Securities code: Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) securities abbreviation: Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) No.: pro 2022060
Bond Code: 143422 bond abbreviation: 18 Fuyao 01
Bond Code: 155067 bond abbreviation: 18 Fuyao 02
Bond Code: 175708 bond abbreviation: 21 Fuyao 01
Shanghai Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) (Group) Co., Ltd
New Coronavirus Ag detection kit for controlling subsidiaries
Notice of approval of registration
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 individual and joint liabilities for the authenticity, accuracy and completeness of its contents.
Special risk warning (the same as the text for short):
1. The approved New Coronavirus product (2019-nCoV) antigen detection kit (colloidal gold method) is only used for the auxiliary diagnosis of New Coronavirus (2019-nCoV) infection. When using this product, the applicable population should follow the relevant management requirements such as covid-19 virus antigen detection application scheme (Trial).
2. The actual sales of the approved products in the domestic market of China are affected by (including but not limited to) epidemic prevention and control demand, raw material supply, production and supply chain capacity, market competition environment, sales channels and many other factors, and there is uncertainty. The specific impact of this approved listing on the current and future operating performance of the group cannot be predicted.
1、 Overview
The New Coronavirus (2019-nCoV) antigen detection kit (colloidal gold method), which was independently developed by Shanghai Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) (Group) Limited by Share Ltd (hereinafter referred to as "the company"), was awarded by the State Administration for drug control (hereinafter referred to as "the State Administration of drug administration") in April 13, 2022. Medical device registration certificate of the people's Republic of China (in vitro diagnostic reagent) (hereinafter referred to as "this approved listing").
2、 Basic information of the product
Product Name: New Coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)
Registration Certificate No.: gxzz 20223400504
Name of registrant: Fosun diagnostics
Registration classification: Class III
Intended use: the product is used for the in vitro qualitative detection of New Coronavirus (2019-nCoV) nucleocapsid Nucleocapsid (N) antigen in nasal swabs. The applicable population shall refer to the application scheme for covid-19 virus antigen detection (Trial Implementation) and other relevant national regulations. The product can not be used alone for the diagnosis of New Coronavirus infection. The positive results only indicate that there may be a New Coronavirus specific antigen in the sample. The infection status should be judged by nucleic acid test results. Negative results can not exclude New Coronavirus infection, nor should it be used alone as a basis for treatment and disease management decisions. If the antigen test of suspected patients with corresponding clinical symptoms is positive or negative, further nucleic acid test should be carried out. The test positive subjects should report and isolate according to the local epidemic prevention and control policy, and seek corresponding medical help; The negative test subjects shall strictly comply with the local epidemic prevention and control requirements, and shall be confirmed by nucleic acid test if necessary. The product use environment shall comply with relevant national regulations such as covid-19 virus antigen detection application scheme (Trial).
Approval date: April 13, 2022
Expiry date: April 12, 2023
3、 Impact on Listed Companies
The product (the main one) has passed the EU CE certification, completed the German bfarm registration, and is listed in the EU health and Safety Commission HSC common list (EU general white list). The approved listing will be conducive to the market layout of the product in China (excluding Hong Kong, Macao and Taiwan, the same below) and serve the needs of covid-19 epidemic prevention and control. It is expected that the approved listing will have a positive impact on the performance of the group (i.e. the company and its holding subsidiaries / units, the same below), but the actual sales situation is also affected by (including but not limited to) epidemic prevention and control demand, raw material supply, production and supply chain capacity, market competition environment, sales channels and many other factors. Therefore, the specific impact of the approved listing on the current and future operating performance of the group cannot be predicted.
4、 Risk tips
1. This approved product is used for the in vitro qualitative detection of New Coronavirus (2019-nCoV) Nucleocapsid (N) antigen in nasal swab samples. It is suitable for patients with acute infection. The swab samples used for testing can be collected and tested by medical staff or tested personnel only for the auxiliary diagnosis of New Coronavirus (2019-nCoV) infection. When using this product, the applicable population should follow the relevant management requirements such as covid-19 virus antigen detection application scheme (Trial).
2, according to the official website of the State Administration of drug administration, including the diagnosis of Fuxing, as of April 13, 2022, there were 27 enterprises related New Coronavirus (2019-nCoV) antigen detection kit in China, which was approved for registration. In addition, the actual sales of the product is also affected by (including but not limited to) epidemic prevention and control demand, raw material supply, production and supply chain capacity and many other factors, which are uncertain.
China Securities News, Shanghai Securities News and securities times are the newspapers and periodicals designated by the company for information disclosure. The information published by the company is published in the above designated newspapers and periodicals and the website of Shanghai Stock Exchange（ http://www.sse.com.cn. ）The announcement published shall prevail. Please invest rationally and pay attention to risks.
It is hereby announced.
Board of directors of Shanghai Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) (Group) Co., Ltd. April 13, 2002
