BioNTech SE and Shanghai Fosun Pharmaceutical 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.
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.
Ugur Sahin, M.D., CEO and Co-founder of BioNTech, said, “From the very beginning, our common goal has been to quickly design and develop a safe and effective vaccine for global supply. The clinical trial research carried out in China is an important part of the global research and development of BioNTech’s COVID-19 vaccine and marks an important step in bringing this vaccine to the people of China.”
Dr. Aimin Hui, President of Global Research and Development and Chief Medical Officer of Fosun Pharma, said, “The COVID-19 pandemic proves once again that global cooperation is needed to control infectious diseases. As an important part of global research and development, the Phase 2 clinical study with BNT162b2 in China will not only provide key data for the launch of the vaccine in China, but also may play a positive role in the widespread promotion and use of the vaccine throughout Asia and around the world.”
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.