How long does it take for an innovative vaccine product to go from concept, R&D, to market launch? Most people might not imagine.

Statistics based on the experience of mature markets in Europe and America estimate that the answer is 8-12 years, and this is just the average level. Looking back, there are still many important vaccines that have taken 20 or even 30 years to complete this process: for example, the influenza vaccine took 14 years, and the hepatitis B vaccine took 38 years. The total cost of developing a new vaccine can reach 300 million to 1 billion US dollars.

The long R&D time and high investment make every step of vaccines, especially domestic vaccine single-item products, very precious.

On August 29, AIM Vaccine (06660.HK) disclosed the semi-annual report and the latest developments of several blockbuster single-item products.

Among them, aiming at the international market, AIM has submitted a pre-application for clinical trials of mRNA RSV (respiratory syncytial virus) vaccine and mRNA shingles vaccine to the U.S. Food and Drug Administration (FDA) for the first time in August 2024. Prior to this, these two mRNA vaccine products have shown good data compared to marketed control vaccines in animal tests, and a pre-application for clinical trials was submitted to the  Center for Drug Evaluation (CDE), NMPA in June 2024.

If the above two mRNA vaccines can pass the strict review and recognition of the FDA, they will not only obtain the endorsement of international authoritative institutions, providing stronger evidence for their safety and effectiveness, but also become a pass for accelerating clinical trials in multiple countries and regions around the world. Furthermore, this is expected to greatly promote the globalization process of AIM Group's products, responding rapidly to global public health needs.

It can be said that the above two mRNA vaccines from AIM are aiming at the vast blue ocean recognized by the industry - there is no mRNA shingles vaccine approved for marketing internationally, and there is no RSV vaccine approved for marketing in China.

Data shows that the vaccination rate of shingles vaccines in the target population is only about 0.1%, and it is still in the early stages of commercialization in China. According to industry consultant China Insights Consultancy (CIC)'s forecast, it is expected 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 US dollars.

Shingles vaccines based on mRNA technology can provide better protection for the vaccinated population. AIM Vaccine's announcement points out that shingles vaccines mainly reduce the risk of shingles by increasing the level of specific T cell-mediated immune responses, preventing virus reactivation, 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.

RSV is a common respiratory tract infection pathogen, not only an important cause of death in infants under one year of age but also a significant factor in respiratory tract infection deaths among the elderly, and people who have been infected with RSV are still at risk of reinfection with RSV. According to multiple research reports, the proportion of RSV infection deaths in neonates (0-27 days), later neonates (28 days-1 year), and the elderly over 60 years old is higher than that of the influenza virus.

However, there is currently no antiviral specific drug approved for clinical use against RSV worldwide, so vaccination for active immunization prevention has become an effective means to avoid severe RSV infection. There are currently RSV vaccines from GlaxoSmithKline and Pfizer on the market, with global sales of RSV vaccines reaching as high as 2.46 billion US dollars in 2023. 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 US dollars.

mRNA vaccines have gained fame due to the COVID-19 pandemic, but their technological application potential is far more than COVID-19 vaccines. Recently, Moderna's RSV vaccine was successfully approved, as the world's first non-COVID mRNA vaccine, which once again sparked external attention to mRNA technology.

This not only proves the potential of the mRNA technology platform to continue to launch more types of vaccines in the future, highlighting the wide value of the mRNA technology platform, but also proves the space for mRNA vaccine R&D enterprises to open a second growth curve.

AIM Vaccine is one of the earliest enterprises in China to develop mRNA vaccine products and is also one of the first domestic vaccine enterprises to obtain independent patents for mRNA technology, with a mature mRNA vaccine R&D system, having developed several mRNA candidate vaccines, in addition to the above two vaccines, it has also developed mRNA rabies vaccines and several other mRNA candidate vaccines.

It is reported that AIM 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.

More Pipeline Progress

As an innovator in the vaccine race, AIM Vaccine's progress does not stop there.

