Shanghai Securities News, www.cnstock.com Recently, Amy Vaccine announced that the company had submitted a pre-application for clinical trials of respiratory syncytial virus (RSV) mRNA vaccine and shingles mRNA vaccine to the Center for Drug Evaluation, NMPA. Amy Vaccine stated that this is a new innovative progress the company has achieved after the development of rabies mRNA vaccine.

Previously, Moderna's mRNA respiratory syncytial virus (RSV) vaccine was approved for market launching in the United States, becoming the world's second commercialized mRNA vaccine.

As one of the earliest enterprises to develop mRNA vaccine products in China, and one of the first domestic vaccine enterprises to obtain independent patents for mRNA technology, Amy Vaccine is closely following market demands and accelerating the broader application of mRNA vaccines.

According to Amy Vaccine's announcement, RSV is a common respiratory tract infection pathogen, and RSV infection is an important factor leading to death in infants under one year of age and causing respiratory tract infection deaths in the elderly. Currently, there is no approved antiviral specific drug for RSV that can be used clinically worldwide, and vaccination is an effective means to avoid severe RSV infection. According to industry consultant China Insights Consultancy (CIC)’s forecast, it is expected that by 2030, the global market size of RSV vaccines will reach about $16.7 billion.

At the same time, Amy Vaccine introduced that the particularity of the varicella-zoster virus lies in its lifelong latency after the initial infection, and T cells mediate absolute immune protection. The shingles vaccine mainly reduces the risk of disease by increasing the level of specific T cell-mediated immune responses, preventing virus reactivation, and controlling intracellular viral infections. The advantage of mRNA vaccines is that they can effectively induce T cell responses without the need for adjuvants and without the safety risks associated with adjuvants.

At present, the vaccination rate of shingles vaccines in the target population is only about 0.1%, and there are no shingles mRNA vaccines approved for market launching in China. China Insights Consultancy (CIC) forecasts that by 2030, the market size of shingles vaccines in China will reach about 20 billion yuan, and the global market size will reach about $23.9 billion.

Since 2024, several domestic pharmaceutical companies, including Amy Vaccine, have successively announced the progress of non-COVID mRNA vaccine R&D, basically moving from pre-clinical research to clinical trial stages. According to Amy Vaccine's announcement, the company has now opened up the entire lifecycle process of mRNA vaccine R&D and production. After obtaining clinical permission, it can quickly achieve the industrialization of mRNA vaccine products and accelerate the commercialization process.

Amy Vaccine is full of confidence in accelerating the development of the domestic mRNA vaccine industry. "The company will further continue to focus on the key technologies of the mRNA platform and rapidly promote the R&D and registration of new products on this basis, focusing on unmet clinical needs in core disease areas, and further enhancing the company's innovation capabilities, core competitiveness, and comprehensive strength." Amy Vaccine stated.