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 respiratory syncytial virus vaccines has been approved by the U.S. Food and Drug Administration (“FDA”) recently, which is the first approval from FDA for the Group’s products and marks a significant progress for the Group’s internationalization strategy.

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 respiratory syncytial virus vaccines were significantly higher than those of the internationally marketed mRNA respiratory syncytial virus control vaccines.

Respiratory syncytial virus, a common respiratory tract infection pathogen, is highly contagious and widely prevalent worldwide. Respiratory syncytial virus infection is an important cause of death in 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 respiratory syncytial virus previously are still at risk of being reinfected with respiratory syncytial virus. At present, there is no approved antiviral drug specifically for respiratory syncytial virus that is available for clinical use worldwide. Vaccination for active immune prophylaxis is an effective means to avoid severe respiratory syncytial virus infection.

The Group is one of the enterprises that take the lead in developing mRNA vaccine products in China, and also one of the first batch of domestic vaccine enterprises that have obtained an independent patent for mRNA technology. The Group has a mature mRNA vaccine research and development system. Meanwhile, 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 the completion of the clinical trials as well as the acceleration of the commercialization process of vaccine products. As a new and globally heavyweight key vaccine product, this product is expected to become a new growth driver of the Group after its launch.