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BioNTech, Fosun Pharma Begin Clinical Trial Of MRNA-based COVID-19 Vaccine Candidate In China

BioNTech SE (BNTX) and Shanghai Fosun Pharmaceutical (Group) Co., Ltd announced Wednesday that the first 72 participants have already been dosed with BNT162b1 following IND approval by the Chinese regulatory authority, National Medical Products Administration (NMPA).

The Phase 1 trial will evaluate safety and immunogenicity in Chinese participants to support potential regulatory approval pathway 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.

BioNTech and Fosun Pharma are jointly developing the COVID-19 vaccine candidate in China. The trial is part of BioNTech's global development program aimed at supporting a global supply upon regulatory approval.

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.

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