LakeShore Biopharma Approved for Phase III Trial on Simplified YSJA Rabies Vaccine Regimens

GAITHERSBURG, Md., Oct. 25, 2024 -- LakeShore Biopharma Co., Ltd, listed on Nasdaq under the ticker LSB, has announced a significant development in its ongoing efforts to combat infectious diseases and cancer. The global biopharmaceutical company has received approval from China's National Medical Products Administration (NMPA) to conduct a Phase III clinical trial. This trial aims to evaluate the immunogenicity and safety of a simplified four-dose regimen for its YSJA rabies vaccine.

The YSJA rabies vaccine, which has been a cornerstone product for LakeShore Biopharma, has already achieved market success with over 100 million doses sold since its initial approval. The proposed trial will assess two distinct four-dose immunization schedules against the existing five-dose Essen regimen. The new schedules being evaluated are the Zagreb Regimen, which involves two doses initially followed by one dose in each of two subsequent sessions, and the Modified Essen Regimen, which consists of four individual doses.

The trial is designed as a single-center, randomized, double-blind, controlled study. The objective is to determine whether these new schedules are as effective and safe as the traditional Essen regimen. The trial is scheduled to commence in December 2024 and aims to offer more flexible vaccination options, reduce the burden on healthcare providers, and increase patient compliance.

Xu Wang, the Chief Executive Officer of LakeShore Biopharma, emphasized the importance of this milestone. He noted that the trial could significantly enhance the competitiveness of their rabies vaccine in the global market. "By exploring these simplified immunization schedules, we aim to make our vaccine more appealing and accessible, thereby expanding our market presence," said Wang. He expressed optimism that the trial would validate the clinical benefits of the YSJA rabies vaccine and garner increased support from the scientific community and industry players worldwide.

Wang also highlighted the critical role of the YSJA rabies vaccine in preventing rabies-related deaths and disabilities. He indicated that the trial's success would not only strengthen LakeShore Biopharma's position in the Chinese market but also contribute significantly to the global fight against rabies. "We are committed to advancing our rabies vaccine development and ensuring that we remain at the forefront of this field," Wang added.

Rabies is a severe and often fatal disease, with a nearly 100% mortality rate once clinical symptoms appear. The disease causes approximately 59,000 deaths annually across more than 150 countries. A significant majority of these deaths are due to bites from infected dogs, with 40% of the fatalities occurring in children under 15 years old. While rabies is almost always fatal without prompt treatment, post-exposure prophylaxis can effectively prevent death if administered soon after exposure.

LakeShore Biopharma, previously known as YS Biopharma, is a global leader in developing innovative vaccines and therapeutic biologics. The company has developed a proprietary PIKA® immunomodulating technology platform and is focused on creating new treatments for a range of viral infections, including rabies, coronavirus, hepatitis B, influenza, and shingles. Operating in multiple countries, including China, the United States, Singapore, and the Philippines, LakeShore Biopharma is led by a team with extensive experience in the biopharmaceutical sector.

In summary, LakeShore Biopharma's new Phase III clinical trial represents a significant step forward in their mission to improve rabies vaccination protocols. By potentially offering more flexible and cost-effective immunization schedules, the company aims to enhance patient adherence, reduce healthcare burdens, and save more lives from this deadly disease.