IMMUNE INDICATORS OF THE MRNA SHINGLES/HERPES ZOSTER VACCINES WERE SIGNIFICANTLY HIGHER THAN THOSE OF INTERNATIONAL COMMERCIALLY AVAILABLE RECOMBINANT SUBUNIT VACCINES APPLICATION FOR CLINICAL TRIAL OF THE PRODUCT IN THE U.S.
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. The application for clinical trial of mRNA
shingles/ herpes zoster vaccines has been submitted to the U.S. Food and Drug
Administration (“FDA”) recently, marking a new advancement in the Group’s
global strategy.
In preclinical animal testing, results from
a third-party testing unit showed that the Group’s mRNA shingles/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.
Currently, no mRNA shingles/herpes zoster
vaccine has been approved for marketing in the world. The vaccination rate of
shingles/herpes zoster vaccine in the target population is only about 0.1%,
leaving much room for improvement. In 2024, the global sales of GSK shingles/
herpes zoster vaccine 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 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. Upon approval of
the product for marketing, it will bring considerable growth to the Group’s
performance. The mRNA shingles/herpes zoster vaccine 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 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.