Securities code: Zhejiang Orient Gene Biotech Co.Ltd(688298) securities abbreviation: Zhejiang Orient Gene Biotech Co.Ltd(688298) Announcement No.: 2022013 Zhejiang Orient Financial Holdings Group Co.Ltd(600120) gene biological products Co., Ltd
About New Coronavirus antigen self testing reagent obtained from Canada IO
Announcement of temporary authorization of designated supply
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.
Zhejiang Orient Financial Holdings Group Co.Ltd(600120) CLINITEST, New Coronavirus's self testing reagent, is a SIEMENS HEALTHINEERS of HEALGEN SCIENTIFIC LLC, a wholly owned subsidiary of Limited by Share Ltd biotechnology products (hereinafter referred to as "SIEMENS"). Recently, the company obtained the temporary use authorization of Health Canada interm order (hereinafter referred to as "Canadian IO") approved by the Ministry of health of Canada. The company is the designated authorized supplier of Siemens Medical self-test products for this antigen. After obtaining Canadian IO, this product can be sold in Canada and countries / regions that recognize Canadian IO during the emergency period of national emergency health events recognized by Canada. It is hereby announced as follows:
1、 Canadian IO temporary authorization
Product name certificate intended use authorization date licensee specifies authorization number supplier
CLINITEST RAPID COVID-19 is suitable for the direct detection of COVID-19 antigen in the direct nasal swab sample SIEMENS SIEMENS ANTIGEN SELF-TEST 343050. It is a 2022/4/1 HEALTHINEERS technology limited self testing reagent for non prescription self testing products. company
2、 Impact on the company
On the basis of obtaining EU CE certification, US FDA EUA access, China nmpa certification, Japan PMDA sales license, Saudi MDMA certification and corresponding market sales, the company added the designated supply of Canadian io for this covid-19 virus antigen self-test reagent, which is conducive to the company's further expansion of the international market and serving the global demand for covid-19 virus epidemic prevention. 3、 Risk tips
The future sales performance of this product in Canada mainly depends on the evolution and detection needs of the local covid-19 epidemic, the sales capacity and orders of Siemens Medical in Canada, and the validity period of IO authorization in Canada. Please pay attention to the investment risk in the secondary market.
It is hereby announced.
Board of directors of Zhejiang Orient Financial Holdings Group Co.Ltd(600120) gene biological products Co., Ltd
April 6, 2022
