AIM Vaccine (06660.HK): Serum-Free Iterative Rabies Vaccine Completes Supplementary Data Submission for Registration; NDA Achieves Key Milestone
NewTimeSpace News: AIM Vaccine Co., Ltd. (stock code: 6660) issued a voluntary announcement regarding important progress in the registration application for its serum-free iterative rabies vaccine.
According to the announcement, the group's wholly-owned subsidiary AIM Honor (Ningbo) Biopharmaceutical Co., Ltd. ("AIM Honor") had previously submitted a marketing authorization application to the NMPA for its self-developed serum-free iterative rabies vaccine (application acceptance number: CXSS2500044), and successfully completed on-site inspections. In the first half of 2026, AIM Honor received a supplementary data notice from the CDE of the NMPA, which represents a standard procedure in the vaccine review process. The company has completed the supplementary data submission in accordance with the review comments, marking important progress in the registration application.
The announcement noted that Phase III clinical study results from the completed unblinding demonstrated that the vaccine possesses good safety, immunogenicity, and immune persistence, having fully met the preset clinical trial evaluation criteria. AIM Honor has already obtained the corresponding product manufacturing license for this vaccine. The group believes that the launch of this product will further consolidate its global leading position in the rabies vaccine field.
The announcement explained that rabies has the highest fatality rate of any disease worldwide, with a near 100% mortality rate after onset. Currently, there is no clinically effective treatment for rabies, making post-exposure prophylaxis crucial, with human rabies vaccination being the primary preventive measure. The group's serum-free iterative rabies vaccine achieves innovation in cell culture technology by eliminating any animal serum components throughout the production process, significantly reducing the probability of adverse reactions such as allergies and local reactions caused by animal serum residuals present in conventional Vero cell and human diploid cell rabies vaccines.
China is the world's largest rabies vaccine market. According to CIC statistics, driven by product iteration and increased vaccination coverage, the market is expected to reach RMB 14.8 billion by 2030. Under the "Rabies Exposure Prophylaxis and Treatment Standards (2023 Edition)" issued by the National CDC Administration and National Health Commission, rabies vaccination clinics are required to stock at least two different types of rabies vaccines, positioning the group's product as a preferred choice for vaccination institutions given its iterative technological advantages.
As the world's second-largest rabies vaccine supplier, the group has completed construction of an international-standard serum-free iterative rabies vaccine production facility and completed commercial-scale validation production, possessing the capability for scaled manufacturing and rapid market deployment upon approval. The group believes that future approval and launch of this vaccine is expected to significantly boost the group's performance.
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