BioNTech and Fosun Pharma Announce Start of Clinical Trial of mRNA-based COVID-19 Vaccine Candidate in China
Phase 1 study will evaluate safety and immunogenicity in Chinese participants to support potential regulatory approval pathway in China
- Total of 144 participants to be enrolled in two age groups (18-55 and >55 years)
- Trial participants to receive either 10µg or 30µg of BNT162 or a placebo
- Clinical supply from BioNTech’s GMP-certified mRNA production facilities in Europe
MAINZ, Germany, and SHANGHAI, China, Aug. 05, 2020 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) and Shanghai Fosun Pharmaceutical (Group) Co., Ltd (“Fosun Pharma” or “Group”; Stock Symbol: 600196.SH, 02196.HK), today announced that the first 72 participants have already been dosed with BNT162b1 following IND approval by the Chinese regulatory authority, National Medical Products Administration (NMPA). 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 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. The first group of subjects immunized in Stage 1 of the study will be healthy adults aged 18 to 55 years, followed by elderly healthy participants (>55 years). As part of the two-dose cohort design, subjects will receive two injections (prime-boost), 21 days apart, of 10µg or 30µg of the vaccine candidate or placebo. The dose range selection was determined based on early data from clinical trials conducted in Germany and the United States. The participants will be dosed in Taizhou Clinical Phase1 Center, Jiangsu province.
The study is designed to support the regulatory approval process for the Chinese market and intends to confirm that the safety and immunogenicity profile observed in participants from the German and US trials is comparable to that of Chinese participants. The ongoing clinical studies conducted in Germany and the United States will continue to support studies in China.
“We are proud to be among the first international biopharmaceutical companies to initiate a clinical trial of a COVID-19 vaccine candidate in China as part of our effort to make our vaccine available globally, if approved. This is an important step toward our goal to reach marketing authorization and ensure vaccine supply in China to help prevent new COVID-19 outbreaks in the most populous country in the world,” said CEO and Co-founder of BioNTech, Ugur Sahin.