Profile: Sinovac Biotech Ltd (SVA.O)
5 Oct 2015
Sinovac Biotech Ltd. (Sinovac), incorporated on March 1, 1999, is a holding company. The Company is a biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases including hepatitis A, hepatitis B, seasonal influenza, Haemagglutinase5 Neuraminidase1 (H5N1) and H1N1 pandemic influenza and mumps, as well as animal rabies. The Company's pipeline consists of vaccine candidates in the clinical and pre-clinical development Phases in China. The Company is engaged in sales, marketing, manufacturing, and development of vaccines for infectious disease. The Company is developing products, including Healive, Bilive, Anflu, Panflu Whole Viron Pandemic Influenza Vaccine, Split Viron Pandemic Influenza Vaccine, Panflu.1, RabEnd, Mumps Vaccine, EV71 Vaccine, Pneumococcal Polysaccharide Vaccine, Pneumococcal Conjugate Vaccine, Rubella Vaccine, Varicella Vaccine, Sabin Inactivated Polio Vaccine, Hep B Vaccines, and Hep A&B Vaccine, among others.
The Company's product Healive is a purified inactivated Hepatitis A vaccine without any preservatives, developed in China. Healive received the new drug certificate from the China State and Food Drug Administration.
The Company's product Bilive is a combination vaccine formulated with purified inactivated hepatitis A virus antigen, and recombinant (yeast) hepatitis B surface antigen. Bilive is available in different doses for use in both adults and children. The 1.0 milliliter dose is for non-immune adults and adolescents 16 years of age and older. The 0.5 milliliter 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. Booster vaccinations are recommended five years after the initial immunization.
The Company's product Anflu vaccine is an inactivated split viron influenza vaccine formulated from three split inactivated viron solutions. Anflu is derived from the influenza virus, which is cultured in chicken embryo, followed by harvest, inactivation, purification and disruption. The Company sells Anflu in Mongolia, Mexico, Philippines, Tajikistan, and Bangladesh.
The Company's product Panflu is an inactivated H5N1 influenza (avian flu) vaccine that was approved by State Food and Drug Administration. The product was co-developed by Sinovac Biotech Co., Ltd and the Chinese Center for Disease Control. The virus strain utilized for Panflu is NIBRG-14(A/VietNam/1194/2003(H5N1)RG).
The Company's product Panflu.1 is the approved vaccine against the influenza A H1N1 virus. Panflu.1 is made through inoculating and culturing the virus strain in chicken embryos, followed by harvesting, inactivating, concentrating, purifying and splitting process. The main ingredient in this product is the haemagglutinin antigen of influenza A (H1N1) virus.
The Company was granted a production license for mumps vaccine. Mumps is a viral disease of the human species caused by mumps virus.
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. 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. The Company was granted the production license of split viron pandemic influenza vaccine that is to be used among the teenagers aged from 12 to 17.
Enterovirus 71 (EV71), causes hand, foot and mouth disease (HFMD), among children under ten years old. The Company's EV71 vaccine is under New Drug Approval (NDA) processing.
Pneumococcal polysaccharide vaccine
Pneumococcal polysaccharide vaccine (PPV) is a vaccine used to prevent streptococcus pneumoniae (pneumococcus) infections, such as pneumonia and septicemia among adults aged 65 or older, adults with serious long-term health problems, smokers, and children older than two years with serious long-term health problems. The Company obtained the approval to commence clinical trials.
The Company has completed the pre-clinical studies of a human vaccine against varicella. Varicella is a contagious infectious disease caused by the varicella-zoster virus (herpesvirus 3, Human). It affects children, is spread by direct contact or respiratory route via 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.
The Company competes with Kunming Institute of Biological Product, Sanofi Pasteur S.A., Merck Sharp & Dohme Corp, GlaxoSmithKline Biologicals, Changchun Institute of Biological Products, Pukang Biological Co., Ltd., Changchun Changsheng Life Sciences Ltd., Hualan Biological Engineering Inc., Aleph Biological Co., Ltd., and China National Biotec Group Co., Ltd.
Sinovac Biotech Ltd
No.39 Shangdi Xi Road, Haidian D
BEIJING BEJ 100085