(MENAFN- Media OutRevery one Newswire) HONG KONG SAR – Media OutRevery one Newswire – March 28, 2024 – AIM Vaccine Co. , Ltd. (the “Company”, in combination with its subsidiaries, the “Group”) is pleased in announcing the effects for the monetary year ending December 31, 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, five types of vaccines have reached the end point of phase III clinical trials. The design of the production workshops for these five vaccine products in phase III has been largely completed and various agreements are currently being carried out for their placement on the market. In 2024, the company plans to introduce market placement programs for three products and initiate clinical programs for seven more products. During the reporting era, the full course of vaccination in the phase III clinical trial of pneumonia 13-valent conjugate vaccine (PCV13) was completed and we submitted the pre-application for market placement registration of NMPA; The full course of vaccination of subjects in the Phase III clinical trial of 23-valent polysaccharide pneumonia vaccine (PPSV23) and iterative serum-free rabies vaccine has been completed; The HFMD (HDC) EV71-CA16 bivalent vaccine, as a global breakthrough vaccine developed for the first time in the world, has obtained clinical approvals; and the iterative mRNA rabies vaccine is the first non-COVID-19 mRNA vaccine candidate accepted by the relevant government in China. According to the announcement, AIM Vaccine has maintained a peak investment in studies and progression, with R&D expenditure around RMB 636. 4. million in 2023. This represents an increase of 27. 2% compared to the same period in 2022. The proportion of R&D profits increases to 53. 6%, positioning the company at the forefront of the industry. Integrate the most productive resources in the industry | Abundant portfolio of vaccines | Several game-changing blockbuster products enter the harvest season. AIM Vaccine is a comprehensive and incredibly rare vaccine industry organization that has merits in 4 dimensions: pipeline, studies and progression, production and sales. Currently, the company has commercialized eight vaccines targeting six disease areas and is developing 21 vaccine candidates. Its portfolio covers the 10 smartest types of vaccines worldwide. In particular, recombinant HBV vaccines and freeze-dried human rabies vaccines are our market-leading number one marketed vaccine products, making AIM Vaccine the largest manufacturer of hepatitis B vaccines and the second largest largest manufacturer of rabies vaccines in the world. Among them, recombinant hepatitis B vaccine is and is expected to remain a major type of marketed product for the AIM vaccine. Currently, AIM is the first and only company in China to produce and launch approved batches of HBV vaccines using Hansenula Polymorpha for antigen expression. Since approval, recombinant HBV vaccine series products have maintained a one hundred percent pass rate in NIFDC lot release quality audits. With the move from universal vaccination of newborns to vaccination of the entire population, hepatitis B vaccination presents a new expansion opportunity for the company. The freeze-dried human rabies vaccine (Vero cells), known for its quality and stability, remains a key competitive player. thing in the market. Since commercialization in 2007, AIM’s production of freeze-dried human rabies vaccine (Vero Cell) has maintained a one hundred percent approval rate during NIFDC lot release inspections for the past 16 years. In line with the Company’s established business strategy, AIM Vaccine has taken proactive measures to advance the progression of vaccine projects and drive the studies and progression of iterative series of pneumonia vaccines through continuous technological innovation, thus creating new productive forces at an accelerated pace. speed up the pace. Leveraging the merits of the polysaccharide conjugate vaccine generation platform, AIM Vaccine has developed a series of pneumonia vaccines, adding: (1) the 13-valent pneumonia conjugate vaccine, which completed the in situ tables for a trial phase III clinical trial and presented a preliminary trial. market placement application; (2) the 23-valent polysaccharide pneumonia vaccine, which has also completed its Phase III clinical trial and is expected to apply for market registration in 2024; (3) the 20-valent conjugate pneumonia vaccine, which has submitted a pre-application for clinical trials; and (4) the 24-valent conjugate pneumonia vaccine, which is being developed simultaneously for the first time globally and has completed preclinical studies. In the design of the rabies vaccine series, AIM leads the deep generation iteration and updating of rabies vaccines globally. Set aimed at providing the market with advanced and complex rabies vaccine products, which provide higher quality, greater protection and require fewer doses for administration. This will further strengthen the company’s competitiveness in the rabies vaccine market. On-site work on the phase III clinical trial of the iterative serum-free rabies vaccine has been completed and various preparatory works are underway for the commercialization of the new drug, which is expected to be completed in 2024; The CTA for the new highly effective diploid human rabies vaccine is expected to be submitted in 2024; and the iterative mRNA rabies vaccine is the first non-COVID-19 mRNA vaccine candidate accepted by the relevant government in China. Accelerate effective vaccine progression