Phase III clinical data of AIM Vaccine iterative serum-free rabies vaccine reaches preset goals
It is expected to become the world’s first heavyweight iteration of a major item to be launched on the market
HONG KONG SAR - Media OutReach Newswire - 7 October 2024 - AIM Vaccine announced on the evening of October 6 that the company has received notification from the National Institutes for Food and Drug Control on the serum antibody test results of the phase III clinical trial of the iterative serum-free rabies vaccine.The unblinding and statistical analysis of the phase III clinical trial data have been completed. The results showed that the vaccine had good immunogenicity and safety, and reached the preset clinical goals. At present, no serum-free rabies vaccine has been approved for marketing in the global market, the product is expected to become the world's first listed iteration of the big single product, becoming a milestone of major technological innovation in the industry.
According to the announcement, the iterative serum-free rabies vaccine has completed the preliminary work for marketing registration, and has undergone process verification in the GMP workshop that meets the marketing scale and quality requirements. The pre-inspection results for drug registration meet the quality standards. The company will submit the application for listing registration of the product as soon as possible.
Completely unlike the existing Vero cell rabies vaccine containing serum and human diploid rabies vaccine containing serum, the iterative serum-free rabies vaccine is an iterative product. Animal serum residues in vaccine products are one of the important factors leading to adverse reactions such as allergies in vaccinated populations, and the iterative serum-free rabies vaccine developed by the Company does not contain animal serum, which significantly improves safety and reduces the probability of adverse reactions.
According to the company's 2024 interim report, with respect to rabies vaccines in China, the approved lot release volume increased from 58.80 million in 2019 to 78.50 million in 2021, representing an increase of 33.6%. It is expected that the market scale will increase to RMB22.0 billion by 2030. This is mainly Benefit from the iterative upgrade of rabies vaccine products. Meanwhile, the development of serum-free rabies vaccines will also drive market growth. It has adopted the serum-free cell cultivation technology and has more stable compositions and higher safety, and it is expected that the technology will account for approximately 35.0% of the rabies vaccine market in China by 2030.
This year is a year of intensive application for Aimi vaccines. Three heavyweight single-product vaccines, including iterative serum-free rabies vaccine, are accelerating their application for listing. The accelerated launch process of new products is expected to become a new performance growth point for the company.
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