Three Highly Anticipated Flagship Upgraded Vaccines Filing for Market Listing; Significant Breakthrough Achieved in the International Market

HONG KONG SAR - Media OutReach Newswire - 28 March 2024 - AIM Vaccine Co., Ltd. (the "Company", together with its subsidiaries,the "Group")is pleased to announce the results for the year ended 31 December 2023 (the "Period"). As of December 31, 2023, AIM Vaccine has obtained a total of 14 clinical approvals and conducted 21 clinical trials. Among them, 5 vaccine varieties have reached the final stage of Phase III clinical trials. The construction of the production workshops for these 5 vaccine products in Phase III is have been substantially completed, and various preparations for market launch are currently underway. In 2024, the company plans to submit market applications for 3 products and initiate clinical applications for 7 other products. During the reporting period, the full course of vaccination in Phase III clinical trial of 13-valent pneumonia conjugate vaccine (PCV13) was completed, and we have submitted the pre-application for marketing registration to the NMPA; the full course of vaccination in the subjects in Phase III clinical trial of 23-valent pneumonia polysaccharide vaccine (PPSV23) and iterative serum-free rabies vaccine was completed; EV71-CA16 bivalent HFMD vaccine (HDC) as a global innovative vaccine which is being developed for the first time worldwide has obtained clinical approvals; and iterative mRNA rabies vaccine is the first nonCOVID-19 mRNA vaccine candidate accepted by relevant authorities in China. According to the announcement, AIM Vaccine has maintained a high level of investment in research and development, with R&D expenses reaching RMB 636.4 million in 2023. This represents a 27.2% increase compared to the same period in 2022. The proportion of R&D revenue stands at 53.6%, positioning the company at the forefront of the industry. Integrating Industry's Finest Resources | Abundant Vaccine Pipeline | Multiple Game-Changing Flagship Products Entering Harvest Season AIM Vaccine is an extremely rare comprehensive vaccine industry group that possesses advantages in four dimensions: pipeline, research and development, production, and sales. Currently, the company has commercialized 8 vaccines targeting 6 disease areas and is developing 21 vaccine candidates. Its pipeline covers the top 10 vaccine varieties worldwide. Notably, the recombinant HBV vaccines and freeze-dried human rabies vaccines are our key commercialized market-leading vaccine products, making AIM Vaccine the largest hepatitis B vaccine manufacturer and the second-largest rabies vaccine manufacturer globally. Among them, the recombinant hepatitis B vaccine is and is expected to continue as a major type of commercialized product for AIM Vaccine. Currently, AIM is the first and only company in China with steady production and approved lot release of HBV vaccines using Hansenula Polymorpha for antigen expression. Since its approval, recombinant HBV vaccine series products have maintained a 100% pass rate in lot release quality audits of NIFDC. With the shift from universal newborn vaccination to vaccination for the entire population, hepatitis B vaccination presents a new growth opportunity for the company. The freeze-dried human rabies vaccine (Vero cell), known for its high quality and stability, remains a key competitive factor in the market. Since its commercialization in 2007, AIM's production of the lyophilized human rabies vaccine (Vero cell) has maintained a 100% approval rate in batch release inspections by the NIFDC for the past 16 years. Following the established corporate strategy of the Company, AIM Vaccine proactively advance the development of the vaccine pipelines and accelerate the research and development of iterative pneumonia series vaccines through on-going technological innovation, achieving new productive forces at an accelerated pace. Leveraging the advantages of the polysaccharide conjugate vaccine technology platform, AIM Vaccine have developed a series of pneumonia vaccines, including: (1) the 13-valent pneumonia conjugate vaccine, which has completed on-site work for Phase III clinical trial and has submitted a pre-application for marketing; (2) the 23-valent pneumonia polysaccharide vaccine, which has also completed Phase III clinical trial and is expected to apply for marketing registration in 2024; (3) the 20-valent pneumonia conjugate vaccine, which has submitted a preapplication for clinical trials; and (4) the 24-valent pneumonia conjugate vaccine, which is being simultaneously developed globally for the first time and has completed preclinical research. In the layout of the rabies vaccine series, AIM is leading the deep technological iteration and upgrade of global rabies vaccines, aiming to provide the market with upgraded and advanced rabies vaccine products that offer better quality, higher safety, and require fewer...