HONG KONG SAR – Media OutReach Newswire – March 28, 2024 –
AIM Vaccine Co., Ltd. (the society “, with its subsidiaries, the group”) is pleased to announce the results for the financial 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 varieties of vaccines have reached the final stage of Phase III clinical trials. The construction of the production workshops for these 5 vaccine products in Phase III has largely been completed and various preparations for marketing are currently underway. In 2024, the company plans to file marketing applications for 3 products and initiate clinical applications for 7 other products.
During the reporting period, the complete vaccination cycle in the phase III clinical trial of
13-valent conjugate pneumonia vaccine (PCV13) has been completed and we have submitted the pre-application for marketing registration to the NMPA; the complete vaccination cycle in subjects of the phase III clinical trial of
23-valent polysaccharide pneumonia vaccine (PPSV23) and the iterative serum-free rabies vaccine was completed;
EV71-CA16 HFMD bivalent vaccine (HDC) as a global innovative vaccine developed for the first time in the world and having obtained clinical approvals; And
iterative mRNA rabies vaccine is the first non-COVID-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 expenditure reaching RMB 636.4 million in 2023. This represents an increase of 27.2% over the previous year. same period in 2022. The proportion of R&D revenue amounts to 53.6%, positioning the company at the forefront of the industry.
Integrating Iindustry FThere is A.resources | Abundant Vaccine P.ipéline | Several gI am-VSsuspended Fgap P.products Eseizure HAccount Sreason
AIM Vaccine is an extremely rare comprehensive industry group that has 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, recombinant HBV vaccines and freeze-dried human rabies vaccines are our primary market-leading commercialized vaccine products, making AIM Vaccine the largest hepatitis B vaccine manufacturer and the second largest manufacturer of rabies vaccines in the world.
Among them, the 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 regularly produce and release approved batches of HBV vaccines using Hansenula Polymorpha for antigen expression. Since their approval, the HBV Recombinant Vaccine Series products have maintained a 100% pass rate in NIFDC batch release quality audits. With the shift from universal vaccination of newborns to vaccination of the entire population, hepatitis B vaccination presents a new growth opportunity for the company.
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 freeze-dried human rabies vaccine (Vero cell) has maintained a 100% approval rate during NIFDC batch release inspections for the past 16 years.
Consistent with the Company’s established business strategy, AIM Vaccine proactively advances the development of vaccine pipelines and accelerates the research and development of iterative series of pneumonia vaccines through continuous technological innovation, thereby creating new productive forces at an accelerated pace. Leveraging the advantages of polysaccharide conjugate vaccine technology platform, AIM Vaccine has developed a series of pneumonia vaccines, including: (1) 13-valent pneumonia conjugate vaccine, which has completed on-site work for a phase III clinical trial and submitted a pre-marketing 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 pneumonia conjugate vaccine, which is being developed simultaneously for the first time globally and whose preclinical research has been completed.
In the design of the rabies vaccine series, AIM leads the in-depth technology iteration and upgrade of global rabies vaccines, aiming to provide the market with improved and advanced rabies vaccine products that provide better quality, greater 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 the iterative serum-free rabies vaccine has been completed, and various preparatory works for the marketing application of the new drug are underway, expected to be completed in 2024; The CTA for the new, 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.
Accelerate efficient vaccine development with a comprehensive technology platform. Rapid advancement in mRNA technology platform pipeline setup
AIM Vaccine has five proven human vaccine platform technologies covering innovative technologies, such as mRNA vaccines, genetically modified vaccines and combination vaccine technologies, as well as traditional technologies, such as bacterial vaccines and viral vaccines. By leveraging these platforms, we are well positioned to develop a consistent, fit-for-purpose flow that is efficient to manufacture. We have at least one approved product or vaccine candidate at CTA or clinical stage under each platform. Meanwhile, the Company is currently designing the antigen structure and mRNA sequence of vaccines by leveraging artificial intelligence, and is attempting to exploit artificial intelligence to contribute to vaccine research and development processes. In the future, the Company plans to deepen its existing applications and expand its applications in clinical trial data analysis.
Notably, AIM Vaccine’s mRNA technology platform has been validated with clinical trial data involving tens of thousands of subjects. The safety and effectiveness of the platform’s products have been fully demonstrated. AIM Vaccine has developed several COVID-19 mRNA vaccines that have undergone clinical trials, enabling accelerated product development and registration. Within this platform, AIM developed the iterative mRNA rabies vaccine, which is the first nationally accepted non-COVID mRNA vaccine product in China. Two other highly anticipated products, the respiratory syncytial virus (RSV) mRNA vaccine and the shingles mRNA vaccine, are expected to finalize their clinical trial applications in 2024.
Additionally, AIM Vaccine has submitted preliminary applications to the NMPA for clinical trials of the 20-valent pneumonia conjugate vaccine (PCV20), the Haemophilus influenzae type b (Hib) conjugate vaccine, the adsorbed tetanus and quadrivalent influenza virus vaccine (MDCK cells). and a highly effective human diploid 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 currently under development.
Future prospects: strengthening of monopolistic advantage and expansion of the international market in the event of a global shortage of vaccines.
In recent years, China’s vaccine industry has strengthened the monopolistic advantage of vaccines in disease prevention, elevated the status of vaccines in the entire biomedical industry, and facilitated the industrialization of new technologies for biotechnology. and the implementation of related policies, thereby establishing a basis for the long-term development of the vaccine industry. The significant increase in vaccine exports has significantly boosted the confidence of Chinese pharmaceutical companies in international expansion.
In addition, in order to accelerate the promotion of internationalized business, the company has specifically established an international business department to advance the implementation of a series of internationalized presentations, and is ready in all aspects such as overseas marketing authorization, product research and development and manufacturing. . The Company’s vaccine products enter the global market.
At present, the company has various specific overseas markets and has started product registration for sales 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 pipelines with close reference to the needs of the international market. In accordance with the latest vaccine prequalification list of the World Health Organization (2024-2026), the Company rapidly promotes the research and development of 13-valent pneumonia conjugate vaccine and tetravalent meningococcal conjugate vaccine, both being high priority qualified vaccines. In addition, the Company proactively researches and develops RSV vaccine and shingles and herpes zoster vaccine, which are also the two varieties in shortage in the international market. The Company strives to promote the marketing registration and sale of these products in China and abroad, and to obtain prequalification of these vaccines by the World Health Organization.
In terms of products on sale, the HAV vaccine, HBV vaccine and rabies vaccine launched by the Company are products rated as medium priority by the World Health Organization, all of which are well received on the international market.
In terms of production capacity construction, the Company has completed the construction of GMP workshops for iterative pneumonia vaccines and iterative batch rabies vaccines, and all of these workshops meet 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 to fully prepare for the rapid entry into the overseas market of these products as soon as they are marketed.
With the increase in China’s economic power, 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 major products are expected to complete the application process and be launched during the year, which is expected to lead to substantial revenue growth of the company.
Hashtag: #VaccinAIM
The issuer is solely responsible for the content of this announcement.
