COVID-19 Vaccine

Phase III was approved by Brazil authority on July 3, and has started on July 21, 2020.

Started in Indonesia on 11th Aug, 2020.

Also approved by Turkey and Bangladesh.

Efficacy result on rhesus model published in Science on May 6, 2020.

Phase I/II was commenced on April 16, and May 3, 2020.

Phase I/II trials were approved by NMPA on April 13, 2020.

Initial R&D of CIVID-19 vaccine on Jan 28,2020.


Virus Challenge test:
Institute of Laboratory Animal Sciences, Chinese Academy of Medical Sciences National Institution

Other safety tests:
JOINN Laboratories (Beijing)
CFDA GLP Certified
U.S.FDA GLP Inspected
AAALAC Accredited
OECD GLP Certified
Korean MFDS GLP Inspected
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Sinovac’s mission:
Supply Vaccines to Eliminate Human Diseases.
Provide Chinese Children with Top Quality Vaccine
Provide Children around the World with Vaccines Made in China.

To achieve these objectives, Sinovac focuses on research, development, manufacturing and
marketing of human-use and animal-use vaccines. The Company also provides services for
diseases control and prevention, collaborating with the Chinese governments at the national, state and local levels.

Sinovac’s history dates back to 1993 when its Chief Executive Officer Mr. Weidong Yin and
the team at Tangshan Yian Biological Engineering Co. Ltd. engaged in the initial R&D activities
that lead to the successful development of the Company’s hepatitis A vaccine in 1999, which is the first inactivated hepatitis A vaccine developed by Chinese scientists.

Over the past two decades, the Company has developed and commercialized six human-used vaccines and one animal vaccine, and advanced its R&D pipeline. The Company has achieved many significant development milestones that exemplify its core R&D competencies, inclusive of developing the first H1N1 vaccine in the world in 2009.

Moreover, it has expanded its fully integrated platform with state-of-the-art research facilities, GMP certified manufacturing facilities, and a sales team with reach across China. The Company is currently developing a novel vaccine against enterovirus 71, causing the severe hand, foot and mouth disease (HFMD) among the children. Sinovac has four locations across China that house its R&D and manufacturing facilities.

The Company is expanding its manufacturing capabilities to meet future demand for its pipeline vaccine products.

At its headquarters in Beijing, the Company has two production lines for the final bulk production of hepatitis vaccines and influenza vaccines. All of the existing two production lines are in compliance with China new GMP standard. The production line at its headquarters utilized to manufacture Healive and Bilive was designed by a European company using advanced equipment purchased from Europe and the United States. At the facility located in the Changping district of Beijing that was acquired in February 2010, A new filling and packaging line in compliance with China new GMP standards has been built up and been fully operational since May of 2013.

Sinovac has also built up a dedicated production line for the production of EV71 vaccine under development. Currently, the construction has been completed and waits for the GMP certification and site inspection from CFDA according to the new drug application process of EV71 vaccine. Sinovac Dalian has one China new GMP certified production line in operation for the production of mumps vaccine. At both Changping and Sinovac Dalian, additional space is available for expansion to add more production lines as its pipeline products reach commercialization. At the Tangshan Yian location, Sinovac operates a R&D facility and is manufacturing its animal rabies vaccine.

Sinovac has commercialized five vaccine products in China including Healive (Hepattis A），
Blve¬(Combined Hepattis A and B)， Anflu¬ (Seasonal Influenza）， Panflu TM (Pandemic nfuenza(H5N1), and PANFLU.1 TM (Pandemic nfuenza A (H1N1).


Sinovac’s R & D strategy focuses on:

In-house development:
To develop novel vaccines to prevent and control newly emerged infectious diseases such as SARS, avian influenza (H5N1), H1N1 influenza, and hand foot and mouth disease.

To develop new generation of conventional vaccines with technological innovation such as
hepatitis vaccines, seasonal influenza vaccine, mumps vaccine, varicella, etc., Sinovac has a well organized and experienced R&D team, which utilizes the innovative methods and technology, combined with government support to develop and market the top-quality vaccines to prevent and control infectious diseases.

Sinovac has successfully developed SARS vaccine and completed phase I clinical trial, which was the first company globally completing the phase I clinical trial. Additionally, Sinovac also succeeded in the research and development of human-used avian flu vaccine against H5N1 influenza, which was licensed in 2008, and is the only licensed H5N1 vaccine for China government stockpile. Due to the severe epidemic situation of hand foot and mouth disease (HFMD) in China and surrounding countries, Sinovac stood out again to develop a EV71 vaccine against HFMD caused by enterovirus 71. Currently, the phase III clinical trials have been completed and it is anticipated to be licensed in 2014.

In addition to develop the novel vaccines to against newly emerged diseases Sinovac also
utilizes the advanced technologies to develop the generic vaccines, such as hepatitis vaccines, seasonal influenza vaccine and mumps vaccine. In 2002, Sinovac launched the first proprietary
inactivated hepatitis A vaccine in China, providing the superior and much safer hepatitis A
vaccine to Chinese population compared to the other version. And in 2006, Sinovac launched
Anflu, the seasonal influenza vaccine which is the only preservative free influenza vaccine
supplied by domestic manufacturers. Now we are working on the research and development in
other generic vaccines to address the demand in both China and overseas market.

To establish collaborations in R&D with domestic and international partners on
technology and virus strains use rights licensing. We have collaborated with a group of leading universities, colleges and research institutes that have strong vaccine research capabilities and proven track records in China and overseas, such as University of Sydney, China CDC, National Institutes of Health, etc..

We will continue to keep open minded to find more opportunities to achieve our target