(RTTNews) – BioNTech SE (BNTX) and Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced Wednesday that the first participants had already won a dose of BNT162b1 following inD approval through China’s National Medical Products Administration (NMPA).
The Phase 1 trial will assess the protection and immunogenicity of Chinese participants for the possible path of regulatory approval in China.
The randomized, placebo-controlled, observer-blinded Phase 1 clinical trial in China will enroll 144 healthy subjects to evaluate the safety and immunogenicity of the vaccine as well as to confirm dose selection. Trial participants will receive either 10µg or 30µg of BNT162 or a placebo.
BioNTech will provide the clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe.
The ongoing clinical studies conducted in Germany and the United States will continue to support studies in China.
The companies also intend to explore the possibility of initiating clinical development of other vaccine candidates based on BioNTech’s proprietary mRNA technology in China.