Application for clinical trial of AIM Vaccine’s human diploid rabies vaccine

According to the announcement, the i iterative-process highly-effective human diploid rabies vaccine developed by AIM Vaccine shows an iterative upgrade compared to the traditional human diploid rabies vaccines of the first generation in many aspects.

The iterative-process highly-effective human diploid rabies vaccine developed by the Company has taken the lead in breaking through the technical bottlenecks of low virus titer and low yield in the traditional process. It has been optimized and innovated in the purification process with the product quality and safety significantly improved.

Compared with the number of traditional rabies vaccinations, this product developed by the Group can be vaccinated with either "five-needle approach", "simple four-needle approach" or "2-1-1 four-needle approach", which is more flexible and convenient.

There are two kinds of rabies vaccines, namely the serum-containing rabies vaccine and the serum-free rabies vaccine. However, no serum-free rabies vaccine has been registered or marketed yet. The mainstream Vero cell rabies vaccine and human diploid rabies vaccine currently available in the market are serum-containing rabies vaccines.

Compared with the traditional Vero cell rabies vaccines, human diploid rabies vaccine uses human diploid cells instead of Vero cells, which are homologous to humans and have a natural safety advantage. The human diploid rabies vaccine currently available in the market is 3 to 5 times more expensive than the Vero cell rabies vaccine, with higher product added value.

According to the announcement, AIM Vaccine has completed the construction of an iterative-process high-efficiency human diploid rabies vaccine workshop that meets international standards, and has completed the production of commercial-scale Phase III clinical trial samples, which is capable of producing this product in large scale.

China is the world's largest rabies vaccine market. According to the 2024 interim performance report of AIM Vaccine, the approved lot release volume of China's rabies vaccines 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, partially due to the iteration of rabies vaccine products upgrade. With the expansion of the pet market and the popularization of pre-exposure immunity knowledge, it is expected that the demand for human rabies vaccines will continue to grow in the future.