The long-term effect is becoming apparent,AIM Vaccine's 3 blockbuster vaccines accelerate to market, and 2 mRNA vaccines aim at the global market

2024-09-02 Source:The Time Weekly

In the first half of the year, AIM Vaccine actively promoted the development of the vaccine product pipeline according to the established strategy, and through continuous technological innovation, rapidly promoted the R&D of the iteratively upgraded pneumonia vaccine series, accelerating the realization of new quality production forces.


On August 29, AIM Vaccine (06660.HK) released the performance for the first half of 2024. Financial data shows that in the first half of this year, AIM Vaccine recorded revenue of 537 million yuan, which was basically the same as the same period last year, and the loss was significantly reduced.


The year 2024 is a year for AIM Vaccine to concentrate on the market registration and application of the product pipeline. The company is accelerating its efforts in the commercialization of  blockbuster single-item products and is also continuously accelerating in the R&D of innovative vaccines.


At present, AIM Vaccine is fully preparing to practice the company's long-term strategy, and the high-intensity R&D investment in the early stage is about to enter the harvest period.


The Three Major Explosive Vaccines are Sprinting to Market


In the first half of the year, AIM Vaccine actively promoted the development of the vaccine product pipeline according to the established strategy, and through continuous technological innovation, rapidly promoted the R&D of the iteratively upgraded pneumonia vaccine series, accelerating the realization of new quality production forces.


The semi-annual report disclosed that among the three blockbuster single-item vaccines rushing to market this year, the 13-valent pneumococcal conjugate vaccine has submitted a marketing pre-application, the serum-free iterative rabies vaccine has completed the Phase III clinical trial site work, the pre-drug registration inspection results meet quality standards, and it is about to enter the unblinding and statistical work, and plans to submit a market registration application. The 23-valent pneumococcal polysaccharide vaccine also plans to submit a marketing registration pre-application. The production workshops for these three vaccines have been established, and after the subsequent products are approved and launched, they will further expand the revenue volume.


The serum-free iterative rabies vaccine is expected to fill the market gap. It is completely different from the Vero cell rabies vaccine and human diploid cell rabies vaccine containing serum that are already on the market. The characteristic of no animal serum significantly improves the safety of the product. There is no serum-free rabies vaccine approved and launched globally so far.

At present, the high-end rabies vaccines approved in China are only human diploid cell rabies vaccines, and there are only two approved companies. Referring to the pricing of human diploid cell rabies vaccine at 1,500 yuan per person, if AIM Vaccine prices it between 1,500 yuan and 1,700 yuan, it will be very competitive. The rabies vaccine market scale is expected to grow to 22 billion yuan by 2030.


Currently, AIM Vaccine has completed the clinical trial pre-applications for five vaccine products, including mRNA RSV (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.


On the same day of this semi-annual report release, AIM Vaccine announced that the clinical trial applications for two vaccine products from the Center for Drug Evaluation (CDE), NMPA have been officially submitted, namely quadrivalent MDCK cell influenza virus vaccine and adsorbed tetanus vaccine.


AIM Vaccine's many R&D pipelines are advancing in parallel. According to the data disclosed in the semi-annual report, AIM Vaccine has laid out 22 vaccines under development for 14 disease areas, and so far, nine varieties have obtained a total of 14 clinical permits and carried out 21 clinical trials.


Commercialized Vaccine Quality Upgrade


As China's largest full-industry-chain private vaccine group and also the domestic private vaccine manufacturer with the most certified varieties, AIM Vaccine covers the entire value chain from R&D to manufacturing to commercialization, possessing five proven human vaccine technology platforms, including mRNA, covering the main vaccine technology routes encouraged by the state for development.


It is worth noting that in the semi-annual report, AIM Vaccine mentioned that the company has successively launched a series of full-process temperature monitoring products for vaccines to ensure the safety and effectiveness of vaccines, covering freeze-dried human rabies vaccine (Vero cell), recombinant hepatitis B vaccine (Hansen yeast), A, C, Y, and W135 group 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.


Accelerating the Exploration of Overseas Markets


In the tide of going global, AIM insists on "going out" with innovation and strength.

AIM Vaccine has not only laid out an mRNA rabies vaccine on the mRNA technology platform, but according to the company's announcement released on the 29th, two other blockbuster single-item mRNA RSV and mRNA shingles vaccines have also been simultaneously submitted to the Center for Drug Evaluation (CDE), NMPA and the U.S. FDA for clinical trials.


The announcement shows that the submission of the clinical trial pre-application to the U.S. FDA is due to the good data shown by the two mRNA vaccines in animal trials compared to the marketed control vaccines, highlighting the strong strength of AIM Vaccine's mRNA technology platform.


If the above two mRNA vaccines are successful in their clinical applications in the United States, they will not only gain 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. This move can greatly promote the globalization process of the group's products and rapidly respond to global public health needs.


For commercialized vaccine products, AIM Vaccine has also accelerated the implementation of a series of international layouts, and has made comprehensive preparations in overseas marketing authorization, product R&D and production.


The company has started the registration work of launched products in Southeast Asia, Africa, South America, the Middle East, and other regions. Its rabies vaccine has obtained registration permits from countries such as Pakistan, and in the first half of this year, the rabies vaccine was sent to Côte d'Ivoire and Pakistan. In June this year, AIM Vaccine announced the signing of a memorandum of cooperation with representatives from Pakistan to promote the sales of commercialized vaccine products in Pakistan. In addition, the quadrivalent meningococcal polysaccharide vaccine was also successfully exported to Egypt and Tajikistan.


In terms of production capacity construction, AIM Vaccine has also made preparations in advance for the overseas launch of new products. The company stated, "The GMP workshops for the iterative pneumonia series vaccine and the iterative rabies series vaccine have been completed, all meeting international standards".


According to data from www.icandata.com, it is expected that the global vaccine market size will reach 83.1 billion US dollars in 2025, among which the Chinese vaccine market size will exceed 200 billion yuan. AIM Vaccine, which is in the golden track, is accelerating with innovative strength, and the performance inflection point is arriving.