LakeShore Biopharma Co. Ltd has announced the approval of a Phase III clinical trial by China's National Medical Products Administration (NMPA) for its YSJA rabies vaccine. The trial will investigate the immunogenicity and safety of a simplified four-dose regimen, potentially offering a more convenient and cost-effective vaccination schedule.
The Phase III trial, slated to commence in December 2024, is designed as a single-center, randomized, double-blind, controlled study. It will compare two distinct four-dose immunization schedules—the Zagreb regimen (two shots in the first session, followed by one shot in each of the next two sessions) and a modified Essen regimen (one shot across four sessions)—against the conventional five-dose Essen regimen. The primary endpoints are immunogenicity and safety.
Potential Benefits of Simplified Regimen
The adoption of a simplified four-dose regimen could offer several advantages. It may reduce the workload for healthcare professionals, minimize the number of hospital visits required, and improve patient adherence to the full vaccination course. Furthermore, it has the potential to alleviate the financial burden on patients, making rabies prevention more accessible.
Mr. Xu Wang, CEO of LakeShore Biopharma, stated, "The approval of this Phase III clinical trial for our YSJA rabies vaccine marks a significant milestone in our efforts to expand the regimen profile of our product... We believe that this trial will validate the clinical superiority of the YSJA rabies vaccine, and will help attract increased recognition and support from researchers, academics, and industry players around the world."
YSJA Rabies Vaccine: A Flagship Product
The YSJA rabies vaccine is considered LakeShore Biopharma's flagship product. According to Mr. Wang, it has already demonstrated its value in preventing rabies-related deaths and disabilities. The company aims to become a leading rabies vaccine supplier and increase its market share in China through this clinical trial and other ongoing efforts.
