BioNTech SE and Shanghai Fosun Pharmaceutical announced that the China National Medical Products Administration has approved the clinical trial in Mainland China for their mRNA vaccine candidate, BNT162b2.
Wu Yifang, Chairman and CEO of Fosun Pharma, said: “As the ultimate weapon against the COVID-19 pandemic, vaccines will play a vital role in the economic development and social stability of the entire world. I would like to thank the National Medical Products Administration for their great support and for their approval of the clinical trial and we will continue our close collaboration with BioNTech. We are working together and moving forward with the clinical trials and commercialization of mRNA vaccines, to be able to also supply China.”
“This start of the b2 trial in China, in conjunction with the recent interim analysis of the global Phase 3 trial that indicates that our lead candidate may be effective in protecting against COVID-19, is another important step forward,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “Time is of the essence in this effort and we greatly appreciate the support by Chinese regulators and the collaboration with our Chinese partner Fosun Pharma. We will continue to collaborate closely to advance clinical development in China toward market approval.”
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. In addition, a rolling submission to the European Medicines Agency (EMA) for BNT162b2 has been initiated.