On April 29, SWI(Shanghai) Biotechnology Co., Ltd. (hereinafter referred to as "SWI")independently developed COVID-19 mRNA vaccine was approved by the State Food and Drug Administration and will carry out clinical trials. This time, the iterative vaccine developed by Sri Lanka microorganism was approved for clinical trial. In the R&D and design of the vaccine, D614G mutation has been included in many COVID-19 variants such as Delta and Omikron, which has protective effect on current COVID-19 epidemic strains and has certain broad-spectrum.
SWI Microbial is one of the first innovative companies in China to conduct mRNA drug development and human clinical trials of mRNA tumor precision vaccines. The R&D and management team of SMC brings together a group of scientists who have returned from overseas and have worked in many world-renowned biopharmaceutical companies and have outstanding academic achievements.
SWI Microbial has mastered the core technology of mRNA vaccine and has the exclusive global interest in LPP nano delivery system; It has an independently developed platform for antigen analysis, prediction and sequence optimization; It has the core patent of the key technology/equipment for mass production of hundreds of millions of doses of mRNA vaccines annually, and the key materials have been completely replaced by domestic ones.
At present, SWI Microbial has established modern production plants in Zhoupu and Fengxian of Shanghai, which can realize large-scale quantitative production. It is estimated that the annual output of the two plants can reach 400 million doses.
In the future clinical trials, SWI Microbial will formulate a scientific and rigorous clinical trial plan, strengthen the quality control of clinical research samples, and timely report the phased progress of clinical research to the national drug review department. During the clinical trial, the company will further improve the process products, improve the process stability, and conduct systematic and complete production process validation.