(10 September, 2020, Shanghai) Recently, Shanghai Fosun Pharmaceutical (Group) Co., Ltd (“Fosun Pharma” or “Group”; Stock Symbol: 600196.SH, 02196.HK) announced that the Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit (“the Kit”) self-developed by its wholly-owned subsidiary, Shanghai Fosun Long March Medical Science Co., LTD (“Fosun Long March”) was officially included in the World Health Organization (WHO) Emergency Use Listing (EUL).
Previously, the Kit has received the medical device registration certificate issued by the China National Medical Products Administration (NMPA) and was granted CE certification from the European Union (EU), Emergency Use Authorization (EUA) from U.S. Food and Drug Administration (FDA) and certification from Therapeutic Goods Administration (TGA).
The Novel Coronavirus nucleic acid detection kit self-developed by Fosun Long March is one of the Novel Coronavirus detection products with reliable performance and high degree of automation on the market. This kit can realize qualitative detection of Novel Coronavirus RNA targeting for its specific ORF1ab, N and E gene, and can complete the detection of 96 samples within two hours by supporting fast automatic nucleic acid extraction instrument and extraction reagents. In addition, automated testing will lower the risk of operator infection, reduce the probability of cross contamination in the clinical laboratory, and improve detection efficiency.
On January 30, 2020, WHO announced the Novel Coronavirus outbreak as a public health emergency of international concern and initiated EUL, an in-vitro diagnostic reagent to test Coronavirus. Products approved by WHO for emergency approval will be included in EUL to provide references for diagnostic products procurement by WHO, agencies of the United Nations and other international, regional or national procurement agencies.