Profile: Sinovac Biotech Ltd (SVA.O)
27 Feb 2015
Sinovac Biotech Ltd. (Sinovac), incorporated on March 1, 1999, is a holding company. The Company is an integrated China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases, including hepatitis A, hepatitis A and B, seasonal influenza, H5N1 and H1N1 pandemic influenza and mumps, as well as animal rabies vaccine. The Company’s product pipeline also includes human vaccines against rotavirus, and human rabies that are in pre-clinical development. The Company specializes in the sales, marketing, manufacturing, and development of vaccines for infectious disease with unmet medical need. The Company’s pipeline consists of vaccine candidates in the clinical and pre-clinical development phases in China, including the EV71 vaccine and human vaccines for pneumococcal, rotavirus, rabies, varicella and rubella.
Healive is available in different doses for use by both adults (1.0 ml dose) and children (0.5 ml dose). The Company’s production line to manufacture its hepatitis vaccines, Healive and Bilive, interchangeably has an aggregate combined production capacity of approximately 10 million doses annually. The Company is selling Healive in Mongolia and Nepal, and is seeking the regulatory approval to sell Healive in Asia and South America.
Bilive is a combination vaccine formulated with purified inactivated hepatitis A virus antigen, which it manufactures, and recombinant (yeast) hepatitis B surface antigen, which it source from a third-party supplier. Bilive is designed for boost immunization or for users in the private-pay market who prefer the convenience of one inoculation rather than two. Bilive is available in different doses for use in both adults and children. The 1.0 ml dose is for non-immune adults and adolescents 16 years of age and older. The 0.5 ml dose is for pediatric use in non-immune infants, children and adolescents from one year up to and including 15 years of age. The standard Bilive vaccination schedule consists of three doses. The second dose is administered one month after the first dose and the third dose is administered six months after the first dose.
Anflu is produced with the virus strains recommended by the World Health Organization (WHO) each year. The Company’s production line to manufacture its flu vaccines, Anflu, Panflu and Panflu.1, interchangeably has an annual production capacity of approximately 8 million doses of Anflu.
Panflu is the vaccine available in China against the H5N1 influenza virus. The vaccine is approved for supply within China to the Chinese national vaccine stockpiling program. The Company’s production line to manufacture its flu vaccines, Anflu, Panflu and Panflu.1, interchangeably has an annual production capacity of approximately 20 million doses of Panflu or 20 million doses of Panflu.1 given the yield of virus strain received from WHO.
Split viron pandemic influenza vaccine
The Company’s split viron pandemic influenza vaccine has been developed in conjunction with its whole viron pandemic influenza vaccine. Split viron vaccines are considered to have a better safety profile than whole viron vaccines, both of which are for the governmental stockpiling program. This product has been developed to address the needs of young children, who may be more susceptible to adverse reactions to whole viron pandemic influenza vaccine than to a split viron vaccine.
Animal rabies is the cause of transmission that results in human rabies. Animal vaccination can reduce the incidence of rabies in humans by reducing human contact with rabid animals. The vaccine is manufactured in Tangshan Yian.
EV71 causes HFMD among children under ten years old. HFMD is a common and usually mild childhood disease; however, HFMD caused by EV71 has shown a higher incidence of neurologic involvement, and a higher acute fatal incidence.
Pneumococcal conjugate vaccine
Pneumococcal is a cause of serious illness in children and adults throughout the world. The disease is caused by a common bacterium, the pneumococcus, which can attack different parts of the human body. According to the WHO, pneumococcal disease is the vaccine-preventable killer of children under five years old in the world. The Company’s pneumococcal conjugate vaccine will primarily target children two years old or under, who numbered approximately 32 million in China.
Pneumococcal polysaccharides vaccine
Pneumococcal polysaccharide vaccine, or PPV, is a vaccine used to prevent Streptococcus pneumoniae (pneumococcus) infections such as pneumonia and septicemia. In the United States, PPV is recommended for adults 65 years of age or older, adults with serious long-term health problems, smokers, and children older than two years with serious long-term health problems.
Human rabies vaccine
Rabies is an infection of the central nervous system acquired through the bite of a rabid animal. The WHO recognizes rabies as the infectious disease with the highest fatality rate in humans, which is 100% when left untreated. Rabies is prevalent in China and the only preventative treatment against rabies in humans is vaccination. It is conducting pre-clinical study of a human rabies vaccine.
Varicella is a contagious infectious disease caused by the varicella-zoster virus (Herpesvirus 3, Human). It usually affects children, is spread by direct contact or respiratory route through droplet nuclei and is characterized by the appearance on the skin and mucous membranes of successive crops of lesions that are easily broken and become scabbed. It has completed the pre-clinical studies of a human vaccine against varicella.
The Company competes with Hualan Biological Engineering Inc., Changchun Institute of Biological Products, Changchun Changsheng Life Sciences Ltd, Sanofi Pasteur S.A., GSK, Shanghai Institute of Biological Products and Aleph Biological Co., Ltd.
Sinovac Biotech Ltd
No.39 Shangdi Xi Road, Haidian D
BEIJING BEJ 100085