Group 1 - The company has received FDA approval for clinical trials of its mRNA shingles vaccine, marking a significant milestone in its international strategy [1] - The mRNA shingles vaccine demonstrates significantly higher specific T-cell immunity, specific IgG antibody titers, and membrane antigen fluorescent antibody (FAMA) titers compared to internationally marketed recombinant subunit vaccines [1] - The company is one of the earliest developers of mRNA vaccine products in China and has established a mature mRNA vaccine research and development system [3] Group 2 - The global incidence of shingles is increasing, with an annual incidence rate of 3‰ to 5‰ per person, and a projected market size for shingles vaccines in China reaching approximately 20 billion RMB by 2030 [2] - Currently, there are no approved mRNA shingles vaccines in the international market, and the vaccination rate among target populations is only about 0.1%, indicating significant growth potential [2] - The company has a comprehensive mRNA vaccine quality management system and a commercial-scale production facility that meets GMP standards, allowing for rapid industrialization of mRNA vaccine products after clinical completion [3]
艾美疫苗mRNA带状疱疹疫苗获美国FDA批准开展临床 其体液免疫、细胞免疫显著高于国际市售重组亚单位疫苗产品