LakeShore Biopharma Co., Ltd has received approval from the National Medical Products Administration (NMPA) in China to begin a Phase III clinical trial evaluating simplified four-dose regimens of its YSJA rabies vaccine. The trial aims to demonstrate comparable immunogenicity and safety to the existing five-dose Essen regimen, potentially improving patient adherence and reducing healthcare burden.
The study, anticipated to commence in December 2024, is designed as a single-center, randomized, double-blind, controlled trial. It will compare two four-dose immunization schedules—the Zagreb regimen (2-1-1) and the Modified Essen regimen (1-1-1-1)—against the conventional Essen regimen (1-1-1-1-1). The primary endpoints will focus on assessing the immunogenicity and safety profiles of the simplified regimens.
Rationale for Simplified Regimens
The current standard of care for rabies post-exposure prophylaxis involves a five-dose Essen regimen. LakeShore Biopharma's initiative to explore simplified schedules addresses the need for greater flexibility in vaccine administration, potentially reducing the number of hospital visits and improving patient compliance. According to Mr. Xu Wang, Chief Executive Officer of LakeShore Biopharma, this trial aims to "validate the clinical superiority of the YSJA rabies vaccine" and enhance its market competitiveness.
Rabies: A Global Health Threat
Rabies remains a significant global health concern, with an almost 100% fatality rate upon the emergence of clinical symptoms. The disease claims approximately 59,000 lives annually across more than 150 countries. Transmission via bites from infected dogs accounts for over 95% of human cases, with 40% of deaths occurring in children under 15 years of age. Post-exposure prophylaxis, including vaccination, is critical for preventing fatalities following potential exposure.
LakeShore Biopharma's Commitment
LakeShore Biopharma, formerly known as YS Biopharma, is dedicated to developing and delivering innovative vaccines and therapeutic biologics for infectious diseases and cancer. The YSJA rabies vaccine is a flagship product, with over 100 million doses sold since its market approval. The company's proprietary PIKA immunomodulating technology platform drives the development of new-generation preventive and therapeutic biologics targeting various viral infections, including rabies, coronavirus, hepatitis B, influenza, and shingles.
