Fosun Pharma Receives FDA Emergency Use Authorization (EUA) For Its COVID-19 RT-PCR Detection Kit
SHANGHAI, April 19, 2020 According to the website of the U.S. Food and Drug Administration ("FDA"), Shanghai Fosun Pharmaceutical (Group) Co., Ltd ("Fosun Pharma"; Stock Code: 600196.SH, 02196.HK) has received emergency use authorization (EUA) from FDA for its COVID-19 RT-PCR detection kit.
The testing kit which was self-developed by Fosun Long March, a wholly-owned subsidiary of Fosun Pharma, has received the medical device registration certificate issued by the China National Medical Products Administration (NMPA) and granted CE certification from the European Union ("EU"). 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.
Fosun Pharma has been engaged in the business of PCR hepatitis B virus diagnostic reagents since its establishment in 1994. Currently, its medical diagnosis product line is relatively comprehensive, covering biochemical diagnosis, immune diagnosis, molecular diagnosis and microbial diagnosis, POCT and mass spectrometry, and third-party detection service products, with a nationwide marketing network in China.
Fosun Pharma's business covering the entire healthcare industry chain, with pharmaceutical manufacturing and R&D segment as the core business, medical devices and diagnosis, healthcare services, as well as pharmaceutical distribution and retail. According to the company's FY2019 earnings results, the revenue of Fosun Pharma increased by 14.72% to RMB28,585million as compared to 2018. Among them, the medical devices and medical diagnosis segment achieved favorable growth and recorded operating income of RMB 3,736 million in 2019, an increase of 2.66% over 2018, 28.5% YoY increase on the same basis.
Here is the link to FDA Detail Doc https://www.fda.gov/media/137120/download