Simplified Chinese
The world’s first 13-valent pneumococcal vaccine with a dual‑carrier system has been approved for market launch.
Release date:
2021-10-27
Author:
Source:
Abstract
Recently, the 13-valent pneumococcal polysaccharide conjugate vaccine independently developed by Beijing Minhai Biotechnology Co., Ltd. has received the batch release certificate for biological products from the National Medical Products Administration, marking the official approval of the vaccine for market launch and sale.
This vaccine is the world’s first bivalent‑carrier 13‑valent pneumococcal polysaccharide conjugate vaccine. It employs two carrier proteins (tetanus toxoid/diphtheria toxoid) conjugated to pneumococcal capsular polysaccharides, which, unlike single‑carrier pneumococcal polysaccharide conjugate vaccines, avoids the competitive inhibition of T‑helper cell responses that can occur when a single carrier protein competes for these cells. Phase III clinical trial data show: The vaccine demonstrated non-inferiority to comparable imported products in both the antibody positivity rate and the geometric mean titer against 13 serotypes of Streptococcus pneumoniae. Meanwhile, the data also indicate that the incidence of adverse reactions to this vaccine was lower than that observed in the control group and in comparable products.
According to estimates by the World Health Organization, pneumococcal infections claim 1.6 million lives worldwide each year, including 460,000 among infants and young children; accordingly, diseases caused by this pathogen have been designated as “extremely high-priority” for vaccine prevention. In April of this year, WHO’s “Immunization Agenda 2030” reiterated that widespread use of pneumococcal vaccines could reduce antibiotic‑prescribing days for children under five by 47%, potentially cutting global annual antibiotic‑use days by at least 11.4 million. Given its critical importance, the 13‑valent pneumococcal vaccine has become one of the best‑selling blockbuster vaccines globally.
Infants and young children are the primary reservoirs of pneumococcus, and vaccination remains the most cost-effective and efficient means of preventing infection. Kangtai Biological’s bivalent‑carrier 13‑valent pneumococcal vaccine has been approved for market launch, which is expected to further challenge the previous dominance of imported products, enhance the availability and affordability of this vaccine in China, and provide stronger protection for the health and well-being of infants and young children in the country.
Recommended Reading
Batch Release Status of the Company’s Products in 2026
2026-07-23
2026-07-15
2026-07-09
Contact Information
Customer Service Hotline
4001899806
Phone number
010-59613600
Official Website
Company Address
No. 35 Simiao Road and No. 25 Tianfu Street, Daxing Biomedical Industry Base, Zhongguancun Science Park, Daxing District, Beijing
WeChat Official Account