LakeShore Biopharma Launches First Needle-Free Rabies Vaccine Reconstitution System in China
LakeShore Biopharma has received regulatory approval for a novel packaging solution for its YSJA™ rabies vaccine featuring needle-free reconstitution technology, with nationwide distribution in China beginning within weeks.
LakeShore Submits BLA to DRAP for PIKA Rabies Vaccine Following Positive Phase III Results
• LakeShore Biopharma has initiated the BLA submission to Pakistan's DRAP for its PIKA Rabies Vaccine, targeting post-exposure prophylaxis. • Phase III trial data supports the application, demonstrating the vaccine's ability to accelerate protection against rabies. • The trial met primary immunogenicity endpoints, showing a rapid seroconversion rate and a tolerable safety profile. • PIKA Rabies Vaccine utilizes LakeShore’s PIKA adjuvant technology to elicit a stronger, faster immune response.
LakeShore Biopharma Seeks Approval for PIKA Rabies Vaccine in Pakistan After Positive Phase 3 Results
• LakeShore Biopharma has initiated a Biologics License Application (BLA) with Pakistan's Drug Regulatory Authority for its PIKA rabies vaccine. • Phase 3 trial data demonstrated the vaccine's ability to provide accelerated protection in a one-week regimen, compared to the standard three- or four-week regimens. • The trial, involving 4,500 participants, showed superior immunogenicity and safety, addressing a critical need in a country with high rabies prevalence. • PIKA rabies vaccine utilizes proprietary PIKA adjuvant technology to produce a robust immune response, and has received FDA orphan drug designation.
LakeShore Biopharma's YSJA Rabies Vaccine Enters Phase III Trial with Simplified Regimens
LakeShore Biopharma's YSJA rabies vaccine will be evaluated in a Phase III trial in China using simplified four-dose regimens.
LakeShore Biopharma's YSJA Rabies Vaccine Enters Phase III Trial with Simplified Regimen
LakeShore Biopharma's YSJA rabies vaccine has received approval for a Phase III clinical trial in China to assess a simplified four-dose regimen.
LakeShore Biopharma's YSJA Rabies Vaccine to Enter Phase III Trial with Simplified Regimens
LakeShore Biopharma received approval for a Phase III clinical trial in China to assess simplified four-dose regimens of its YSJA rabies vaccine.
LakeShore Biopharma's Rabies Vaccine Enters Phase III Trial with Simplified Regimen
LakeShore Biopharma's YSJA rabies vaccine receives approval for a Phase III clinical trial in China to assess simplified four-dose regimens.
LakeShore Biopharma's YSJA Rabies Vaccine Enters Phase III Trial in China with Simplified Regimens
LakeShore Biopharma received approval from China's NMPA for a Phase III trial of its YSJA rabies vaccine, aiming to simplify the immunization schedule.
LakeShore Biopharma's YSJA Rabies Vaccine Approved for Phase III Trial in China
LakeShore Biopharma's YSJA rabies vaccine has received approval from China's NMPA for a Phase III clinical trial exploring a simplified four-dose regimen.