Fosun Diagnostics Receives Approval from China’s NMPA for its Novel Coronavirus Antigen Detection Kit Independently Developed as Part of National Pandemic Prevention and Control Efforts

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 samples of nasopharyngeal swab of 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 between viruses and bacteria. The kit is easy to use and quick to use and gives results in 15 minutes. It has a variety of reagents to meet various point-of-demand testing needs whenever needed.

The product has obtained EU CE certification, completed BfArM registration in Germanyand officially approved by the EU Health Security Committee Common List (EU Common List).

Recently, the Council of State of China as part of the joint prevention and control of novel coronavirus pneumonia has decided to include antigen detection as a key complement to nucleic acid detection under the “New Coronavirus Antigen Detection Implementation Plan coronavirus (pilot trial)”. Fosun Diagnostics’ new coronavirus antigen detection kit will contribute and continue to meet the needs of pandemic prevention and control upon its recent approval.

Adhere to independent innovation and provide comprehensive solutions for Covid-19 nucleic acid testing

Since the outbreak of COVID-19, Fosun Pharma, as an innovation-driven global pharmaceutical and healthcare group, has fully integrated its global operations and resources with rapid response by actively shouldering our social responsibilities in the fight against the COVID-19 pandemic.

As one of the key strategic development segments of the Group, Fosun Diagnostics has independently developed the Novel Coronavirus (2019-nCoV) RT-PCR detection kit with NMPA approval for emergency use in March 2020 while obtaining the registration certificate for medical device (in vitro diagnostic reagents). Our Covid-19 test kits have also acquired the relevant qualifications and certifications in United StatesEuropean Union, Australia and many other countries and regions.

Fosun Diagnostics provides a complete solution of novel coronavirus nucleic acid testing reagents, equipment and consumables. With clinical validation, we offer many improved benefits in terms of speed and safety, flexible throughput, high sensitivity and reliable results. Fosun Diagnostics Novel Coronavirus Detection Kit is able to simultaneously detect 3 targets (ORF1ab, N and E genes). And our primer probe sequence is independently developed and designed with sensitivity up to 300 copies/mL and hence has significantly improved the detection rate for low virus infected or people asymptomatic.

About Fosun Pharma

Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; stock code: 600196.SH, 02196.HK) is an innovation-driven global pharmaceutical and healthcare group with deep roots in China. Fosun Pharma directly operates businesses such as pharmaceutical manufacturing, medical devices, medical diagnostics and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas of distribution and retailing of pharmaceutical products.

Fosun Pharma is patient-centered and focused on clinical needs. The company enriches its pipeline of innovative products through diversified and multi-level cooperation models such as independent research and development, cooperative development, licensing and deep incubation. Fosun Pharma has formed technology platforms for innovative small molecule drugs, antibodies and cell therapy, focusing on key disease areas including oncology and immunomodulation, metabolism and digestive system, and the central nervous system. Fosun Pharma is also vigorously exploring advanced technologies, such as RNA, oncolytic viruses, gene therapy and PROTAC, to enhance its innovation capabilities.

Guided by the 4IN (Innovation, Internationalization, Integration and Intelligentization) strategy, Fosun Pharma will maintain the development model of “transformation of innovation, integrated operation and steady growth”, with the mission of creating shareholder values ​​as well as promoting the global networks by strengthening its innovative R&D and licensing capacity and enriching its product pipelines. Fosun Pharma will actively promote the digital and physical business setup in the pharmaceutical and healthcare industry and is committed to becoming a premier enterprise in the global medical and healthcare market.

For more information, please visit our official website: www.fosunpharma.com.

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SOURCE Fosun Pharma

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