VOLUNTARY ANNOUNCEMENT PRE-APPLICATION FOR MARKETING REGISTRATION FOR 13-VALENT PNEUMONIA CONJUGATE VACCINE SUBMITTED
The board of directors of the Company (the “Board”) is pleased to announce that on 29 February 2024, the Group has submitted the pre-application for marketing registration for its 13-valent pneumonia conjugate vaccine, and plans to officially complete the application for marketing this year.
The 13-valent pneumonia conjugate vaccine is mainly used in infants and children aged 6 weeks to 5 years old to prevent invasive diseases caused by 13 pneumonia serotypes (including bacteremia pneumonia, meningitis, septicemia and bacteremia) included in the vaccine. Pneumonia disease is the main cause of illness and death in children under the age of 5. The World Health Organization (the “WHO”) listed children’s pneumonia diseases as diseases that require high priority use of vaccines for prevention, and recommended the use of 13-valent pneumonia conjugate vaccine for vaccination. In the WHO’s classification for vaccine-preventable diseases, pneumonia series products are at the “extremely high priority” level. Therefore, the 13-valent pneumonia conjugate vaccine has a huge market prospect and will be in short supply after its launch. The construction of the Group’s pneumonia series vaccine GMP workshop has been completed to meet international standards. The Phase III clinical samples of the 13-valent pneumonia conjugate vaccine are all produced in the standardized workshop.
The 13-valent pneumonia conjugate vaccine is mainly used in infants and children aged 6 weeks to 5 years old to prevent invasive diseases caused by 13 pneumonia serotypes (including bacteremia pneumonia, meningitis, septicemia and bacteremia) included in the vaccine. Pneumonia disease is the main cause of illness and death in children under the age of 5. The World Health Organization (the “WHO”) listed children’s pneumonia diseases as diseases that require high priority use of vaccines for prevention, and recommended the use of 13-valent pneumonia conjugate vaccine for vaccination. In the WHO’s classification for vaccine-preventable diseases, pneumonia series products are at the “extremely high priority” level. Therefore, the 13-valent pneumonia conjugate vaccine has a huge market prospect and will be in short supply after its launch. The construction of the Group’s pneumonia series vaccine GMP workshop has been completed to meet international standards. The Phase III clinical samples of the 13-valent pneumonia conjugate vaccine are all produced in the standardized workshop.