On Jul. 14, 2020, Shanghai Fosun Pharmaceutical announced it had received the acceptance notice of clinical trial application for the licensed COVID-19 vaccine product candidate BNT162b1 The clinical trial application of the Vaccine was accepted by the National Medical Products Administration.

In March 2020, Fosun Pharma has obtained the license granted by German company BioNTech to exclusively develop and commercialize its vaccine products based on BioNTech’s proprietary mRNA technology platform targeting COVID-19 in China. The Vaccine candidate is a prophylactic biological product, aiming at the precaution of COVID-19 for people who aged 18 or above. According to public information, BioNTech has announced interim analysis data from an ongoing phase 1/2 study of mRNA-based vaccine candidate against SARS-CoV-2, and its two most advanced mRNA-based SARS-COV-2 vaccine candidates BNT162b1 and BNT162b2 have recently received the Fast Track Designation from the U.S. Food and Drug Administration (FDA). Subject to approval by regulatory authorities, BioNTech expects to begin a Phase 2b/3 trial as early as in later this month and expects up to 30,000 subjects to be enrolled in the trial.

mRNA is a nucleic acid molecule that carries genetic information. The mRNA vaccine introduces the genetic information into the human body, so that the cells in the body produce the corresponding antigen, which induces the body to produce neutralizing antibodies and stimulates the response of T cells, fighting against the virus through the dual mechanisms of humoral and cellular immunity. In the face of a outbreak, compared with traditional vaccines, mRNA vaccine possesses advantages such as more convenient synthetic and manufacturing process, strong immunogenicity with no need for additional adjuvant as needed by the traditional vaccine, and with a good safety.