From a "cold edge" technology to large-scale commercial application, a new chapter of medicine belonging to mRNA therapy has opened. In the post-epidemic era, the mRNA technology platform, which has become famous due to COVID-19 vaccines, is showing more and more possibilities for drug development.

Following the approval of Moderna's respiratory syncytial virus (RSV) vaccine by the U.S. Food and Drug Administration, another vaccine company has made progress in mRNA vaccines for non-COVID diseases: Amy Vaccine (06660.HK) announced on the Hong Kong Stock Exchange on June 4 that the respiratory syncytial virus (RSV) mRNA vaccine and shingles mRNA vaccine have submitted clinical trial pre-applications.

In the WHO pre-qualification list for vaccines, the RSV vaccine is of high priority. According to Amy Vaccine's announcement, RSV infection is an important cause of death in infants under one year of age and a significant factor in respiratory tract infection deaths among the elderly. Additionally, people who have been infected with RSV are still at risk of reinfection. In the United States, about 60,000 to 160,000 elderly people are hospitalized due to RSV infection each year, and 6,000 to 10,000 die from it.

According to a research report by AVIC Securities, RSV infection accounts for 2.30% of all factors leading to neonatal death (0-27 days) and 6.70% of the causes of death in later infancy (28 days-1 year), ranking first in lower respiratory tract infections, exceeding the proportion of influenza and Haemophilus influenzae. According to "Comparison of the Epidemiological Characteristics of Respiratory Syncytial Virus Infection and Clinical Severity of Influenza Virus Infection in Hospitalized Elderly Patients with Respiratory Tract Infections in Guiyang from 2016 to 2020", the fatality rate of RSV infection in people over 60 years old is 5.8%, higher than that of the influenza virus.

Currently, there is no antiviral specific drug approved for clinical use against RSV worldwide, making prevention through vaccination a crucial strategy to counter its health threats. In other words, herd immunity can be achieved through vaccination, thereby reducing the incidence and fatality rates of RSV.

So far, no RSV vaccine has been approved for market launching in China. Previously, GSK and Pfizer's RSV vaccines had global sales of $2.46 billion in 2023. According to industry consultant China Insights Consultancy (CIC), it is predicted that by 2030, the global market size of RSV vaccines will reach about $16.7 billion.

Amy Vaccine's another clinical trial pre-application submitted for the shingles mRNA vaccine also has a broad prospect. Shingles is a disease caused by the reactivation of the varicella-zoster virus (VZV) and usually occurs in adults and the elderly. Data shows that about 95% of people over 50 worldwide have been infected with VZV and are at risk of developing shingles. The incidence and severity of this disease increase with age. Under these circumstances, the shingles vaccine has become another blockbuster adult vaccine variety after the HPV vaccine, and vaccination is urgent.

At present, the shingles vaccine is still in the early stages of commercialization in China. Guosen Securities estimates that the penetration rate of the eligible population in China is only 0.3%. Assuming that by 2032, the cumulative penetration rate of people over 50 years old in China reaches 15%, the domestic market size of shingles vaccines is expected to exceed 30 billion yuan at that time.

According to a research report by Minsheng Securities in October 2023, there are currently two shingles vaccines on the market in China, namely GlaxoSmithKline's recombinant shingles vaccine Shingrix and BCHT Biotechnology's live attenuated vaccine Ganwei. According to the clinical trial data, in terms of protection rate, Shingrix has a higher protection efficiency, while Ganwei has a relatively lower protection rate. However, in terms of adverse reaction incidence, the live attenuated shingles vaccine has an advantage.

The shingles vaccine developed through mRNA technology can provide better protection for the vaccinated population. According to Amy Vaccine's announcement, the shingles vaccine mainly reduces the risk of shingles by increasing the level of specific T cell-mediated immune responses, preventing virus reactivation, and controlling intracellular viral infections. This corresponds to the advantage of mRNA vaccines, which can effectively induce T cell responses without the need for adjuvants and without the safety risks associated with adjuvants.

mRNA vaccines have gained fame due to the COVID-19 pandemic and have made two 2023 Nobel laureates in Physiology or Medicine, Hungarian scientist Katalin Karikó and American scientist Drew Weissman.

Of course, the application potential of mRNA technology extends far beyond COVID-19 vaccines. In addition to the aforementioned RSV and herpes zoster virus, human rabies vaccines are also an applicable field for mRNA technology. Amy Vaccine has developed an mRNA iterative rabies vaccine based on the mRNA platform, which is also the first non-COVID mRNA vaccine accepted by the Center for Drug Evaluation, NMPA for clinical trial application. Extensive animal experiments have proven that compared with traditional rabies vaccines cultured through virus cultivation, this vaccine has significantly fewer immunization injections and significantly faster production of protective neutralizing antibodies, with enhanced overall protective effects.

It is reported that Amy Vaccine 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 of vaccine products. 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 has a mature mRNA vaccine R&D system and has developed several mRNA candidate vaccines (including but not limited to rabies mRNA vaccine, RSV mRNA vaccine, shingles mRNA vaccine, etc.). At the same time, it has established a comprehensive mRNA vaccine quality management system and a commercial-scale production workshop that meets GMP standards, with a strong mRNA technology platform and industrialization capabilities. In the field of infectious disease vaccines, therapeutic vaccines, and medical therapies, mRNA is showing more and more potential. With the increase of investment by giants, scientific progress and technological development, the world is also looking forward to the broader application of mRNA technology to benefit more patients.