BioNTech and Fosun Pharma receive approval to commence COVID-19 Vaccine Candidate BNT162b2 trial in China

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AK&M 17 November 2020 11:47

BioNTech SE (“BioNTech”; Nasdaq: BNTX,) and Shanghai Fosun Pharmaceutical (Group) Co., Ltd (“Fosun Pharma”; Stock Code: 600196.SH, 02196.HK) on March 16, 2020 announced that the China National Medical Products Administration (hereinafter referred to as the "National Medical Products Administration") has approved the clinical trial in Mainland China for their mRNA vaccine candidate, BNT162b2, as it was informed in the press release BioNTech.

BioNTech through its partner Fosun Pharma will now commence a Phase 2 clinical trial in Mainland China. On March 13, 2020, BioNTech and Fosun Pharma announced their strategic collaboration to work jointly on the development and commercialization of potential COVID-19 vaccine products based on BioNTech’s mRNA technology platform in Mainland China, Hong Kong and Macau Special Administration Region and the Taiwan Region.

BNT162b2 is currently in Phase 3 clinical trials in the United States, Germany, Argentina, Brazil, South Africa, Turkey and other countries, and received Fast Track designation from the U.S. FDA (the U.S. Food and Drug Administration). In addition, a rolling submission to the European Medicines Agency (EMA) for BNT162b2 has been initiated.

Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. 

Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; stock code: 600196.SH, 02196.HK) is a leading healthcare group in China. Fosun Pharma has built a strong root in China and developed a global operation strategy, with pharmaceutical manufacturing and R&D being the largest and core business segment, together with strong presences in medical devices and diagnostics, healthcare services, pharmaceutical distribution and retail.

With R&D innovation as core driving factor, Fosun Pharma continues to optimize its pharmaceutical operations across both innovative and generic drugs. The company has established international R&D centers for excellence in areas such as innovative small molecule drugs, high-value generic drugs, biologics, and cell-therapy.

Under guidance of our 4IN strategy (Innovation, Internationalization, Integration and Intelligentization), Fosun Pharma follows the brand concept of Innovation for Good Health and strives to be a leading enterprise in the global pharmaceutical and healthcare markets.


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