SINOVAC Quadrivalent Influenza Vaccine Authorized for Commercialization in the Dominican Republic

2022-11-29

November 29, 2022, Beijing -- Sinovac Biotech Ltd. ("SINOVAC" or the "Company") (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, announced that its quadrivalent influenza vaccine, QIV has recently been authorized for commercialization in the Dominican Republic, which marks the Company's first market approval for its QIV vaccine granted in Latin America.

Under cooperation with local partner Biotech Boma, SINOVAC received the Sanitary Registration Certificate issued by the Ministry of Public Health and Social Assistance of the Dominican Republic, to commercialize its QIV vaccine in the country.

Launched in 2020, QIV is the latest development of SINOVAC's influenza vaccine product family. Derived from the influenza virus recommended by the World Health Organization, the Company's QIV vaccine provides comprehensive protection and high immunogenicity and is approved for use in people aged 3 and above, especially children, the elderly and vulnerable as well as people in influenza epidemic areas. In the overseas market, the vaccine has been approved in Bangladesh for marketing use this year and the first batch of ready-to-fill bulk was shipped in September.

Each year in Latin America and the Caribbean, seasonal influenza is associated with an estimated 36,500 respiratory deaths and 400,000 hospitalizations¹.The seasonal rise of influenza in the Dominican Republic, located in the Caribbean region, occurs as early as October. Local public health authorities had issued an epidemiological alert against seasonal influenza and launched an annual influenza vaccination campaign in October, according to local English news source DOMINICANTODAY.COM.

In July, a phase III clinical trial for SINOVAC's quadrivalent influenza vaccine was initiated in the Republic of Chile through a collaboration with the Pontificia Universidad Católica de Chile (PI Dr. Pablo González). The study results will provide further evidence on the safety and immunogenicity of the Company's QIV vaccine, as well as a scientific basis for the use of the vaccine in Latin America and other countries and regions.

SINOVAC is pleased to help the Dominican Republic defend against infectious diseases. After the outbreak of COVID-19, SINOVAC's inactivated COVID-19 vaccine, CoronaVac^®, was approved for emergency use in the country in February 2021. To date, nearly 16 million doses of CoronaVac® have been shipped to the country.

SINOVAC also started the construction of its local vaccine manufacturing bases in Chile, in order to provide high-quality vaccines to the region, and strengthen local capabilities in infectious diseases prevention and control.

Reference:

1. Andrea S. Vicari, et al. "Seasonal Influenza Prevention and Control Progress in Latin America and the Caribbean in the Context of the Global Influenza Strategy and the COVID-19 Pandemic." Am J Trop Med Hyg. 2021 Jul; 105(1): 93–101. doi: 10.4269/ajtmh.21-0339.

About SINOVAC

Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of vaccines that protect against human infectious diseases.

SINOVAC's product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected Hand-Foot-Mouth disease (HFMD), hepatitis A, varicella, influenza, poliomyelitis, pneumococcal disease, mumps, etc.

The COVID-19 vaccine, CoronaVac^®, has been approved for use in more than 60 countries and regions worldwide. The hepatitis A vaccine, Healive^®, passed WHO prequalification requirements in 2017. The EV71 vaccine, Inlive^®, is an innovative vaccine commercialized in China in 2016. In 2022, SINOVAC's Sabin-strain inactivated polio vaccine (sIPV) and varicella vaccine were prequalified by the WHO.

SINOVAC was the first company to be granted approval for its H1N1 influenza vaccine Panflu.1^®, which has supplied the Chinese government's vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine, Panflu^®, to the Chinese government stockpiling program.

SINOVAC continually dedicates itself to new vaccine R&D, with more combination vaccine products in its pipeline, and constantly explores global market opportunities. SINOVAC plans to conduct more extensive and in-depth trade and cooperation with additional countries, and business and industry organizations.

For more information, please see the Company's website at www.sinovac.com.

Contact:

Sinovac Biotech Ltd.

PR Team

pr@sinovac.com

About SINOVAC

Sinovac Biotech Ltd. (SINOVAC) is a global biopharmaceutical company headquartered in China. Guided by its mission to “Supply Vaccines to Eliminate Human Diseases,” the Company is dedicated to the research, development, manufacturing and supply of vaccines and related biological products, providing vaccine products and related solutions for disease prevention and control worldwide.

SINOVAC has a diversified vaccine portfolio across multiple disease areas, including influenza, viral hepatitis, varicella, hand, foot and mouth disease (HFMD), poliomyelitis, rabies, tetanus, and pneumococcal disease. Three of SINOVAC's vaccines have been prequalified by the World Health Organization: the inactivated hepatitis A vaccine Healive®, the Sabin-strain inactivated poliomyelitis vaccine (sIPV), and the live attenuated varicella vaccine.

SINOVAC has extensive experience in vaccine research, development and commercialization for emerging infectious diseases and public health emergencies. The Company initiated vaccine R&D in response to major public health threats, including SARS, H5N1, H1N1, and COVID-19, and developed the world's first inactivated SARS vaccine (with Phase I clinical trials completed), China's first inactivated pandemic influenza vaccine against H5N1 (Panflu®), the world's first H1N1 influenza vaccine (Panflu.1®), and CoronaVac®, the world's most widely used inactivated COVID-19 vaccine. Beyond its marketed portfolio, SINOVAC continues to advance its R&D pipeline, spanning combination vaccines, recombinant protein vaccines, mRNA technologies, antibody-based products, and other next-generation technologies and product platforms, while expanding its capabilities in disease prevention and biopharmaceuticals.

With a long-standing commitment to innovation and global health, SINOVAC continues to deepen collaboration with research institutions, international organizations, and local partners while expanding its global presence. Through technological collaboration, localized production, and industrial partnerships, the Company aims to improve access to high-quality vaccines across regions, better address local disease prevention and healthcare needs, and strengthen preparedness for future public health challenges.

For more information, please see the Company's website at www.sinovac.com.