002432) disclosed that the company received the performance test report of the Radx project of the National Institutes of Health (NIH) on the household self-test OTC kit of ihealth covid-19 antigen against Omicron variant virus arranged by the FDA on January 5, 2022 Beijing time.
The company said the report showed that “ihealth-covid-19 antigenrapidtest detected 100% of Omicron active virus samples with a maximum CT value of 21.59 (n = 5)”.
The announcement also translated the FDA’s description of the effectiveness of covid-19 antigen detection kit products for detecting Omicron variant virus on its official website: FDA is cooperating with NIH in the Radx project to study the performance of antigen detection kit by using samples of patients infected with Omicron variant virus. Radx recently evaluated the performance of some antigen detection kits in detecting active virus samples from 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.
It is worth mentioning that on the day of the announcement, the company’s share price rose 6.05%.
Obviously, the above announcement full of professional medical terms will make ordinary investors “head big”, and the report on the FDA’s official website is “unclear”.
However, Shenzhen stock exchange is still concerned that the original English document of the performance test report of Radx project on ihealth kit reported by the company shows that there are 11 samples of Omicron active clinical virus test group in the sample pool of the experiment, and their CT values are linearly distributed between 19.35-28.81.
In the experiment, ihealth kit was used to detect each sample for 5 times. The test results showed that for the four samples with CT value less than or equal to 21.59, the 20 test results were positive (positive, the same below); For a sample with CT value equal to 22.86, the results of three tests are positive and the results of two tests are negative (negative, the same below); The 30 test results of 6 samples with CT value greater than 22.86 were negative.
Therefore, Shenzhen Stock Exchange issued a letter of concern on the above announcement of the company on January 12, asking the company to explain:
1. The specific meaning of CT value of virus samples in this experiment, and explain the overall CT value distribution of Omicron virus (if applicable).
2. The company only disclosed the test results of four samples with CT value less than or equal to 21.59, but did not disclose the reasons for the test results of seven samples with CT value greater than 21.59. Is there a situation that the positive detection rate of all samples is confused with the positive detection rate of some samples to mislead investors.
3. Whether the 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”.
On January 15, Andon Health Co.Ltd(002432) said in reply to the letter of concern: the company previously disclosed that “100% of Omicron active virus samples with a maximum CT value of 21.59 (n = 5) were detected 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%, And admitted that “the positive detection rate of all samples in the experimental group: when the CT value is ≤ 21.59, it can be detected completely, when the CT value is 22.86, it can be detected 60%, and when the CT value is ≥ 23.87, it can not be detected at all.”
The company also said in the above reply: if you want to fully understand the above contents and the contents of the announcement, 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 the intelligibility and integrity of the measures really need to be strengthened and improved.
Regulatory action! 14 times the chairman and Secretary of the “demon king” were found to have violated the provisions of the letter phi, and the major positive announcement had this problem
Disclose only some successful test results of covid-19 kit Andon Health Co.Ltd(002432) the chairman and the board secretary were punished. Insiders: the data are misleading
