Shanghai Fosun Pharmaceutical Group [2196:HK] has received the acceptance notice for its phase I clinical trial application of a COVID-19 mRNA vaccine, BNT162b, from the National Medical Products Administration (NMPA) on July 13, as reported by Caixin on the following day. Fosun Pharma introduced the vaccine from Germany’s BioNTech [BNTX:US] and was authorized to develop and commercialize the product in Greater China, aiming to provide COVID-19 precautions for people who aged 18 or above.
On July 13, BioNTech and its partner Pfizer [PFE:US] received the Fast Track Designation from the US FDA for two of their most advanced mRNA-based vaccines, BNT162b1 and BNT162b2, accelerating their development and regulatory review processes. Currently, these two vaccines are in phase I/II clinical trials in both Germany and the US. Subject to regulatory's approval, BioNTech is expected to launch the vaccines’ phase IIb/III clinical trials as early as in late July with over 30,000 participants in various global sites. If these two vaccines succeed, the company is planning to produce over 100m and 1.2bn doses of these vaccines in total by the end of 2020 and 2021, respectively. Fosun Pharma said BioNTech will be responsible for the supply of the vaccine, and the Chinese firm has invested RMB14.06m of R&D expense in the vaccine, including the license fee. According to WHO’s data, 155 COVID-19 vaccines are under development in the globe with 23 under human clinical trials and four entering phase III clinical trials.