MAINZ, Germany, and SHANGHAI, China, August 5, 2020  – 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 Phase 1, randomized, placebo-controlled, observer-blind 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 18-55 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 world,” said CEO and Co-founder of BioNTech, Ugur Sahin.

Ai-Min Hui, President of Global R&D, and CMO of Fosun Pharma said: ”Dosing the first Chinese subject with BNT162b1 marks a milestone of the global co-development program in China. We are closely working with BioNTech and regulatory authorities to evaluate the safety and efficacy of BNT162b1 and other mRNA vaccine candidates, in order to synchronize the development process in China with other countries, and to bring the vaccine to public as soon as possible, if the vaccine succeeds.”

Following on from the ongoing Phase 1/2 studies in Germany and the United States, the Chinese study will initially evaluate nucleoside-modified messenger RNA (modRNA) candidate BNT162b1, one of two vaccine candidates based on BioNTech’s proprietary mRNA technology to have received FDA Fast Track designation. Meanwhile, BNT162b2, the other of vaccine candidate is currently being evaluated in a global Phase 2b/3 trial conducted by BioNTech and Pfizer which commenced on July 27th. The companies also intend to explore the possiblity of initiating clinical development of other vaccine candidates based on BioNTech’s proprietary mRNA technology in China. 

During the clinical development stage, BioNTech will provide the clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe. If the vaccine receives marketing authorization in China, Fosun Pharma will exclusively commercialize the vaccine in Mainland China, Hong Kong and Macau Special Administration Region and Taiwan Region.