Securities code: Sansure Biotech Inc(688289) securities abbreviation: Sansure Biotech Inc(688289) Announcement No.: 2022046 Sansure Biotech Inc(688289)
Announcement on voluntary disclosure that the company’s relevant testing products have obtained EU CE list a 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 according to law.
Important content tips:
Product competition risk: in addition to Sansure Biotech Inc(688289) (hereinafter referred to as “the company”), there are also relevant products of other companies to supply the market, and there are many methods for HBV, HCV and HIV testing, so the company’s products may face the market competition risk of similar products or other testing products.
Uncertainty about the impact on profits: up to now, the company’s relevant products have just obtained the EU CE list class a certification. Affected by the selection of testing methods, overseas marketing, customer recognition and other factors, 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 products hepatitis B virus nucleic acid detection kit (PCR fluorescence method), hepatitis C virus nucleic acid detection kit (PCR fluorescence method) and human immunodeficiency virus type 1 nucleic acid determination kit (PCR fluorescence probe method) recently obtained EU CE certification (ivddlista class). In the category of EU CE certification, lista products are subject to the highest degree of regulation and strict technical requirements. The verification, evaluation and audit intensity required is high, and the certification is difficult. Obtaining this certification fully reflects the company’s R & D and innovation strength, product quality and reliable performance.
The details are hereby announced as follows:
1、 Product registration
Approved subject certificate number certificate type product name application field certificate validity application scope
For quantitative detection of plasma samples
Cecert / 115 / w / E.1 EC design test certificate hepatitis B virus nucleic acid detection kit (HBV DNA in PCR fluorescence, determinable)
Detection of HBV A and B by quantitative quantity of hepatitis B virus DNA (May 26, 2025)
Fluorescence Diagnostic Kit (PCR- C、D、E、F、G、H
Cecert / 116 / w / E.1 total quality assurance system certificate
Type.
Cecert / 117 / w / E.1 EC design test certificate hepatitis C virus nucleic acid detection kit (PCR fluorescence for quantitative detection of plasma samples Sansure Biotech Inc(688289) method of EU countries) (HCV RNA in hepatitis C virus RNA quantitative can determine and approve the amount of European technology shares to detect HCV 1, 2, 3. On May 26, 2025, fluorescence diagnostic kit (PCR) of alliance CE Certification Co., Ltd-
Cecert / 118 / w / E.1 total quality assurance system certificate (type 4, 5 and 6). Country
Cecert / 119 / w / E.1 EC design test certificate human immunodeficiency virus type 1 nucleic acid assay kit is used for quantitative detection of plasma samples
(PCR fluorescent probe method) (HIV-1 RNA in human, determinable
Detection of immune deficiency virus type 1 RNA quantity HIV-1 m and N May 26, 2025
Quantitative fluorescence diagnostic kit and group o.
Cecert / 120 / w / E.1 total quality assurance system certificate (PCR fluorescence probing)
2、 Impact on the company
The three products of the company that have obtained the EU CE list class a certification mainly use the magnetic bead nucleic acid extraction technology, combined with the fluorescence real-time quantitative PCR amplification technology, which can quantitatively detect hepatitis B, hepatitis C and HIV in human blood. Through the high-precision and automatic detection scheme, the above products can accurately and efficiently detect the virus content, assist in the monitoring of clinical treatment effect, and help prevent and control major infectious diseases such as hepatitis and AIDS around the world.
In the category of EU CE certification, list a products are subject to the highest degree of regulation and strict technical requirements. The verification, evaluation and audit intensity required is high, and the certification is difficult. Obtaining this certification fully reflects the company’s R & D and innovation strength, product quality and reliable performance.
The above products of the company can be sold in EU countries and countries that recognize EU CE certification after obtaining EU CE list class a certification. The above products can meet the clinical needs. Therefore, the company’s overseas sales product category has been further expanded, which plays a positive role in the company’s sales and international business development.
3、 Risk tips
1. Product competition risk
In addition to the company, there are also relevant products of other companies to supply the market, and there are many methods for HBV, HCV and HIV testing, so the company’s products may face the market competition risk of similar products or other testing products.
2. The impact on profits is uncertain
Up to now, the company’s relevant products have just obtained the EU CE list class a certification. Affected by the selection of testing methods, overseas market promotion, customer recognition and other factors, 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 may 23, 2022
