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SINOVAC's COVID-19 Vaccine Obtains the Official Pharmaceutical Product Registration in Hong Kong
December 20, 2022, Hong Kong -- Sinovac Biotech Ltd. ("SINOVAC" or the "Company") (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, announced that its COVID-19 vaccine, CoronaVac®, has been fully registered in Hong Kong under the Pharmacy and Poisons Ordinance Cap 138, on December 16, 2022. It is one of the first COVID-19 vaccines approved for such official registration in Hong Kong.
According to the latest approval from the Government of the Hong Kong Special Administrative Region (HKSAR) of the People's Republic of China, CoronaVac®, can be supplied to registered medical practitioners and institutions for both private and public markets. CoronaVac® can be used as a fully registered pharmaceutical product for children aged 3 and above.
On 2 Aug 2022, the Secretary for Health of HKSAR of China has approved the lowering of the minimum age for receiving CoronaVac® from 3 years to 6 months old for "off-label use", marking the only inactivated COVID-19 vaccine approved to use for children as young as 6 months old in the world.
To date, SINOVAC has delivered 9.46 million doses of CoronaVac® to Hong Kong and more than 8.7 million of doses have been administrated locally. With more than 2.9 billion doses shipped globally, CoronaVac® has been approved for use in more than 60 countries and regions worldwide, of which, more than a dozen country governmental health authorities in the Asia, Latin America, and Africa regions have approved vaccine use in children.
Last month, CoronaVac® was also validated by the World Health Organization ("WHO") for extended use in children as young as three years old under the Emergency Use Listing ("EUL") Procedure. This is the youngest age that the WHO has validated for EUL of COVID-19 vaccines in the world thus far.
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 under "Category 1 Preventative Biological Products" and 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 China-based global biopharmaceutical company, with a mission of "supply vaccines to eliminate human diseases", the company specializes in the research, development, manufacturing and commercialization of vaccines and related biological products that protect against human infectious diseases.
The company's diversified portfolio includes vaccines for influenza, viral hepatitis, varicella, Hand-Foot-Mouth disease (HFMD), poliomyelitis, pneumococcal disease, etc., of which 3 vaccines have been prequalified by WHO, including inactivated hepatitis A vaccine Healive®, Sabin-strain inactivated polio vaccine (sIPV), and varicella vaccine.
SINOVAC has a leading edge in developing vaccines to combat infectious disease outbreaks and was among the first to initiate R&D during major public health emergencies, including SARS, H5N1, H1N1, and COVID-19. The company developed the world's first inactivated SARS vaccine (Phase I completed), China's first H5N1 influenza vaccine (Panflu®), the world's first H1N1 influenza vaccine (Panflu.1®), and CoronaVac®, the most widely used inactivated COVID-19 vaccine globally.
Beyond its marketed portfolio, the company is advancing a robust pipeline that includes combination vaccines,recombinant protein vaccines and next-generation platforms such as mRNA technologies and antibodies.
With a long-standing commitment to innovation and global health, SINOVAC is expanding its global footprint by strengthening partnerships with research institutions, international organizations, and local partners. Through broader market presence, technological cooperation, and localized production, the company aims to accelerate vaccine development and supply, enhance regional access to high-quality products, and better address unmet medical needs while improving preparedness for future pandemics.
For more information, please see the Company’s website at www.sinovac.com.