NEWS
LakeShore Biopharma Granted Phase III Clinical Trial Approval to Explore Simplified Regimens for YSJA Rabies Vaccine
GAITHERSBURG, Md., Oct. 25, 2024 /PRNewswire/ -- LakeShore Biopharma Co., Ltd (Nasdaq: LSB) ("LakeShore Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced that it has been granted approval for a Phase III clinical trial (the "Trial") by the National Medical Products Administration (NMPA) in China to explore the immunogenicity and safety of a simplified four-dose regimen for its YSJA rabies vaccine which is the first generation of the Company's rabies vaccine and has sold more than 100M doses since its market approval. This simplified immunization schedule has the potential to provide patients with more immunization options, reduce physician workload, minimize hospital visits, improve patient adherence to vaccination and also reduce the financial burden on patients under comparable immunogenicity, boosting the vaccine's utility and aiding in the prevention of rabies deaths.
The Trial, which is expected to begin in December 2024, will evaluate the immunogenicity and safety of the YSJA rabies vaccine across two distinct four-dose immunization schedules to determine their immunogenicity and safety compared to the existing Essen regimen (1-1-1-1-1). It will be a single center, randomized, double-blind, controlled study. The two four-dose immunization regimens which will be explored are the Zagreb Regimen (2-1-1), which involves two shots in the first session and one shot each across two subsequent sessions; and the Modified Essen Regimen (1-1-1-1), which involves four sessions of a single shot each. Compared to the conventional five-dose, Essen regimen (1-1-1-1-1), both options offer greater flexibility for medical professionals and patients and stand to improve the existing standard of rabies care.
The Trial, which is expected to begin in December 2024, will evaluate the immunogenicity and safety of the YSJA rabies vaccine across two distinct four-dose immunization schedules to determine their immunogenicity and safety compared to the existing Essen regimen (1-1-1-1-1). It will be a single center, randomized, double-blind, controlled study. The two four-dose immunization regimens which will be explored are the Zagreb Regimen (2-1-1), which involves two shots in the first session and one shot each across two subsequent sessions; and the Modified Essen Regimen (1-1-1-1), which involves four sessions of a single shot each. Compared to the conventional five-dose, Essen regimen (1-1-1-1-1), both options offer greater flexibility for medical professionals and patients and stand to improve the existing standard of rabies care.
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