Vaccine leader Amy Vaccine today submitted its 2023 performance report card. By the end of 2023, it had obtained 14 clinical permits and carried out 21 clinical trials, with 5 in the final stage of Phase III clinical trials. The 13-valent pneumococcal conjugate vaccine, serum-free iterative rabies vaccine, and 23-valent pneumococcal polysaccharide vaccine, three blockbuster iterative upgrade products, are expected to apply for market launch within 2024, and another 7 blockbuster iterative upgrade vaccines will apply for clinical trials this year.

During the reporting period, affected by the changes in the COVID-19 pandemic, the company provided for impairment of intangible assets and goodwill, leading to a loss in performance. R&D expenses continued to grow rapidly, with R&D expenses exceeding 636 million yuan in 2023, a year-on-year increase of 27.2%. From a revenue perspective, Amy's performance in 2023 was not particularly outstanding. However, comparing the experience of the development of international vaccine giants, vaccines often have a life cycle. How enterprises can adjust their direction in time and whether there are other varieties reserved afterwards is the key to winning. Amy Vaccine, which highly values R&D and innovation, has strong upward momentum when several blockbuster iterative vaccines are at the critical point of commercialization.

Passion for mRNA Remains Undiminished, Insisting on Doing Difficult But Correct Things

In the vaccine race, with the successful promotion of mRNA COVID-19 vaccines, mRNA (messenger ribonucleic acid) technology has gained unprecedented attention and has won the favor of the capital market. Nowadays, many people are asking, after the craze has subsided, how much market prospect does mRNA still have? The answer is affirmative. The application of mRNA technology, which has been endorsed by the Nobel Prize, is still a blue ocean.

Data indicates that from 2023 to 2028, the market size of mRNA vaccines and therapies will grow rapidly at a compound annual growth rate of 16.8%, and it is expected to reach 101.8 billion US dollars in 2028. Amy, which has taken the lead in deploying the mRNA technology platform in China and is at the forefront in clinical and industrialization aspects, undoubtedly believes in the potential of this technology platform and continues to work hard for it.

According to the annual report, in terms of the layout of the mRNA technology platform, Amy Vaccine has deployed several blockbuster products on this platform, and the safety and efficacy of the platform's products have been fully verified through clinical trial data of tens of thousands of subjects. The company has developed an mRNA iterative rabies vaccine on this platform, which, compared with the traditional rabies vaccine cultured through viruses, has significantly fewer immunization injections, higher protective neutralizing antibodies, and significantly faster production speed, strong immune persistence, and other characteristics, providing a better choice for effectively preventing rabies. At the same time, the company's RSV vaccine and shingles vaccine based on this platform are expected to complete clinical trial applications in 2024.

The company will further focus on the key technologies of the mRNA platform in the future, continue to promote product innovation on this basis, focus on the unmet clinical needs in core disease areas, and further enhance the company's innovation capabilities, core competitiveness, and comprehensive strength.

Iterative Upgrade of Major Single-Item Layout, Leading Multiple Golden Tracks

In the R&D of blockbuster iterative vaccines, Amy has always maintained a state of urgency and has invested real money. From 2020 to 2023, the company's R&D expenditures were 158 million yuan, 307 million yuan, 500 million yuan, and 636 million yuan respectively, with a compound annual growth rate of 59.1%. In 2023, R&D revenue accounted for 53.6%, ranking at the forefront of the industry.

The blockbuster single-item vaccines developed by the company are veritable iterative upgraded vaccines. Just on the 28th, Amy Vaccine announced that its quadrivalent MDCK cell influenza virus vaccine has submitted a clinical pre-application. According to the announcement, the influenza vaccines currently on the domestic market are all produced based on chicken embryo technology, and there are no influenza vaccines based on cell substrates that have been approved for market launch. More importantly, due to the high variability of the influenza virus, Amy uses MDCK cells instead of chicken embryos for cultivation, which have a shorter production cycle, do not have the problem of unstable raw material supply, have strong ability to cope with virus mutations, can be automatically and scaled-up cultivated in bioreactors, have low contamination risk, are easy to scale up for industrial production, and therefore can produce products to deal with seasonal epidemic strains according to the seasonal candidate strains announced by WHO, better meeting public health needs. Industry consultant China Insights Consultancy (CIC) estimates that the Chinese influenza vaccine market size will be about 20 billion yuan in 2030.

As the world's second-largest rabies vaccine company, Amy's product layout of iterative upgraded rabies vaccine is unique in the industry. Amy's serum-free iterative rabies vaccine is about to enter the statistical unblinding work; the novel process high-efficacy human diploid cell rabies vaccine has submitted a clinical trial application; the company's mRNA iterative rabies vaccine is the first non-COVID mRNA vaccine accepted by the Center for Drug Evaluation, NMPA for clinical trial application.

In addition, in the iterative upgraded pneumonia series vaccines, the 13-valent pneumococcal conjugate vaccine has submitted a pre-application for market launch and is expected to apply for registration and market launch within the year; the 23-valent pneumococcal polysaccharide vaccine is also expected to apply for registration and market launch within the year; the 20-valent pneumococcal conjugate vaccine has submitted a clinical trial pre-application; the globally synchronized first researched 24-valent pneumococcal conjugate vaccine has completed pre-clinical research work. Speaking of the 13-valent pneumococcal conjugate vaccine alone, China Insights Consultancy (CIC) estimates that the market size in China will exceed 20 billion yuan in 2030.

It is worth noting that Amy Vaccine is using AI for the design of vaccines’ antigen structure and mRNA sequence, and trying to use AI to assist in vaccine process R&D work, which is expected to increase the depth of existing applications and expand the application in clinical trial data analysis in the later stage.

Looking back at the stock price trend of Amy Vaccine since the end of last year, affected by various factors, its Hong Kong stock price has been hovering at a low level. In response, Amy Vaccine stated that it is actively analyzing the relevant factors and believes that the bearish factors of the stock price have been fully released in advance. The company has announced a share repurchase plan, and the controlling shareholder has continuously increased its holdings for several times. These measures not only demonstrate the company's confidence in its own business growth and prospects, but also help to increase the value of shares and increase shareholder returns. In the future, as several blockbuster iterative single-item vaccines enter the harvest period, the company's value and competitiveness are expected to be further significantly improved.