Policy & Regulation
LakeShore Biopharma's Phase III YSJA Rabies Vaccine clinical trial receives Chinese NMPA approval
28 October 2024 -

Biopharmaceutical company LakeShore Biopharma Co., Ltd (Nasdaq: LSB) announced on Friday that it has received approval from the National Medical Products Administration (NMPA) in China for a Phase III clinical trial of its YSJA rabies vaccine. The trial will explore the immunogenicity and safety of a simplified four-dose regimen.

LakeShore Biopharma's YSJA rabies vaccine, which has sold over 100 million doses since approval, aims to offer more immunization options, reduce physician workload, and improve patient adherence.

Scheduled to begin in December 2024, the trial will compare two four-dose regimens: the Zagreb Regimen (2-1-1) and the Modified Essen Regimen (1-1-1-1). This single-centre, randomized, double-blind, controlled study will evaluate these new schedules against the existing five-dose Essen regimen (1-1-1-1-1).

Both new regimens offer greater flexibility and have the potential to enhance the standard of rabies care.

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