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SINOVAC Announces Approval of Clinical Trial for Reassortant Hexavalent Rotavirus Vaccine
Beijing, China – January 11, 2024 – Sinovac Biotech Ltd. (“SINOVAC” or the “Company”) (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, announced that Reassortant Rotavirus Vaccine, Live, Oral, Hexavalent (Vero Cell) has been approved for clinical trial by the China National Medical Products Administration (NMPA).
The vaccine covers six rotavirus serotypes, G1, G2, G3, G4, G9, and P1A[8], and is one of the rotavirus vaccines with the broadest coverage of types that are currently marketed/under development in the world.
Human rotavirus (HRV) is the most common cause of severe fatal acute gastroenteritis in children under 5 years old and the most common cause of severe diarrheal disease in infants and young children worldwide1,2.
Globally, 41 G genotypes and 57 P genotypes of rotavirus have been identified2, of which six G types (G1, G2, G3, G4, G9, and G12) and three P types (P[4], P[6], P[8]) are dominant3. The monitoring data in China show that the main RV strain prevalent in China after 2012 is G9P [8], G3P[8], G1P[8], G2P[4], and G4P[8]. G9P[8] replaced G3P[8] as the dominant strain from 2012-2017 accounting for 78%, and G9P[8] accounted for 91.56% by 20184,5. However, this serotype of rotavirus is not covered by the currently available rotavirus vaccine.
Ms. Yaling Hu, General Manager of SINOVAC R&D, said, “I hope this vaccine will be launched as soon as possible to better protect children from rotavirus. SINOVAC has always dedicated in biological pharmaceutical innovation and tried to reach a large variety of product pipelines to achieve disease prevention and control by independent R&D and cooperation with other institutes.”
In the future, SINOVAC will continue to promote the R&D of multi-technology and multi-category products to provide premium quality products and services for disease control worldwide.
References
1.Yangtze River Delta Immunization Integration Working Group. and Chinese Medical Association Infectious Diseases Branch Children′s Infection and Hepatology Group. Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine] vol. 54,4 (2020): 392-405. doi:10.3760/cma.j.cn112150-20200102-00003.
2.Manouana, Gédéon Prince et al. “Molecular surveillance and genetic divergence of rotavirus A antigenic epitopes in Gabonese children with acute gastroenteritis.” EBioMedicine vol. 73 (2021): 103648. doi:10.1016/j.ebiom.2021.103648
3.Santos, Norma, and Yasutaka Hoshino. “Global distribution of rotavirus serotypes/genotypes and its implication for the development and implementation of an effective rotavirus vaccine.” Reviews in medical virology vol. 15,1 (2005): 29-56. doi:10.1002/rmv.448
4.Zhou, Xuan et al. “Surveillance of Human Rotaviruses in Wuhan, China (2019-2022): Whole-Genome Analysis of Emerging DS-1-like G8P[8] Rotavirus.” International journal of molecular sciences vol. 24,15 12189. 29 Jul. 2023, doi:10.3390/ijms241512189
5.Peng, Rui et al. “Reassortment and genomic analysis of a G9P[8]-E2 rotavirus isolated in China.” Virology journal vol. 20,1 135. 22 Jun. 2023, doi:10.1186/s12985-023-02064-5
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, and mumps.
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 was 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