Sinovac Biotech Ltd. announced that the China National Medical Products Administration (NMPA) has approved and issued a Product license for the Company’s 23-Valent Pneumococcal Polysaccharide (“PPV”) Vaccine to prevent the infection by streptococcus pneumonia in adults and children ages 2 years old and above.
Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, “The approval of our pneumococcal vaccine allows us to provide another high-quality product to address unmet medical needs for the Chinese population. This is our first bacterial vaccine product approved so far, broadening the potential of the company’s product portfolio.”
Sinovac started research and development of the 23-valent pneumococcal polysaccharide vaccine in 2009, completed pre-clinical studies in 2011 and was approved to conduct human clinical trials in May 2014. A phase III non-inferiority study conducted in 2015 demonstrated a good safety and immunogenicity profile and non-inferiority of immunogenicity of all 23 serotypes were observed, which was published in the Human Vaccines and Immunotherapeutics medical journal.