Fosun Pharma Gains BioNJ Award for Self-developed COVID-19 RT-PCR Detection Kit

(Shanghai, China) During the BioNJ’s 29th Annual Dinner Meeting & Innovation Celebration earlier this month, Fosun Pharma was awarded the Heart of BioNJ with the COVID-19 RT-PCR Detection Kit which was independently developed by its subsidiary company Fosun Diagnostics. The organizer BioNJ said in the award review that the awards were presented to BioNJ members whose innovation, partnerships and dedication impacted the United States and the world in its battle against the pandemic. 

BioNJ is the life sciences trade association for New Jersey with nearly 400 member companies representing research-based life sciences organizations and stakeholders across the ecosystem from the largest biopharmaceutical companies to early-stage start-ups .Among the first group of manufacturers in China to develop novel coronavirus diagnostic reagents, Fosun Diagnostics independently developed the Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit with the National Medical Products Administration (NMPA)’s approval for emergency use in March 2020 while obtaining the Registration Certificate for Medical Device (in vitro diagnostic reagents). The Covid-19 RT-PCR Detection Kit is the first product in the industry to submit a complete clinical application data report. This product has also acquired relevant qualifications and certifications in the United States, European Union, Australia and many other countries and regions, and has been exported to more than 10 countries around the world.

Lately, the Joint Prevention and Control Mechanism of the State Council has decided to include antigen detection as a key supplementary diagnostic method to nucleic acid testing under the “New Coronavirus Antigen Detection Application Plan (Pilot Trial)”. On April 13th, 2022, with approval from the NMPA of the Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Colloidal Gold) self-developed by Fosun Diagnostics, Fosun Diagnostics has become one of the dual-certificate enterprises that have obtained the registration certificates of both Novel Coronavirus (2019-nCoV) Antigen Detection Kit and Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit. The Kit has obtained BfArM registration in Germany, endorsed by the EU Health Security Committee Common List (EU common list), and was awarded the CE certificate and it will be now made available across 27 EU countries as well as regions that recognize the CE marked.  Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group deep-rooted in China. Fosun Pharma directly operates businesses including pharmaceutical manufacturing, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business.
Since the outbreak of the COVID-19 pandemic in 2020, Fosun Pharma has made full use of its innovation capabilities and international experiences to actively participate in the global fight against the epidemic, with mobilization of supplies from around the world, development of COVID-19 drugs and research and development of novel coronavirus nucleic acid and antigen detection reagents. In collaboration with Germany’s BioNTech to jointly develop mRNA COVID-19 vaccine, Fosun Pharma continues to help fight the COVID-19 pandemic.