BioNTech and Fosun Pharma Announce the Start of a Phase 2 Clinical Trial of Lead mRNA COVID-19 Vaccine BNT162b2 in China November 25 jointly announced that their lead mRNA COVID-19 vaccine candidate BNT162b2 will be evaluated in a Phase 2 clinical trial in Taizhou and Lianshui, Jiangsu Province, China, as it was informed by BioNTech.
The Phase 2 clinical trial of BNT162b2 in China will be conducted by Jiangsu Provincial Center for Disease Control and Prevention (Public Health Research Institute of Jiangsu Province). The trial site is located in Taizhou China Medical City Vaccine Engineering Center and Lianshui County CDC, Jiangsu Taizhou People's Hospital, Lianshui County People's Hospital and other units. The online recruitment of volunteers will commence with the recruitment of 960 healthy participants, aged between 18 and 85, to assess the safety and immunogenicity of the vaccine candidate and to support future Biologic License Application (BLA) in China.
In the ongoing Phase 3 clinical study of the vaccine, BNT162b2 met all primary efficacy endpoints, with an efficacy rate of 95% in preventing symptomatic COVID-19 infection. Sufficient safety data was collected to support the submission of an Emergency Use Authorization (EUA) to the US Food and Drug Administration (FDA) on November 20, 2020. In addition, BNT162b2 is currently under regulatory review by regulatory authorities in Europe, the United Kingdom and Canada.
On March 13, 2020, Fosun Pharma became the strategic partner of BioNTech in China, jointly developing and commercializing vaccine products for COVID-19 based on its proprietary mRNA technology platform in Mainland China, Hong Kong and Macau Special Administration Region and the Taiwan Region. Since the collaboration between the two sides, Fosun Pharma has been deeply involved in the research and development of mRNA vaccines. In addition to comprehensively and deeply discussing the research and development plans with partners and completing clinical trials in China, Fosun Pharma has also designed and completed animal challenge trials of selected mRNA vaccines, including BNT162b2, in collaboration with Chinese research institutes, and shared outcomes with partners in a timely manner.
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. 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.
