APPLICATION FOR CLINICAL TRIAL OF THE MRNA SHINGLES/HERPES ZOSTER VACCINES T-CELL IMMUNITY, IgG ANTIBODY TITERS AND FLUORESCENT ANTIBODY TO MEMBRANE ANTIGEN TITERS WERE SIGNIFICANTLY HIGHER THAN THOSE OF COMMERCIALLY AVAILABLE RECOMBINANT SUBUNIT VACCINES
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 the
mRNA shingles/ herpes zoster vaccines developed by the Group has been submitted
to the Center for Drug Evaluation (CDE) of National Medical Products
Administration of China recently.
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 commercially available recombinant subunit control vaccines.
Shingles/herpes zoster virus is unique in
that it remains latent for life after the initial infection and T-cells mediate
absolute immune protection. It reduces the risk of developing shingles/ herpes
zoster by increasing specific T-cell immunity to prevent the virus from
reactivating and controlling intracellular infection. This corresponds to the
advantages of the mRNA vaccine, which is effective in inducing T-cell responses
without the addition of adjuvants and has no safety risks associated with adjuvants.
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 2023, the global sales of GSK shingles/herpes zoster vaccine reached
approximately US$4.286 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 Group has established a sound quality
management system for mRNA vaccines and a commercial-scale production workshop
in line with GMP standards, and the mRNA technology platform have been verified
by tens of thousands of human clinical trials data of mRNA vaccine products.
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 and commercialization of mRNA vaccine products after obtaining
clinical approval.