mRNA RSV vaccine applied for clinical trials in the United States

February 6, 2025  Source: drugdu 35

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Aimi Vaccine's mRNA vaccine series product research and development has made new progress. The company announced on February 5 that its independently developed mRNA RSV (respiratory syncytial virus) vaccine has recently applied for clinical trials to the U.S. Food and Drug Administration (FDA).

According to the announcement, in preclinical animal trials, the test results of third-party testing units showed that Aimi's mRNA RSV vaccine specific IgG antibody titer, true virus neutralizing antibody titer, and specific T cell immunity were significantly higher than the internationally listed mRNA RSV control vaccine.

As one of the main pathogens causing lower respiratory tract infections in infants and young children, the market demand for its vaccine is also huge. The global sales of RSV vaccines in 2023 were US$2.46 billion. According to the forecast of Zhushi Consulting, the global market size of RSV vaccines is expected to reach approximately US$16.7 billion by 2030. If the product progresses smoothly, it will accelerate the company's internationalization and bring considerable performance growth.

Aimi Vaccine is one of the earliest companies in China to develop mRNA vaccine products, with a mature mRNA vaccine research and development system. At the same time, it has established a complete mRNA vaccine quality management system and a commercial-scale production workshop that meets GMP standards. The mRNA technology platform has been verified by human clinical trial data of more than 10,000 mRNA vaccine products. Aimi has now opened up the entire life cycle of mRNA vaccine research and development, production, etc. After completing the clinical trials, it can quickly realize the industrialization of mRNA vaccine products and accelerate the commercialization of vaccine products.

Aimi Vaccine previously announced that the company is using AI to design the antigen structure and mRNA sequence of vaccines. The layout based on the mRNA technology platform includes but is not limited to mRNA RSV vaccine, mRNA shingles vaccine, mRNA iterative rabies vaccine, etc., and the research and development direction also considers expanding to non-communicable diseases such as tumor vaccines.

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