On August 29, the Hong Kong-listed company AIM Vaccine (06660.HK) announced that the company had submitted pre-applications for clinical trials of mRNA RSV (respiratory syncytial virus) vaccine and mRNA shingles vaccine to the U.S. Food and Drug Administration (FDA) for the first time in August 2024. Prior to this, pre-clinical trial applications had been submitted to the Center for Drug Evaluation(CDE), NMPA in June 2024. This is an important step for AIM Vaccine to enter the international market with blockbuster innovative single-item vaccines.

The interim report for 2024 released by AIM Vaccine at the same time shows that the operating income in the first half of the year was 537 million yuan, which was basically the same as the same period last year, and the loss was significantly reduced. As of June 30, 2024, the company had obtained 14 clinical permits and carried out 21 clinical trials. The 13-valent pneumococcal conjugate vaccine, serum-free iterative rabies vaccine and 23-valent pneumococcal polysaccharide vaccine, three blockbuster iterative single-item vaccines, are accelerating the marketing registration work and entering the sprint stage. Many products are accelerating the pace of application for marketing, and the inflection point of performance is emerging.

Among them, the 13-valent pneumococcal conjugate vaccine has completed the marketing pre-application, and the pre-drug registration inspection results meet the quality standards. The basic phase has been unblinded and statistics have been completed, and the marketing registration work is being accelerated; the serum-free iterative rabies vaccine has completed the Phase III clinical trial site work, and the pre-drug registration inspection results meet the quality standards, and it is about to enter the unblinding and statistical work phase; the 23-valent pneumococcal polysaccharide vaccine (PPSV23) has completed the Phase III clinical trial site work and is in the preparation stage before locking the library, about to unblind for statistical analysis. At the same time, the production workshops for the 13-valent pneumococcal conjugate vaccine, iterative serum-free rabies vaccine, and 23-valent pneumococcal polysaccharide vaccine have been established, fully preparing for the marketing and sales of related products domestically and internationally.

In addition, AIM Vaccine has completed the clinical trial pre-applications for five vaccine products, namely mRNA RSV vaccine (respiratory syncytial virus vaccine), mRNA shingles vaccine, 20-valent pneumococcal conjugate vaccine (PCV20), novel process high-efficacy human diploid cell rabies vaccine, and Haemophilus influenzae type b (Hib) conjugate vaccine. Two other blockbuster innovative vaccines, namely quadrivalent MDCK cell influenza virus vaccine and adsorbed tetanus vaccine, have also completed CDE clinical trial applications.

It is worth noting that AIM Vaccine has submitted clinical trial pre-applications for mRNA RSV (respiratory syncytial virus) vaccine and mRNA shingles vaccine to CDE, and also submitted clinical trial pre-applications for mRNA RSV vaccine and mRNA shingles vaccine to the U.S. FDA.

According to AIM Vaccine's announcement, if the two mRNA vaccines can pass the strict review and recognition of the FDA, they will not only obtain the endorsement of international authoritative institutions, providing stronger evidence for their safety and effectiveness, but also become a pass for accelerating clinical trials in multiple countries and regions around the world, which is expected to greatly promote the globalization process of AIM Group's products and rapidly respond to global public health needs.

It is reported that there is currently no mRNA shingles vaccine approved for marketing internationally, and there is no RSV vaccine approved for marketing in China. The two mRNA vaccines mentioned above by AIM are both aiming at a broad blue ocean.

Public information shows that AIM Vaccine is one of the earliest enterprises in China to develop mRNA vaccine products and is also one of the first domestic vaccine enterprises to obtain independent patents for mRNA technology, with a mature mRNA vaccine R&D system, having developed several mRNA candidate vaccines (including but not limited to mRNA rabies vaccine, mRNA RSV vaccine, mRNA shingles vaccine, etc.). AIM Vaccine has now opened up the entire lifecycle process of mRNA vaccine R&D and production, and can quickly achieve the industrialization of mRNA vaccine products after obtaining clinical permission, accelerating the commercialization process of vaccine products.

According to the announcement, AIM Vaccine officially submitted the adsorbed tetanus vaccine to the Center for Drug Evaluation (CDE), NMPA in August 2024. AIM Vaccine is actively promoting the R&D of the adsorbed acellular pertussis-diphtheria-tetanus-Haemophilus influenzae type b (HIB) combination vaccine (referred to as the "quadrivalent vaccine"), and is expected to submit clinical trial applications for the quadrivalent vaccine and its various component vaccines successively starting from 2024. The quadrivalent vaccine is used to prevent whooping cough, diphtheria, tetanus, and invasive infections caused by Haemophilus influenzae type b, with the advantages of reducing the number of vaccinations for infants and young children and enhancing the vaccination compliance of parents, infants and young children.

Multivalent vaccines are the development trend of the industry. According to data from industry consultant China Insights Consultancy (CIC), the domestic multivalent vaccine market size was 6.457 billion yuan in 2022, and it is expected to reach 9.572 billion yuan by 2030, which will enhance the company's core competitiveness, strengthen the company's market position, and provide strong support for the company's continuous and stable development.

In the first half of the year, AIM Vaccine also integrated the innovation spirit into the quality improvement of commercialized vaccines. The company has successively launched a series of full-process temperature monitoring products for vaccines, covering freeze-dried human rabies vaccine, recombinant hepatitis B vaccine (Hansen yeast), quadrivalent meningococcal polysaccharide vaccine (MPSV4), and inactivated hepatitis A vaccine (human diploid cell), to meet the needs of more differentiated customers, provide a variety of specifications for different customers, and better vaccine temperature control and identification, further upgrading the quality management level of vaccines and enhancing the market competitiveness of products.

In terms of internationalization, AIM Vaccine has also made new breakthroughs and progress in the first half of the year. The company has started the registration work of launched products in Southeast Asia, Africa, South America, the Middle East, and other regions; the rabies vaccine has been sent to Côte d'Ivoire and Pakistan, making new progress in developing the Belt and Road market; the quadrivalent meningococcal polysaccharide vaccine has been successfully exported to Egypt and Tajikistan to help prevent and control meningococcal meningitis; the company signed a memorandum of cooperation with representatives from Pakistan to promote the sales of commercialized vaccine products in Pakistan.