Following the established corporate strategy, the Group proactively advances the development of the vaccine product pipelines, and leverages the advantages of the mRNA technology platform to accelerate the research and development of mRNA vaccine series products through on-going technological innovation. The application for clinical trial of mRNA RSV (respiratory syncytial virus) vaccines has been submitted to the U.S. Food and Drug Administration (“FDA”) recently.

In preclinical animal tests, results from a third-party testing unit showed that the specific IgG antibody titers, live-virus neutralizing antibody potency and specific T-cell immunity of the Group’s mRNA RSV vaccine were significantly higher than those of the internationally marketed mRNA RSV control vaccine.

RSV, a common respiratory tract infection pathogen, is highly contagious and widely prevalent worldwide. RSV infection is an important cause of death of infants under one year old and also an important factor in the death of respiratory tract infections in the elderly. Meanwhile, people who have been infected with RSV previously are still at risk of being reinfected with RSV. At present, there is no approved antiviral drug specifically for RSV that is available for clinical use worldwide, and vaccination for active immune prophylaxis is an effective means to avoid severe RSV infection. No RSV vaccine has been approved for marketing in China. In 2023, the global sales of RSV vaccines reached US$2.46 billion. According to the forecast of China Insights Industry Consultancy Limited, an industry consultant, it is expected that the global market size of RSV vaccines will reach approximately US$16.7 billion by 2030. This product, if progressing well, will accelerate the pace of internationalization of the Group and bring considerable performance growth to the Group.

The Group is one of the enterprises that takes the lead in developing mRNA vaccine products in China, and also one of the first batch of domestic vaccine enterprises that has obtained an independent patent for mRNA technology. The Group has a mature mRNA vaccine research and development system. Meantime, the Group has established a sound quality management system for mRNA vaccines and a commercial-scale production workshop in line with GMP standards, and the mRNA technology platform have been verified by tens of thousands of human clinical trials data of mRNA vaccine products. The Group has now smoothened the whole life cycle process such as the research, development and production of mRNA vaccines, allowing for rapid achievement of the industrialization of mRNA vaccine products after obtaining clinical approval and accelerating the commercialization process of vaccine products.