Kangtai Bio 13-valent pneumococcal polysaccharide conjugate vaccine is listed in Jiangsu

On January 24, the Jiangsu Provincial Vaccination Program and Pneumonia Immunization Prevention Strategy Conference was held in Nanjing. At the strategy meeting, the 13-valent pneumococcal polysaccharide conjugate vaccine independently developed by Minhai Biologics, a subsidiary of Kangtai Biologics, was officially listed in Jiangsu. On October 22, 2021, the vaccine has just obtained the certificate of batch issuance of biological products from the State Drug Administration, which also marks the official marketing of Minhai Bio's 13-valent pneumococcal polysaccharide conjugate vaccine.

Pneumococcal disease has always been one of the world's most important public health problems, with the World Health Organization estimating that between 700,000 and 1 million children under 5 years of age die each year worldwide from various pneumococcal diseases; in 2017, WHO listed pneumococcus as a "deadly drug-resistant bacterium that seriously threatens human health".

According to public information, the 13-valent pneumococcal polysaccharide conjugate vaccine independently developed by Minhai Bio is a double-carrier 13-valent pneumococcal polysaccharide conjugate vaccine, which uses two carrier proteins (tetanus toxoid/diphtheria toxoid) to bind to pneumococcal capsular polysaccharides, and has achieved good clinical results. The 13-valent pneumococcal polysaccharide conjugate vaccine is the world's best-selling blockbuster vaccine variety, with Pfizer generating approximately $5.85 billion in global sales in 2020. Minhai Biotech is the third enterprise in the world to obtain the drug registration certificate of 13-valent pneumococcal polysaccharide conjugate vaccine.

Pan Hongxing, director of the Vaccine Clinical Evaluation Institute of the Jiangsu Provincial Center for Disease Control and Prevention, said: "Vaccination with 13-valent pneumonia vaccine can protect children from the invasion of the 13 most common and harmful pathogenic serotypes of pneumococcus, help children establish protective barriers, and is of great significance to the healthy growth of children." ”

The advantage of using "dual carriers" in the 13-valent pneumonia vaccine independently developed by mainland China is that it can avoid the competition of a single carrier protein for helper T cells and have an inhibitory effect on the polysaccharide immune response. According to the phase III clinical trial data of the double-carrier 13-valent pneumonia vaccine produced by Minhai Biologics, a wholly-owned subsidiary of Kangtai Biologics, the positive rate of antibodies and the geometric average titer of antibodies against 13 serotypes of pneumococcal bacteria are not inferior to similar imported products. At the same time, in clinical trials, the incidence of adverse reactions was lower than that of the control group products. It is worth mentioning that the dual-carrier 13-valent pneumonia vaccine has a good effect on infants and children aged 6 weeks to 5 years old (before the 6th birthday), which greatly relaxes the time limit for vaccination compared with similar vaccines.

Kangtai Biology said that the domestic dual-carrier 13-valent pneumonia vaccine not only breaks through innovation in technology, but also has a price of only 458 yuan / dose in the case of the effectiveness and safety of the vaccine, which is more than 30% cheaper than imported vaccines. (Wu Wenfeng)