According to the Zhitong Finance APP, AEM Vaccine (06660) announced that the group is actively advancing the development of the vaccine product pipeline in accordance with the established company strategy, leveraging the advantage of mRNA technology platform, rapidly advancing the research and development of mRNA vaccine series products through continuous technological innovation, and has submitted the pre-clinical trial application for mRNA RSV (respiratory syncytial virus) vaccine and mRNA herpes zoster vaccine to the U.S. Food and Drug Administration (FDA) for the first time in August 2024.

The above two mRNA vaccine products have submitted pre-clinical trial applications to the National Medical Products Administration Drug Evaluation Center (CDE) in June 2024.

The submission of the pre-clinical trial application to the U.S. FDA this time is based on the group's international strategy and the good data performance of the two mRNA vaccines compared to the commercially available control vaccines in animal experiments. This application not only highlights the strong power of the group's mRNA technology platform but also marks a solid step taken by the group in the global health field.

If these two mRNA vaccines pass the strict review and approval of the FDA, they will not only obtain endorsement from international authoritative institutions to provide stronger evidence for their safety and efficacy but will also become passes for them to accelerate clinical trials in multiple countries and regions globally. This measure can greatly promote the global process of the group's products and rapidly respond to global public health needs.

Currently, no mRNA herpes zoster vaccine has been approved for marketing internationally, and no RSV vaccine has been approved for marketing in China. The group has now established the entire life cycle process of mRNA vaccine research and production. After obtaining clinical approvals, it can quickly industrialize mRNA vaccine products, accelerate the commercialization process of vaccine products, and further achieve the mission of 'manufacturing conscientious vaccines, ensuring the health of all people.'

RSV is a common respiratory infection virus with high infectivity, widely prevalent globally, and a significant cause of infant mortality under one year old worldwide and also a significant factor in respiratory infection mortality in the elderly. People who have been infected with RSV still have the possibility of re-infection. Currently, there are no approved antiviral drugs for clinical use against RSV globally. Prevention against RSV has become an important strategy to combat its health threats, and active immunization through vaccination is an effective way to prevent severe RSV infections. China has not yet approved the marketing of RSV vaccines, while glaxosmithkline and pfizer globally market RSV vaccines. In 2023, global sales of RSV vaccines were $2.46 billion. According to industry consultant Zhuoshi Consulting forecasts, it is expected that by 2030, the global market size of RSV vaccines will reach around $16.7 billion. In addition, Moderna recently announced that the mRNA RSV vaccine (mRESVIA) has been approved by the FDA for marketing, becoming the second commercial mRNA vaccine globally, further driving the application of mRNA technology in non-COVID vaccine research and development, and RSV vaccines are expected to become a heavyweight product in the mRNA vaccine field.

The special nature of the herpes zoster virus lies in its lifelong latency after initial infection, and T cells mediate absolute immune protection. The herpes zoster vaccine mainly works by increasing the level of specific T cell-mediated immune response, preventing the virus from reactivation, and controlling the intracellular infection of the virus, thereby reducing the risk of herpes zoster. This corresponds to the advantages of mRNA vaccines, which can effectively induce T cell responses without the need for adjuvants, and without adjuvant-related safety risks. Currently, the vaccination rate of herpes zoster vaccine in the target population is only about 0.1%, and mRNA herpes zoster vaccines have not been approved for market in China, indicating huge room for improvement. According to industry consultants from Zhoushi Consulting, it is predicted that by 2030, the market size of herpes zoster vaccines in China will reach approximately 20 billion RMB, and the global market size will reach approximately 23.9 billion USD.

The group is one of the earliest companies in China to develop mRNA vaccine products, and is also one of the first domestic vaccine companies to obtain independent patents for mRNA technology. It has a mature mRNA vaccine R&D system and has developed several mRNA candidate vaccines (including but not limited to mRNA Rabies vaccine, mRNA RSV vaccine, mRNA herpes zoster vaccine, etc.). At the same time, the group has established a comprehensive mRNA vaccine quality management system and a commercial-scale production workshop that meets GMP standards. The vaccines produced on the group's mRNA technology platform have also undergone clinical trial validation. The group has now connected the entire life cycle of mRNA vaccine development and production, and can quickly achieve industrialization of mRNA vaccine products after obtaining clinical approval, accelerating the commercialization process of vaccine products. In the future, the group will continue to focus on key technologies of the mRNA platform, and quickly advance the development and registration of new products based on this. The group will focus on unmet clinical needs in core disease areas, further enhance the company's innovation capabilities, core competitiveness, and overall strength.