AIM's Serum-Free Iterative Rabies Vaccine Phase III Data Meet Clinical Preset Targets

2024-10-07 Source:Economic Information Daily

AIM Vaccine (06660.HK) announced on the evening of October 6 that the company and its subsidiaries (hereinafter collectively referred to as the "group") recently received a notice from the National Institutes for Food and Drug Control regarding the serum antibody detection results of the Phase III clinical trial of the serum-free iterative rabies vaccine. So far, the group's serum-free iterative rabies vaccine Phase III clinical trial data has completed unblinding and statistical analysis work. The study results show that the serum-free iterative rabies vaccine developed by the group has good immunogenicity and good safety, achieving the preset clinical targets.


It is reported that the serum-free iterative rabies vaccine is completely different from the currently available Vero cell rabies vaccine and human diploid cell rabies vaccine containing serum, and is an iteratively upgraded product. The residual animal serum in vaccine products is one of the important factors causing adverse reactions such as allergies in the vaccinated population. The serum-free iterative rabies vaccine developed by AIM Vaccine does not contain animal serum, improving safety and reducing the probability of adverse reactions. So far, there has been no serum-free rabies vaccine approved and launched on the global market, and this product is expected to become the first product to be launched.


AIM has completed the construction of a serum-free iterative rabies vaccine production workshop with production capacity and meeting international standards. As the world's second-largest supplier of rabies vaccines, the group leads the in-depth technical iteration and upgrading of global rabies vaccines. After the launch of the serum-free iterative rabies vaccine product, it will provide the market with better quality and higher safety rabies vaccine products.


At present, AIM has completed the preliminary work for the market registration of the serum-free iterative rabies vaccine, has carried out process verification in the GMP workshop that meets the scale and quality requirements for market launch, and the pre-drug registration inspection results meet quality standards. It is actively promoting the acquisition of the clinical summary report. According to the relevant regulations on national drug registration management, the applicant can submit a drug market registration application to the National Medical Products Administration (NMPA) after obtaining the vaccine clinical research summary report and carrying out process verification in the GMP workshop that meets the scale and quality requirements for market launch.