Sinovac Announces Product License for 23-Valent Pneumococcal Polysaccharide Vaccine

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, 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.

About Streptococcus Pneumonia

Streptococcus Pneumonia, a highly bacterial pathogen, contains more than 90 serotypes. The pathogen is directly spread mainly through respiratory droplets and can cause many diseases including Pneumonia, meningitis, bacteremia, and otitis media, among others. Streptococcus Pneumonia usually affects children and elderly people and results in hundreds of thousands of deaths worldwide each year.

About Sinovac

Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases. Sinovac’s product portfolio includes vaccines against enterovirus71 (EV71), hepatitis A and B, seasonal influenza, 23-Valent Pneumococcal Polysaccharide (“PPV”), H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella vaccine and mumps. Healive, the hepatitis A vaccine manufactured by the Company, has passed the assessment under WHO prequalification procedures in 2017. The EV71 vaccine, an innovative vaccine developed by Sinovac against hand foot and mouth disease caused by EV71, was commercialized in China in 2016. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, which it has supplied to the Chinese Government’s vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government stockpiling program. The Company is developing a number of new products including a Sabin-strain inactivated polio vaccine and combined vaccines. The COVID-19 vaccine, CoronaVac, developed by the Company is being tested in phase III trial in several countries outside of China. Sinovac primarily sells its vaccines in China, while also exploring growth opportunities in international markets. The Company is seeking market authorization of its products in over 30 countries outside of China.