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 doses for administration. This will further strengthen the company's competitiveness in the rabies vaccine market. The on-site work of the Phase III clinical trial of iterative serum-free rabies vaccine has been completed, and various preparatory work for the new drug marketing application is underway, which is planned to be completed in 2024; The CTA for the novel-process highly-effective human diploid 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 relevant authorities in China.
Accelerating Efficient Vaccine Development through a Comprehensive Technological Platform. Rapid Advancement in the Pipeline Layout of mRNA Technology Platform
AIM Vaccine have five proven human vaccine platform technologies covering innovative technologies, such as mRNA vaccine, genetically engineered vaccine, and combination vaccine technologies, as well as traditional technologies, such as bacterial vaccine and viral vaccine technologies. Leveraging these platforms, we are well positioned to develop a steady and fit-for-purpose stream of vaccines that are efficient to manufacture. We have at least one approved product or one vaccine candidate at CTA or clinical stages under each platform. At the same time, the Company is currently designing the structure of antigens and mRNA sequence of vaccines leveraging artificial intelligence, and is trying to leverage artificial intelligence to assist in process research and development of vaccines. Looking forward, the Company expects to increase the depth of existing applications and expand its applications in clinical trial data analysis.
Notably, AIM Vaccine's mRNA technology platform has been validated through clinical trial data from tens of thousands of subjects. The safety and efficacy of platform products have been thoroughly demonstrated. AIM Vaccine has developed several mRNA COVID-19 vaccines that have undergone clinical trials, allowing for accelerated development and registration of products. Within this platform, AIM has developed the mRNA iterative rabies vaccine, which is the first non-COVID mRNA vaccine product accepted domestically in China. Two other highly anticipated products, the mRNA respiratory syncytial virus (RSV) vaccine and mRNA herpes zoster vaccine, are expected to complete clinical trial applications in 2024.
Additionally, AIM Vaccine have submitted pre-applications to the NMPA for clinical trials of the Company's 20-valent pneumonia conjugate vaccine (PCV20), haemophilus influenzae type b (Hib) conjugate vaccine, adsorbed tetanus vaccine, quadrivalent influenza virus vaccine (MDCK Cells) and novel-process highly-effective human diploid rabies vaccine. AIM Vaccine has also submitted a preclinical trial application for its quadrivalent MDCK cell-based influenza vaccine, which is currently under development.
Future Outlook: Strengthening Monopoly Advantage and Expanding International Market for Global Vaccine Shortages.
In recent years, the vaccine industry in China has strengthened the monopoly advantage of vaccines in disease prevention, elevated the status of vaccines in the overall biomedical industry, and facilitated the industrialization of new technologies for biotechnology and the implementation of related policies, establishing a foundation for the long-term development of the vaccine industry. The significant increase in exports of vaccines has greatly boosted the confidence of Chinese pharmaceutical companies in their international expansion.
Furthermore, in order to accelerate the promotion of internationalized business, the Company specifically set up an international business department to push forward the implementation of series of internationalized layout, and is ready in all aspects such as overseas marketing permission, product research and development and manufacturing. The Company's vaccine products are entering the global market.
At present, the Company has various specific overseas markets and has begun the registration of marketed products in regions such as Southeast Asia, Africa, South America and the Middle East. The Company's rabies vaccine has obtained the registration licenses in countries such as Pakistan.
In terms of products under development, the Company has set up product pipelines with close reference to the needs of the international market. In accordance with the latest World Health Organization's vaccine prequalification list (2024-2026), the Company is rapidly promoting the research and development of the 13-valent pneumonia conjugate vaccine and the tetravalent meningococcal conjugate vaccine, both being high-priority qualified vaccines. In addition, the Company is proactively researching and developing the RSV vaccine and the shingles/herpes zoster vaccine, both of which are also the varieties in short supply in the international market. The Company is making efforts to promote the marketing registration and sale of these products within and outside China, and to achieve the World Health Organization's prequalification for the vaccines.
In terms of on-sale products, HAV vaccine, HBV vaccine and rabies vaccine launched by the Company are medium-priority qualified products by the Word Health Organization, all of which are welcomed in the international market.
In terms of production capacity construction, the Company has completed construction of GMP workshops for iterative pneumonia series vaccines and iterative rabies series vaccines in batches, and all of these workshops meet the international standards. Phase III clinical samples of 13-valent pneumonia conjugate vaccine and 23-valent pneumonia polysaccharide vaccine are produced in these workshops, helping the Company get fully ready for the quick entry into the overseas market of such products upon marketing.
With the increase in China's economic strength, the biopharmaceutical industry, including the vaccine sector, has been identified as a strategic emerging industry and is encouraged and supported by the national government. Therefore, AIM Vaccine has entered a period of intense application for major upgraded products in 2024. Three significant products are expected to complete the application process and be launched within the year, which is projected to drive substantial revenue growth for the company.
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About AIM Vaccine Co., Ltd.
AIM Vaccine (stock code: 06660) is committed to manufacturing conscientious vaccines and promoting the health of the people. It is the second-largest vaccine group in China and the largest private-sector vaccine group, with a complete industry chain. AIM Vaccine is a leading company in the Chinese vaccine industry and one of the top players in the mRNA vaccine field. As one of the most strictly regulated industries in the country, China has over 40 vaccine production qualifications nationwide. Currently, AIM Vaccine owns four wholly-owned licensed vaccine production companies and three vaccine research institutes. It is one of the only two human vaccine companies in China with strategic resources such as P3 laboratories. AIM Vaccine is also the world's largest manufacturer of hepatitis B vaccines and the second-largest manufacturer of rabies vaccines globally.
AIM Vaccine has a portfolio of eight commercialized vaccines and 21 vaccines under development, covering the top ten vaccine varieties globally. Its commercialized products have maintained a leading market position for a long time, with sales covering all 31 provinces, municipalities, and autonomous regions in China, reaching over 2,000 district and county-level disease control centers.
source: AIM Vaccine
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