Following its approval for clinical trials by the U.S. Food and Drug Administration (“FDA”) in March 2025, the mRNA herpes zoster vaccine developed by the Group has recently received the Drug Clinical Trial Approval Notice (《药物临床试验批准通知书》) from the National Medical Products Administration. The dual approval for the vaccine in both China and the U.S. fully demonstrates the strength of the Group’s mRNA technology platform. 

In preclinical testing, results from a third-party testing unit showed that the Group’s mRNA herpes zoster vaccine specific T-cell immunity, specific IgG antibody titers, and fluorescent antibody to membrane antigen (FAMA) titers were significantly higher than those of international commercially available recombinant subunit control vaccines. 

Herpes zoster is an infectious dermatosis caused by reactivation of the varicella-zoster virus (VZV), which has been latent in the body for a long time. The general population is universally susceptible to VZV, and serological evidence indicates that the infection rate of VZV among adults exceeds 90%. The incidence rate of herpes zoster is 3‰ to 5‰ person/ year, and 3‰ to 10‰ person/year in the Asia-Pacific region, with an annual increase of 2.5% to 5.0%. For people aged 50 or above, VZV-specific cellular immune function gradually decreases with age. As a result, the incidence, hospitalization rate and case fatality rate of herpes zoster gradually increase. The recurrence rate of herpes zoster is 1% to 10%, and its risk factors include advanced age, immunodeficiency and chronic diseases. Vaccination against herpes zoster is an effective measure to inhibit the onset of herpes zoster. The herpes zoster vaccine is vaccinated to prevent herpes zoster, postherpetic neuralgia (PHN) and other complications by inhibiting VZV reactivation. 

Currently, no mRNA herpes zoster vaccine has been approved for marketing in the world. The vaccination rate of herpes zoster vaccines among the target population in China is less than 1%, leaving much room for improvement. In 2024, the global sales of GSK herpes zoster vaccines reached approximately US$4.310 billion. According to the forecast of China Insights Industry Consultancy Limited, an industry consultant, it is expected that the market size of 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. Upon approval of the product for marketing, it will bring considerable growth to the Group’s performance. The mRNA herpes zoster vaccine of AIM is expected to reshape the market landscape due to its advantages in terms of safety and immunogenicity. 

The Group is one of the enterprises that takes the lead in developing mRNA vaccine products in China, and also one of the first batch of domestic vaccine enterprises that has obtained an independent patent for mRNA technology. The Group has a mature mRNA vaccine research and development system. The Group has now smoothened the entire industrialization 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, 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.