Shanghai Fosun Pharma (SHA: 600196; HK; 02196) reported it has dosed the first 72 participants in a China Phase I trial of an mRNA vaccine for COVID-19. The initial phase of the trial enrolled healthy adults aged 18 to 55 years; the second phase will enroll 72 individuals who are over 55. In March, Fosun in-licensed Greater China rights to the vaccine from BioNTech (NSDQ: NVTX) of Germany in a $135 million deal. Pfizer (NYSE: PFE) partnered the ex-China rights to the candidate with BioNTech and plans to start a global Phase IIb/III trial soon.

The China trial is designed to confirm the results in China subjects of trials being conducted in Germany and the US.

In the randomized, placebo-controlled, blinded China Phase I trial, subjects 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 Taizhou Clinical Phase1 Center, located in Jiangsu province, is conducting the trial for Fosun.

The China trial is testing BioNTech's nucleoside-modified messenger RNA (modRNA) candidate BNT162b1. BioNTech has also developed BNT162b2, a similar candidate that was chosen for the global Phase IIb/III trial being conducted by BioNTech and Pfizer. According to the companies, BNT162b2 showed better tolerability and improved immune recognition of more spike T-cell epitopes.

Fosun and BioNTech said they are exploring the possibility of starting clinical trials of "other" BioNTech candidates in China.

Ai-Min Hui, President of Global R&D, and Chief Medical Officer 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.”

“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.

See our other articles on Fosun and BioNTech.

Disclosure: None.