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,  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.

Mr. Xu Wang, Chief Executive Officer of LakeShore Biopharma, commented, "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. By evaluating simplified immunization schedules, we aim to make our vaccine more competitive in the rapidly expanding rabies vaccine market. 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."

"The YSJA rabies vaccine is our flagship product and has already proven to be a game-changer in preventing deaths and disabilities related to rabies," Mr. Wang continued. "The potential impact of this clinical trial, combined with our efforts to become a leading rabies vaccine supplier, strengthens our confidence in continuing expanding our market share in China. We are proud to be making another critical contribution to the global fight against this disease, and are eager to forge ahead as a leading innovator in rabies vaccine development."

Rabies has an almost 100% fatality rate upon emergence of clinical symptoms. Each year, it claims the lives of approximately 59,000 individuals in more than 150 countries. Transmission through bites from infected dogs accounts for over 95% of rabies-related fatalities, and 40% of these deaths occur in children under the age of 15. Although rabies is typically lethal without treatment, the administration of post-exposure prophylaxis can effectively prevent fatalities when initiated following possible exposure.