with an end-to-end generation platform. Rapid progress in setting up mRNA generation platform pipeline AIM Vaccine has demonstrated five human vaccine platform technologies covering cutting-edge technologies such as mRNA vaccine, genetically modified vaccine and mixed vaccines as well as classical technologies , such as the bacterial vaccine and the viral vaccine. technologies. By leveraging those platforms, we are well placed to expand a consistent, fit-for-purpose, and effective flow to manufacture. We have at least one approved product or vaccine candidate at CTA or clinical point on each platform. Meanwhile, the Company is currently designing antigen design and mRNA vaccine series by leveraging artificial intelligence, and is attempting to exploit artificial intelligence to contribute to vaccine studies and progression procedures. Looking ahead, the company plans to deepen existing programs and expand its clinical trial data analysis systems. In particular, AIM Vaccine’s mRNA generation platform has been validated through clinical trials of tens of thousands of subjects. The protection and effectiveness of the platform’s products has been fully demonstrated. AIM Vaccine has developed several COVID-19 mRNA vaccines that have undergone clinical trials, accelerating product progression and registration. Within this platform, AIM developed the iterative mRNA rabies vaccine, which is the first nationally accepted non-COVID mRNA vaccine in China. Two other highly anticipated products, the respiratory syncytial virus (RSV) mRNA vaccine and the shingles mRNA vaccine, are expected to complete their clinical trial programs in 2024. In addition, AIM Vaccine has submitted pre-NMPA programs for clinical trials of 20 conjugates. pneumonia vaccine (PCV20), Haemophilus influenzae type b conjugate vaccine (Hib), adsorbed tetanus vaccine, quadrivalent influenza virus vaccine (MDCK cells) and highly effective diploid human rabies vaccine using a new method. AIM Vaccine has also submitted a preclinical trial application for its MDCK cell-based quadrivalent influenza vaccine, which is lately in progress. Future prospects: strengthening monopolistic merit and expanding the foreign market in the event of a global vaccine shortage. In recent years, China’s vaccine industry has strengthened the monopolistic merit of vaccines in disease prevention, increased the prestige of vaccines in the entire biomedical industry, and facilitated the industrialization of new technologies for biogeneration. and the implementation of similar policies, thus building a foundation for the long-term progression of the vaccine industry. The significant increase in vaccine exports has particularly boosted Chinese pharmaceutical corporations’ confidence in overseas expansion. Furthermore, to boost the promotion of foreign business, the Company has particularly established a foreign business branch to advance the implementation of a series of foreign designs and is in position in all facets, such as authorization of placement in foreign markets, product studies and progression and manufacturing. The company’s vaccine products enter the global market. Currently, the company has several express markets abroad and has begun to register products for sale in regions such as Southeast Asia, Africa, South America and the Middle East. The company’s rabies vaccine has obtained registration licenses in countries such as Pakistan. In terms of products under development, the Company has established product portfolios with close reference to the wishes of the foreign market. In accordance with the most recent World Health Organization vaccine prequalification list (2024-2026), the Company immediately publicizes the studies and progression of the 13-valent pneumonia conjugate vaccine and the quadrivalent meningococcal conjugate vaccine, both vaccines being rated with the highest priority. In addition, the company proactively studies and expands the RSV vaccine and the shingles and shingles vaccine, which are also the two types that are in short supply in the overseas market. The Company strives to advertise the market by placing the registration and sale of those products in China and abroad, and downloading the World Health Organization prequalification for vaccines. In terms of products for sale, the HAV vaccine, HBV vaccine and rabies vaccine introduced through the Company offer products classified as medium priority through the World Health Organization, all of which They are welcome in the foreign market. In terms of production capacity design, the company has completed the design of GMP painting workshops for iterative pneumonia vaccines and iterative batch rabies vaccines, and all of those workshops meet foreign standards. These workshops produce phase III clinical samples of the 13-valent pneumonia conjugate vaccine and the 23-valent pneumonia polysaccharide vaccine, helping the company to fully prepare for the immediate access of these products to the market. abroad as soon as they are placed on the market. . With its strength, the biopharmaceutical industry, adding the vaccine sector, has been known as an emerging strategic industry and is promoted and supported through the national government. Therefore, AIM Vaccine has entered an era of intense application of improved primary products in 2024. Three primary products are expected to complete the application procedure and be introduced during the year, which is expected to lead to very strong profit expansion. company wide. 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