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- Fosun Diagnostics Receives China NMPA Approval for Its Independently Developed Novel Coronavirus Antigen Detection Kit amidst of the National Efforts in Pandemic Prevention and Control
Fosun Diagnostics Receives China NMPA Approval for Its Independently Developed Novel Coronavirus Antigen Detection Kit amidst of the National Efforts in Pandemic Prevention and Control
(13 April 2022, Shanghai, China) 13 April 2022, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma” or “the Group”; Stock Code: 600196.SH, 02196.HK) announced that the Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Colloidal Gold) self-developed by Fosun Diagnostics Co., Ltd. (“‘Fosun Diagnostics”), a subsidiary company of Fosun Pharma has received approval from the China's National Medical Products Administration (NMPA) for the commercial and clinical use of rapid antigen testing in COVID-19 screening.
Fosun Diagnostics’ Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Colloidal Gold) adopted the in- vitro qualitative detection method of Novel Coronavirus (2019-nCoV) Nucleocapsid antigen in nasopharyngeal swab samples from patients with respiratory and fever-related symptoms within 7 days, quarantine observers, and other antigen detection needs. Fosun Diagnostics’ Novel Coronavirus Antigen Detection Kit is equipped with high sensitivity and specificity, strong anti-interference ability and no cross-reactivity among viruses and bacteria. The kit is easy to use and quick to operate and deliver results in 15 minutes. It has a variety of reagents to meet various testing needs at point of demand whenever required.
The product has obtained the EU CE certification, duly completed BfArM registration in Germany, and officially endorsed by the EU Health Security Committee Common List (EU common list).
Lately, the State Council's of China under the Joint Prevention & Control for novel coronavirus pneumonia has decided to include antigen detection as a key supplement to nucleic acid detection under the "New Coronavirus Antigen Detection Application Plan (Pilot Trial)". Fosun Diagnostics’ Novel Coronavirus Antigen Detection Kit will contribute and continue serving the needs of pandemic prevention and control upon its recent approval.
Adhering to Independent Innovation and Providing Comprehensive Solutions for Covid-19 Nucleic Acid Testing
Since the outbreak of COVID-19, Fosun Pharma as a global innovation-driven pharmaceutical and healthcare group has fully integrated its business and global resources with timely response actively undertaking our social responsibilities in combating COVID-19 pandemic control.
As one of the Group's key strategic development segments, Fosun Diagnostics independently developed the Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit with the NMPA’s approval for emergency use in March 2020 while obtained the Registration Certificate for Medical Device (in vitro diagnostic reagents). Our Covid-19 test kits have also acquired relevant qualifications and certifications in the United States, European Union, Australia and many other countries and regions.
Fosun Diagnostics provides a comprehensive solution of reagents, equipment and consumables for the Novel Coronavirus nucleic acid testing. With clinically-validated, we offer many enhanced advantages in terms of fast and secure, flexible throughput, high sensitivity and reliable results. Fosun Diagnostics’ Novel Coronavirus Detection Kit is capable to detect 3 targets (ORF1ab, N and E genes) simultaneously. And our primer probe sequence is independently developed and designed with a sensitivity of up to 300 copies/mL and hence, grossly improved the detection rate for infected people with low virus content or asymptomatic people.
About Fosun Pharma
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.
Fosun Pharma is patient-centered and clinical needs-oriented. The company enriches its innovative product pipeline through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma has formed technological platforms for innovative small molecule drugs, antibody drugs, and cell therapy with a focus on key disease areas including oncology and immunomodulation, metabolism and digestive system, and central nervous system. Fosun Pharma also vigorously explores cutting-edge technologies, such as RNA, oncolytic viruses, gene therapy and PROTAC, to enhance its innovation capabilities.
Guided by the 4IN strategy (Innovation, Internationalization, Integration, and Intelligentization), Fosun Pharma will uphold the development model of “innovation transformation, integrated operation, and steady growth", with the mission of creating shareholder values as well as promoting the global networks through strengthening its innovative R&D and in-licensing ability and enriching its product pipelines. Fosun Pharma will actively promote the digital and physical business layout in the pharmaceutical and healthcare industry and is committed to becoming a first-class enterprise in the global mainstream medical and health market.
For more information, please visit our official website: www.fosunpharma.com.
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