On June 4th, the leading domestic mRNA vaccine company Emmy Vaccine (06660. HK) announced that the company had submitted clinical trial pre applications for two heavyweight single products, the Respiratory Syncytic Virus (RSV) mRNA vaccine and the Herpes Zoster mRNA vaccine, to the Drug Evaluation Center of the National Medical Products Administration in June. The announcement states that Aimee has now integrated the entire lifecycle of mRNA vaccine research and development, production, and other processes. After obtaining clinical licenses, it can quickly realize the industrialization of mRNA vaccine products and accelerate the commercialization process of vaccine products.
In recent days, the mRNA vaccine, which had outstanding performance in the global fight against the COVID-19 pandemic, has frequently spread heavy research and development achievements, allowing people to see more possibilities of this global cutting-edge technology besides the COVID-19 vaccine. On May 31, the US FDA approved the world's first mRNA vaccine outside the COVID-19, the respiratory syncytial virus (RSV) mRNA vaccine of Moderna. The industry evaluation indicates that the mRNA vaccine has entered a new stage and reached a new starting point.
According to the analysis of CITIC Securities Research Report, Modern's respiratory syncytial virus (RSV) mRNA vaccine (mRESVIA) was approved for marketing, becoming the second commercialized mRNA vaccine in the world, further promoting the application of mRNA technology in non COVID-19 vaccine research and development fields.
MRNA technology is by no means a flash in the pan. The Emmy vaccine, which was the earliest to establish an mRNA technology platform in China, has also demonstrated this through practical experience.
MRNA technology platform strength support accelerates running
Industry comments suggest that mRNA (messenger ribonucleic acid) is known as the third-generation vaccine technology. mRNA vaccines do not contain viruses themselves, but instead send "letters" to the immune system to produce proteins that fight against diseases. They have the advantages of fast production speed and high safety, and are expected to replace traditional vaccines in the future.
The respiratory syncytial virus (RSV) mRNA vaccine and herpes zoster mRNA vaccine that Aimei applied for clinical use this time, combined with two key elements of innovative technology and heavyweight single products, have aroused great market expectations.
According to the announcement, Emmy vaccine is one of the earliest enterprises in China to develop mRNA vaccine products, and also the first batch of vaccine enterprises in China to obtain independent patents for mRNA technology. It has a mature mRNA vaccine research and development system and has developed several mRNA candidate vaccines. On the mRNA platform, Aimei had previously received the first non COVID-19 mRNA vaccine in China, namely the mRNA iterative rabies vaccine, accepted by the State Food and Drug Administration.
In addition, the Emmy vaccine has a leading mRNA technology level in China. At present, Aime has established a comprehensive mRNA vaccine quality management system and a commercial scale production workshop that complies with GMP standards. The vaccines produced on the mRNA technology platform have also been validated through clinical trials.
Heavyweight single item mining gold in the blue ocean market
The two mRNA vaccines that Aimei announced for clinical application are both aimed at the widely recognized blue ocean in the industry.
Respiratory syncytial virus (RSV) is a common pathogen of respiratory infections and is highly contagious. RSV infection is a significant cause of death in infants under one year old, as well as a significant factor in respiratory tract infections in the elderly. People who have been infected with RSV still have the possibility of re infection.
More importantly, according to a research report by AVIC Securities, RSV infection accounts for 2.30% of all factors leading to neonatal (0-27 days) death, and 6.70% of the causes of infant death in the later stage of newborns (28 days to 1 year old). It ranks first among lower respiratory tract infection factors, surpassing the proportion of influenza and Haemophilus influenzae. According to the comparison of respiratory syncytial virus epidemic characteristics and clinical severity of influenza virus infection among hospitalized elderly respiratory infection patients in Guiyang City from 2016 to 2020, the mortality rate of RSV infection in elderly people over 60 years old is 5.8%, higher than that of influenza virus. The risk of death during hospitalization for elderly people is 5.38 times higher than that of uninfected elderly people.
At present, there are no approved antiviral drugs for clinical use against RSV worldwide. Therefore, vaccination for active immune prevention is an effective means to avoid severe RSV infection.
Industry consultant Zhuoshi Consulting data shows that it is expected that by 2030, the global market size of RSV vaccines will reach approximately 16.7 billion US dollars. Currently, there is no RSV vaccine approved for sale in China, and there are currently RSV vaccines from GlaxoSmithKline and Pfizer available for sale worldwide. In 2023, the global sales of RSV vaccines reached 2.46 billion US dollars.
The herpes zoster vaccine is a truly popular product. Herpes zoster, commonly known as "waist wrapped dragon", has a low immune function, especially among middle-aged and elderly people who are at high risk of developing the disease. The National Health Commission has issued the "Core Information on Elderly Disability Prevention", which clearly recommends that elderly people receive regular herpes zoster vaccines.
At present, there is no mRNA vaccine for herpes zoster in China, and the sales performance of other technology route products has confirmed the huge potential for commercialization. GlaxoSmithKline's herpes zoster vaccine has global sales exceeding 4 billion US dollars in 2023. On October 9th last year, Zhifei Biotechnology signed a contract with GlaxoSmithKline to represent its herpes zoster vaccine in China. On the day of the news disclosure, Zhifei Biotechnology's closing stock price rose 19.99%.
According to the Emmy vaccine announcement, the current vaccination rate of herpes zoster vaccine in the target population is only about 0.1%, and there is still huge room for improvement in the future. Zhuo Shi Consulting predicts that by 2030, the market size of herpes zoster vaccines in China will reach approximately RMB 20 billion, and the global market size will reach approximately USD 23.9 billion.
According to a research report by Minsheng Securities in October 2023, there are currently two herpes zoster vaccines on the market in China, namely the recombinant herpes zoster vaccine Shingrid from GlaxoSmithKline and the attenuated live vaccine Sensei from Baike Biotechnology. From clinical trial data, in terms of protection rate, Shingrix has a higher protection efficiency, while the protection rate of sensory organs is relatively low; But in terms of the incidence of adverse reactions, the attenuated live herpes zoster vaccine has advantages.
With the support of mRNA technology, the herpes zoster mRNA vaccine being developed by Aime highlights its advantages in upgrading and iteration. According to the Emmy vaccine announcement, the herpes zoster vaccine mainly reduces the risk of herpes zoster by increasing the level of specific T cell-mediated immune response, preventing virus reactivation, and controlling intracellular infection of the virus. This precisely corresponds to the advantage of mRNA vaccines, which can effectively induce T cell responses without the need for adjuvants, and there is no adjuvant related safety risk. In short, mRNA vaccines have better efficacy and safety.
Academician Gao Fu, then Director of the China Center for Disease Control and Prevention, once called for attention to mRNA vaccines at the 2021 National Conference on Vaccines and Health, as they provide unlimited thinking for humanity. The application of mRNA technology is undoubtedly a hot golden track in the field of biomedicine. According to incomplete statistics, at present, in addition to the Emmy vaccine, more than 10 enterprises in China, such as Dameon Biotech, Xinxin Biotech, Xingrui Pharmaceutical, and Jiachen Xihai, have deployed the mRNA vaccines other than COVID-19, including herpes zoster, RSV, and tumor vaccines. The deep accumulation of Emmy vaccine on the mRNA technology platform has laid a solid foundation for accelerating the launch of this technology route product.