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