China-based Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392) has announced the initiation and first subject enrollment in a Phase I clinical study for its 20-valent pneumonia vaccine. This marks a significant step in the development of a vaccine designed to provide broader protection against pneumonia.
Vaccine Development and Composition
The 20-valent pneumonia vaccine, co-developed by Jiangsu Kunli Biopharmaceutical Co., Ltd, is prepared with pneumococcal capsular polysaccharides from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F, covalently linked to recombinant pneumolysin. The vaccine consists of 20 kinds of polysaccharide-protein conjugates prepared in a specific proportion. Previous animal experiments have shown that the vaccine has good safety and immunogenicity, indicating its potential effectiveness in preventing pneumonia.
Regulatory Approval and Market Landscape
The product obtained clinical trial approval in China in September 2021, paving the way for this Phase I study. Currently, Pfizer’s Prevenar13, Walvax’s 13-valent pneumococcal conjugate vaccine, and Minhai Bio’s 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine have been approved for marketing in China. Additionally, the Lanzhou Institute of Biological Product, Sinovac Research & Development Co. Ltd, and CanSino Bio are developing their own pneumococcal conjugate vaccines, indicating a competitive yet growing market for pneumonia vaccines in China.-Fineline Info & Tech
