AIM Rongyu (Ningbo) Biopharmaceutical Co., Ltd. (艾美榮譽(寧波)生物製藥有限公司), a wholly-owned subsidiary of the Group, has recently obtained the production license for the iterative serum-free rabies vaccine, and will submit an application for drug marketing registration. At present, there is no serum free rabies vaccine that has been approved for launch in the global market, and this product is expected to be the first one on the market, marking a major technological breakthrough for the Group and further cementing the Group’s leading position in the global rabies vaccine industry.

According to the results of the Phase III clinical trials, which have completed unblinding, the Group’s iterative serum-free rabies vaccine has demonstrated good safety, immunogenicity and immune persistence, fully meeting the pre-defined evaluation criteria for the clinical trials.

Rabies is the most deadly disease in the world, with a fatality rate of nearly 100%. Currently, there is a lack of effective treatment for rabies in clinical practice. Therefore, post-exposure prevention is crucial, and the main preventive measure is vaccination against human rabies. 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 globally yet. The mainstream Vero cell rabies vaccine and human diploid rabies vaccine currently available in the market are serum-containing rabies vaccines.

Completely unlike the traditional Vero cell rabies vaccine and human diploid rabies vaccine, the iterative serum-free rabies vaccine developed by the Group is an iterative upgraded product. Animal serum residues in vaccine products is 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 Group does not contain animal serum, which significantly improves safety and reduces the probability of adverse reactions.

China is the largest rabies vaccine market globally. According to China Insights Consultancy, driven by product innovation and iteration, and increased accessibility to rabies vaccines, the market size is projected to reach RMB14.8 billion by 2030. In accordance with the “Guidelines for the Prevention and Treatment of Rabies Exposure (2023 Edition)” (《狂犬病暴露預防處置工作規範》(2023年版)) issued by the National Disease Control and Prevention Administration and the National Health Commission, rabies prevention and treatment clinics should be equipped with at least two different types of rabies vaccines. Leveraging its iterative technological advantages, the Group’s product is expected to become the first choice for vaccination institutions.

As the world’s second largest supplier of rabies vaccines, the Group is committed to leading the in-depth technology iteration and upgrading of rabies vaccines globally. It has completed the construction of an iterative serum-free rabies vaccine workshop that meets international standards, as well as the commercial-scale validation production, and is now capable of producing this product on a large scale. Once the product is approved, it can be rapidly launched into the market.