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SINOVAC Begins Clinical Trial for Reassortant Hexavalent Rotavirus Vaccine
Beijing, China – March 27, 2024 – Sinovac Biotech Ltd. ("SINOVAC" or the "Company") (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, announced that the Company has initiated Phase Ⅰ clinical trial of its Reassortant Rotavirus Vaccine, Live, Oral, Hexavalent (Vero Cell), and 20 people have finished enrollment on the first day.
This vaccine has been approved for clinical trial in January 2024. The study has two parts: an open-label, single-arm group involving adults and children; and a randomized, double-blinded, placebo-controlled group of infants, to evaluate the safety and tolerance in participants, and immunogenicity in infants of this vaccine.
The vaccine covers six rotavirus serotypes, G1, G2, G3, G4, G9, and P1A[8], and is one of the rotavirus vaccines with broad-spectrum protection 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 worldwide(1,2).
Globally, 41 G genotypes and 57 P genotypes of rotavirus have been identified(2), of which six G types (G1, G2, G3, G4, G9, and G12) and three P types (P[4], P[6], P[8]) are dominant(3). 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 2018(4,5).
SINOVAC is committed to providing high-quality vaccine products to mankind through scientific innovation and continues to expand its product pipeline. It currently includes bivalent enterovirus inactivated vaccine, adsorbed tetanus vaccine, hexavalent reassortment rotavirus vaccine, and more. With several products already approved for clinical research and others progressing to advanced stages of development, SINOVAC is dedicated to addressing pressing health needs and enhancing global immunization efforts.
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 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.