AIM VACCINE (06660): The submission for the market registration application of the iterative process high-potency human diploid rabies vaccine has been completed.

AIM VACCINE (06660) announced that it has submitted a listing application to the National Medical Products Administration for its independently developed high-titer human diploid rabies vaccine utilizing an iterative production process. According to the results of the completed phase III clinical trial, the vaccine demonstrates good safety, immunogenicity, and durability of immunity, with superior immunogenicity and durability compared to the control vaccine. All indicators have fully met the evaluation standards set for the clinical trial. This product is an upgraded iteration of the human diploid rabies vaccine, characterized by significantly high efficacy, marking a major technological advancement in the global rabies vaccine field. Rabies is the disease with the highest mortality rate in the world, with a nearly 100% fatality rate once symptoms appear. Currently, there are no effective clinical treatments for rabies, making post-exposure prevention crucial; the primary preventive measure is vaccination with human rabies vaccine. Compared to traditional Vero cell rabies vaccines, human diploid rabies vaccines utilize human diploid cells instead of Vero cells, which are homologous to humans and inherently safer. The price of human diploid rabies vaccines on the market is currently 3 to 5 times higher than that of Vero cell rabies vaccines, thus providing higher product added value. Compared to the traditional first-generation human diploid rabies vaccine, the iterative high-titer human diploid rabies vaccine developed by the Group has first broken through the technical bottleneck of low virus titer and low yield inherent in traditional processes. It has optimized and innovated the purification process, significantly improving product quality and safety. This not only reflects the companys R&D strength but also represents a major breakthrough in the field of high-titer rabies vaccine production globally. China is the largest rabies vaccine market in the world. According to Frost & Sullivan's statistics, driven by product updates and the increasing prevalence of rabies vaccination, the market is expected to reach 14.8 billion yuan by 2030. Compared to traditional rabies vaccination regimens, this product developed by the Group can be administered using the "five-dose method," as well as simplified four-dose methods and "2-1-1 four-dose method," offering greater flexibility and convenience. According to the "Regulations on the Prevention and Treatment of Rabies Exposure (2023 Edition)" established by the National Centers for Disease Control and Prevention and the National Health Commission, rabies vaccination clinics are required to be equipped with at least two different types of rabies vaccines. With its iterative technical advantages and flexible vaccination methods, the Groups product is expected to become the preferred choice for vaccination institutions. The Group has built a workshop for the iterative high-titer human diploid rabies vaccine that fully meets international standards and has completed commercial-scale production validation, demonstrating the capacity for large-scale production of this product. The human diploid rabies vaccine is recommended by the WHO as the gold standard for rabies vaccines and has been widely used in several developed countries. As the world's second-largest supplier of rabies vaccines, the Group is committed to leading in-depth technological iterations and upgrades in global rabies vaccines, providing a series of higher quality and safer rabies vaccine products to the market, further consolidating the Companys leading position in the global rabies vaccine field and promoting sustainable development. The approval of this product in the future will further enrich the Company's product structure, create synergies with the existing rabies vaccine series, and enhance core competitiveness. As part of a global layout, it can contribute additional revenue, strengthen the Company's market position, and provide new momentum for the Companys continuous and stable development.