Securities code: Sansure Biotech Inc(688289) securities abbreviation: Sansure Biotech Inc(688289) Announcement No.: 2022026 Sansure Biotech Inc(688289)
With regard to the announcement of voluntary disclosure that the company’s relevant testing products have obtained EU CE certification, the board of directors and all directors of the company guarantee that there are no false records, misleading statements or major omissions in the contents of this announcement, and bear legal responsibility for the authenticity, accuracy and integrity of its contents in accordance with the law.
Important content tips:
Product competition risk: in addition to the relevant products of Sansure Biotech Inc(688289) (hereinafter referred to as “the company”) obtaining the EU CE certification, there are also relevant products of other companies supplied to the market, and there are many methods for the detection of covid-19 pneumonia, so the company’s products may face the market competition risk of similar products or other detection products.
Uncertainty about the impact on profits: up to now, the company’s relevant products have just obtained EU CE certification. Affected by many factors such as overseas epidemic development and control, selection of detection methods, overseas marketing and customer recognition, the product sales and profit contribution are uncertain, and it is impossible to predict the specific impact of the above products on the company’s future operating performance.
The company’s product New Coronavirus (SARS-CoV-2) rapid antigen detection kit (immune chromatography) (English SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay)) has recently obtained the EU CE certification. The details are announced as follows:
1、 Product registration
Certificate No. certificate type product name application field certificate validity
Qualitative detection of human nasal swab samples by sars-cov-2 rapid
Sars-cov-2 antigen in 1434
EC Design- Antigen Test
IVDD – (immunochromatography (Ag) nucleocapsid protein, with 2025-5-27 examination
0852022
Assay) for home use.
2、 Related products involved
Approved subject Sansure Biotech Inc(688289)
Product name New Coronavirus (SARS-CoV-2) rapid antigen detection kit (immunochromatography)
This product is a disposable rapid immunoassay reagent judged by the naked eye. It is suitable for the qualitative detection of sars-cov-2 antigen (Ag) nucleocapsid protein in human nasal swab samples suspected of covid-19 symptoms of the intended use. This reagent is authorized to be used for home testing for people aged 17 or above. Children under 17 should be collected and tested with the help of adults.
Scope of use: EU countries and countries that recognize EU CE certification
Service life: May 27, 2025
The company’s CE certified New Coronavirus (SARS-CoV-2) rapid antigen detection kit (immunochromatography) uses immunochromatographic technology to detect SARS-CoV-2 antigen (Ag) nucleocapsid protein in human nasal swabs in a relatively short period of time, and complete the result interpretation with the naked eye. It is simple and convenient, without instruments, and is suitable for rapid detection of multiple scenes. After obtaining the EU CE certification, the above products of the company can be sold in EU countries and countries that recognize the EU CE certification. Therefore, the company can further expand the overseas epidemic prevention and control business, and the company can further expand the international sales of the above products.
3、 Risk tips
1. Product competition risk
In addition to the EU CE certification of the company’s products, there are also relevant products of other companies to supply the market, and there are many methods for the detection of covid-19 pneumonia, so the company’s products may face the market competition risk of similar products or other detection products. 2. The impact on profits is uncertain
Up to now, the company’s relevant products have just obtained EU CE certification. Affected by various factors such as overseas epidemic development and control, selection of detection methods, overseas market promotion and customer recognition, the product sales and profit contribution are uncertain, and it is impossible to predict the specific impact of the above products on the company’s future business performance.
Please pay attention to investment risks.
It is hereby announced.
Sansure Biotech Inc(688289)
Board of directors April 14, 2022
