Securities code: 688317 securities abbreviation: Shanghai Zj Bio-Tech Co.Ltd(688317) Announcement No.: 2022-004 Shanghai Zj Bio-Tech Co.Ltd(688317)
Announcement on 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 the announcement, and bear legal liabilities for the authenticity, accuracy and completeness of the contents according to law.
Shanghai Zj Bio-Tech Co.Ltd(688317) (hereinafter referred to as "company") New Coronavirus antigen detection kit (colloidal gold method), New Coronavirus neutralization antibody detection kit (ELISA), New Coronavirus neutralization antibody detection kit (colloidal gold method), New Coronavirus (SARS-CoV-2) L452R &P681R mutation detection kit were recently awarded four EU CE certification. The specific situation is hereby announced as follows: I. relevant certification
Product name certificate No. application field validity
SARS-CoV-2Antigen TP 0032-2022 New Coronavirus antigen test May 26, 2025 Detection Kit (Colloidal Gold) measurement
New Coronavirus antigen detection reagent
Box (colloidal gold method)
SARS-CoV-2 Neutralization TP 0032-2022 New Coronavirus neutralization anti Antibody Detection Kit body detection May 26, 2025
(ELISA)
Detection of neutralizing antibodies in New Coronavirus
Kit (ELISA)
SARS-CoV-2 Neutralization TP 0032-2022 New Coronavirus neutralization anti Antibody Detection Kit body detection May 26, 2025
(Colloidal Gold)
Detection of neutralizing antibodies in New Coronavirus
Kit (colloidal gold method)
Liferiver SARS-CoV-2 L452R TP 2682-2021 New Coronavirus mutation May 26, 2025 & P681R Mutations Detection point detection
Kit
New Coronavirus (SARS-CoV-2) L452R & P681R mutation detection reagent
box
2、 Related products involved
Product Name: intended use scope of the certified subject
Sars-cov-2antigen Shanghai Shanghai Zj Bio-Tech Co.Ltd(688317) department is used for the detection of new coronal European Union countries and detection kit (European Union CE gold) in nasal vestibular samples, It is used for the auxiliary diagnosis of New Coronavirus New Coronavirus antigen detection and identification.
Kit (colloidal gold method)
Sars-cov-2 Shanghai Shanghai Zj Bio-Tech Co.Ltd(688317) department is used to qualitatively detect the total neutralizing antibody of coronavirus type from new EU countries and neutralisation Antibody Technology Co., Ltd, Recognised that the European Union CE Detection Kit has not yet had an adaptive immune response to New Coronavirus (ELISA) in the near future.
Neutralizing antibodies or previous infection of New Coronavirus.
Detection kit (ELISA)
SARS-CoV-2 Shanghai Shanghai Zj Bio-Tech Co.Ltd(688317) division is used for qualitative detection of New Coronavirus neutralizing antibodies in the finger tip blood of EU countries and NeutralizationAntibody technology Limited by Share Ltd. Only the EU CE detection kit is approved to evaluate the humoral immune effect of covid-19 mRNA vaccine certified countries (colloidal gold) after full vaccination.
New Coronavirus neutralization antibody test kit (colloidal gold method)
Liferiver sars-cov-2 Shanghai Shanghai Zj Bio-Tech Co.Ltd(688317) It is used for in vitro qualitative detection of the new central European Union countries and L452R & P681R technology Limited by Share Ltd infected patients with nasopharyngeal swabs and oral approval of the EU CE Mutations Detection Kit throat swab samples of New Coronavirus certified national New Coronavirus L452R and P681R mutations available.
(SARS-CoV-2) L452R infection in New Coronavirus mutant
&Auxiliary identification and monitoring of p681r mutation detection reagent.
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3、 Impact on the company
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, which enriches the company's product types, provides more professional, high-quality and comprehensive covid-19 virus detection solutions for global covid-19 epidemic prevention and control, and further improves the company's international competitiveness, It plays a positive role in the company's expansion of overseas sales product categories and international business development.
4、 Risk tips
1. Product competition risk
In addition to the relevant certification of the company's products, the relevant products of other companies are also supplied to the market with certificates, and there are various detection methods for covid-19 pneumonia, so the company's products may face the market competition risk of similar products or other detection products.
2. Uncertain risk on profit impact
Affected by overseas epidemic development and epidemic prevention and control policies, market competition, path selection of international epidemic on technical products, product competitiveness and channel ability of the company, customer recognition and other factors, the sales and profit contribution of the above products are highly uncertain. The impact of the income of the above products in overseas markets on the company's overall income is uncertain. See the company's periodic report for the specific income in domestic and overseas markets.
3. Secondary market fluctuation risk
The company specially reminds investors to pay attention to the risk of stock price fluctuation in the secondary market, avoid following the trend of speculation, make rational decisions and invest prudently.
The company solemnly reminds investors that Shanghai Securities News, China Securities News, securities times and Securities Daily are the information disclosure newspapers designated by the company, and the website of Shanghai Stock Exchange (www.sse. Com. CN.) Specify an information disclosure website for the company. All information of the company shall be subject to the information published in the above designated media. Please pay attention to investment risks.
It is hereby announced.
Shanghai Zj Bio-Tech Co.Ltd(688317) board of directors January 19, 2022