According to two announcements released by AIM on the same day, the company officially submitted clinical trial applications for the quadrivalent MDCK cell influenza virus vaccine and adsorbed tetanus vaccine to the Center for Drug Evaluation, NMPA in August 2024.

Currently, all influenza vaccines on the domestic market are produced based on chicken embryo technology, and there are no influenza vaccines based on cell substrates that have been approved for marketing. Organizations such as the World Health Organization and the U.S. Food and Drug Administration, as well as governments of many countries, encourage the use of animal cell culture technology to replace traditional chicken embryo technology for the production of influenza vaccines.

The influenza virus vaccine developed by AIM is cultivated using MDCK cells instead of chicken embryo, with a shorter production cycle, stable raw material supply, strong ability to cope with virus mutations, capable of automated and scaled-up cultivation in bioreactors, low contamination risk, easy for large-scale industrial production, and low virus mutation chances during passage, without ovalbumin, significantly reducing the risk of allergies. According to China Insights Consultancy (CIC)'s forecast, the market size of influenza vaccines in China is expected to be about 20 billion yuan by 2030.

Another vaccine product, the adsorbed tetanus vaccine, is an important step in achieving AIM's development of combined and multivalent products. This is a layout in line with industry development trends, which not only helps the company to consolidate its position in the domestic non-immunization program vaccine (Category II vaccine) field but also benefits the sustainable development of the company's vaccine business.

At the same time, AIM Vaccine is actively promoting the R&D of the adsorbed acellular pertussis-diphtheria-tetanus-Haemophilus influenzae type b (HIB) combination vaccine (quadrivalent vaccine), and is expected to submit clinical trial applications for the quadrivalent vaccine and its various component vaccines successively starting from 2024.

In the Era of New Quality Production Forces, AIM Writes the Narrative of Domestic Vaccine Innovation

In today's era of new quality production forces, all industries are striving to make solid progress in technological breakthroughs, production factor allocation and industrial upgrading, further highlighting the importance of technological innovation.

Vaccines are a long-cycle, high-investment industry and have now become one of the important positions of new quality production. The long-term development of the industry cannot be separated from the promotion of innovative products and blockbuster single-item products. It can be said that vaccines are one of the most effective "weapons" against disease transmission, and innovation is the "driving force" for the development of the entire vaccine industry.

Laying out more R&D pipelines and fully promoting the progress of mRNA vaccine pipelines both prove AIM's full pursuit of innovation.

According to the semi-annual report, AIM's product sales have covered all 31 provinces and autonomous regions in China, reaching more than 2,000 district and county disease control centers. The 8 commercialized products include recombinant hepatitis B vaccine (Hansen yeast), freeze-dried human rabies vaccine (Vero cell), inactivated hepatitis A vaccine (human diploid cell), mumps vaccine, double-valued hemorrhagic fever vaccine (Vero cell), and A, C, Y, and W135 group meningococcal polysaccharide vaccine (MPSV4); there are also 22 R&D vaccine products in the pipeline, covering the top ten global vaccine varieties.

As of June 30, 2024, AIM Vaccine has obtained 14 clinical permits and carried out 21 clinical trials. The production workshops for the 13-valent pneumococcal conjugate vaccine, serum-free iterative rabies vaccine, and 23-valent pneumococcal polysaccharide vaccine have been established, accelerating the marketing registration work.

The development of new technologies is not something that can be achieved overnight, and coupled with the strict regulation of vaccines by governments around the world, it requires vaccine companies to be well-prepared. The layout of the pipeline shows that AIM Vaccine has always been focusing on unmet clinical needs in key disease areas, in order to further enhance innovation capabilities, core competitiveness and comprehensive strength, creating higher investment value.

The integration of cutting-edge technology development, the increase in the supply of high-quality vaccines, the continuous strengthening of policy support, and the year-by-year improvement of people's health awareness are all driving the rapid development of China's and the global medical and pharmaceutical industry - innovation and technology, industry and market, health and society, will write the story of domestic vaccines.

It can be predicted that as an innovator in domestic vaccines, AIM Vaccine will leave a strong mark in this story.