NEWS
PRE-APPLICATIONS FOR CLINICAL TRIALS FOR TWO MRNA VACCINES OF RESPIRATORY SYNCYTIAL VIRUS (RSV) AND SHINGLES/HERPES ZOSTER OF AIM VACCINE SUBMITTED
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. In June 2024, the Group has submitted pre-applications for clinical trials for mRNA respiratory syncytial virus (RSV) vaccines and mRNA shingles/herpes zoster vaccines to the Center for Drug Evaluation of National Medical Products Administration.
1. About mRNA Respiratory Syncytial Virus (RSV) Vaccine
RSV, a common respiratory tract infection pathogen, is highly contagious and widely prevalent worldwide. RSV 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 RSV previously are still at risk of being reinfected with RSV. At present, there is no approved antiviral drug specifically for RSV that is available for clinical use worldwide. Therefore, the prevention of RSV has become an important strategy to resist the health threat from RSV, and vaccination for active immune prophylaxis is an effective means to avoid severe RSV infection. No RSV vaccine has been approved for marketing in China, and now there are two RSV vaccines from GlaxoSmithKline and Pfizer on the global market. In 2023, the global sales of RSV vaccines reached US$2.46 billion. According to the forecast of China Insights Industry Consultancy Limited, an industry consultant, it is expected that the global market size of RSV vaccines will reach approximately US$16.7 billion by 2030. Furthermore, Moderna also announced that its mRNA respiratory syncytial virus (RSV) vaccine (mRESVIA) had obtained approval for marketing from the FDA recently, which was the second commercialized mRNA vaccine in the world and further promoted the application of mRNA technologies in the research and development of non-COVID-19 vaccines. Also, RSV vaccine is expected to become a heavyweight product in the field of mRNA vaccines.
2. About mRNA Shingles/Herpes Zoster Vaccine
The distinctiveness of shingles/herpes zoster virus lies in its lifelong latency after primary infection and absolute immune protection mediated by T cells. The shingles/herpes zoster vaccines mainly reduce the risk of shingles/herpes zoster by increasing the level of specific T-cell-mediated immune response, preventing the reactivation of the virus and controlling the intracellular infection of the virus. This matches with the advantages of the mRNA vaccine, i.e., the ability to effectively induce T-cell responses without the addition of adjuvants and without the safety risks associated with adjuvants. Currently, the vaccination rate of shingles/ herpes zoster vaccines in the target population is only about 0.1%, and no mRNA shingles/ herpes zoster vaccines have been approved for marketing in China, leaving much room for improvement. According to the forecast of China Insights Industry Consultancy Limited, an industry consultant, it is expected that the market size of shingles/herpes zoster vaccines in China will reach approximately RMB20.0 billion and the global market size will reach approximately US$23.9 billion by 2030.
3. About the Group’s mRNA Technology Platform
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 and has developed several mRNA vaccine candidates (including but not limited to mRNA rabies vaccine, mRNA RSV vaccine and mRNA shingles/herpes zoster vaccine, etc.). Meantime, the Group has established a sound quality management system for mRNA vaccines and a commercial-scale production workshop in line with GMP standards, and vaccines produced on the Group’s mRNA technology platform have also been verified by clinical trials. 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 obtaining clinical approval and accelerating the commercialization process of vaccine products. In the future, the Group will continue to focus on the key technologies of the mRNA platform, and on this basis, rapidly advance the research and development and registration of new products. The Group will focus on addressing the unmet clinical needs in core disease areas and continue boosting the Company’s innovation capabilities, core competitiveness, and overall strength.
1. About mRNA Respiratory Syncytial Virus (RSV) Vaccine
RSV, a common respiratory tract infection pathogen, is highly contagious and widely prevalent worldwide. RSV 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 RSV previously are still at risk of being reinfected with RSV. At present, there is no approved antiviral drug specifically for RSV that is available for clinical use worldwide. Therefore, the prevention of RSV has become an important strategy to resist the health threat from RSV, and vaccination for active immune prophylaxis is an effective means to avoid severe RSV infection. No RSV vaccine has been approved for marketing in China, and now there are two RSV vaccines from GlaxoSmithKline and Pfizer on the global market. In 2023, the global sales of RSV vaccines reached US$2.46 billion. According to the forecast of China Insights Industry Consultancy Limited, an industry consultant, it is expected that the global market size of RSV vaccines will reach approximately US$16.7 billion by 2030. Furthermore, Moderna also announced that its mRNA respiratory syncytial virus (RSV) vaccine (mRESVIA) had obtained approval for marketing from the FDA recently, which was the second commercialized mRNA vaccine in the world and further promoted the application of mRNA technologies in the research and development of non-COVID-19 vaccines. Also, RSV vaccine is expected to become a heavyweight product in the field of mRNA vaccines.
2. About mRNA Shingles/Herpes Zoster Vaccine
The distinctiveness of shingles/herpes zoster virus lies in its lifelong latency after primary infection and absolute immune protection mediated by T cells. The shingles/herpes zoster vaccines mainly reduce the risk of shingles/herpes zoster by increasing the level of specific T-cell-mediated immune response, preventing the reactivation of the virus and controlling the intracellular infection of the virus. This matches with the advantages of the mRNA vaccine, i.e., the ability to effectively induce T-cell responses without the addition of adjuvants and without the safety risks associated with adjuvants. Currently, the vaccination rate of shingles/ herpes zoster vaccines in the target population is only about 0.1%, and no mRNA shingles/ herpes zoster vaccines have been approved for marketing in China, leaving much room for improvement. According to the forecast of China Insights Industry Consultancy Limited, an industry consultant, it is expected that the market size of shingles/herpes zoster vaccines in China will reach approximately RMB20.0 billion and the global market size will reach approximately US$23.9 billion by 2030.
3. About the Group’s mRNA Technology Platform
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 and has developed several mRNA vaccine candidates (including but not limited to mRNA rabies vaccine, mRNA RSV vaccine and mRNA shingles/herpes zoster vaccine, etc.). Meantime, the Group has established a sound quality management system for mRNA vaccines and a commercial-scale production workshop in line with GMP standards, and vaccines produced on the Group’s mRNA technology platform have also been verified by clinical trials. 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 obtaining clinical approval and accelerating the commercialization process of vaccine products. In the future, the Group will continue to focus on the key technologies of the mRNA platform, and on this basis, rapidly advance the research and development and registration of new products. The Group will focus on addressing the unmet clinical needs in core disease areas and continue boosting the Company’s innovation capabilities, core competitiveness, and overall strength.
