Securities code: 002432 securities abbreviation: Andon Health Co.Ltd(002432) Announcement No.: 2022-016
Announcement on the subsidiary ihealth covid-19 antigen rapid detection POC professional kit product obtaining the authorization of FDA and EUA
The company and all members of the board of directors guarantee that the contents of the announcement are true, accurate and complete, and shall be jointly and severally liable for false records, misleading statements or major omissions in the announcement. Andon Health Co.Ltd(002432) (hereinafter referred to as “the company”) was established in 2022 Beijing time
On the morning of January 15th (Saturday), it was learned that New Coronavirus (SARS-CoV-2) antigen, which was authorized by the US Food and Drug Administration (FDA), and iHealth Labs Inc. of the US subsidiary (hereinafter referred to as “iHealth America”), quickly detected POC (Point Of Care) professional version of the test kit (colloidal gold immunochromatography) for emergency use authorization (EUA). And received the authorization letter sent by the U.S. Food and Drug Administration (FDA) to ihealth America. After obtaining the U.S. emergency use authorization (EUA), the product can be used in the United States and countries / regions that recognize the U.S. FDA EUA during the U.S. public health emergency state. The details are hereby announced as follows:
1、 Product related information
Serial No. product name EUA No. intended use
1 ihealth eua210536 this product is mainly used for rapid and qualitative test in vitro
Covid-19 determination of new coronal in human anterior nasal swab samples
Antigen virus (sars-cov-2).
Rapid Test
Pro
Ihealth USA, a subsidiary of the company, has accumulated experience in IVD and FDA applications, following 2021
On November 6, 2003, it was authorized by the U.S. FDA EUA for the ihealth covid-19 antigen home self-test OTC kit
Now we have obtained the professional POC kit for ihealth covid-19 antigen rapid detection (ihealth covid-19
Anti rapid test pro) is authorized by the U.S. FDA EUA. The product must be used in accordance with the product instructions,
The professional medical staff or the personnel who can skillfully use the kit in the point of care scene shall collect the front nasal swab samples for test operation, and the results can be obtained in 15 minutes, which can be used by the professional medical staff and the personnel who can skillfully use the kit in the point of care scene in covid-19
It is used in the screening of pneumonia to help the epidemic prevention and control.
2、 Impact on the company
The product enriches the company’s covid-19 antigen detection product line through emergency use authorization (EUA), which can contribute to public health and epidemic prevention to a greater extent, provide professional covid-19 virus detection solutions for public health and epidemic prevention, and may bring relevant sales revenue and performance to the company in the future.
3、 Risk tips
The overseas sales of ihealth covid-19 antigen rapid detection POC professional kit of the company’s U.S. subsidiary is closely related to the development of the epidemic. Due to the unpredictability of the epidemic development, the promotion of vaccination plan, the research and development of specific drugs, the validity period of product emergency use authorization (EUA), as well as the development and change of the market, After the product obtained the US emergency use authorization (EUA), the company is unable to predict the impact of the product on the company’s operating revenue and performance in the future.
The company considers it necessary to give risk tips to the majority of investors, as follows (including but not limited to):
1. Uncertainty risk of epidemic development in the United States: the demand for the company’s antigen home self-test kit products is directly related to the development of epidemic situation in the United States. Virus variation, vaccination and the introduction of covid-19 drugs all have an impact on the development of epidemic situation. Therefore, the development of epidemic situation in the future has strong uncertainty, This uncertainty may greatly affect the demand of kit products;
2. Uncertainty risk of market competition: at present, there are 21 companies (including ihealth USA) that have obtained FDA EUA authorization for covid-19 test products in POC use scenarios. It can not be ruled out that more companies will obtain such authorization and enter the market to sell similar kit products in the future, The market competition situation may impact the existing market share and product price of a single enterprise;
3. Exchange rate fluctuation risk: the company’s kit products are settled in US dollars. With the development of sales, the number of foreign currencies held by the company may further increase. In view of the uncertainty of exchange rate fluctuations, the company will adjust the product sales price accordingly according to the exchange rate changes, and will consider locking the exchange rate by signing relevant agreements with banks to prevent the risk of large exchange rate fluctuations. However, if the fluctuation range is large in the short term, the company may have exchange losses, which will have an adverse impact on the company’s operating performance;
4. Logistics and transportation risk: due to the epidemic situation in the United States, the current shortage of transport capacity in air and sea channels continues, port congestion and serious backlog of goods. If the shipped goods cannot be picked up in time, it will have an adverse impact on product sales;
5. Quality risk: in the case of mass production, the batches of individual products may have quality problems, leading to the risk of return or even recall.
Please pay attention to risks and invest rationally. It is hereby announced.
Andon Health Co.Ltd(002432) board of directors January 17, 2022
