Amy Vaccine (06660.HK) released its 2023 performance on March 28. In 2023, the company's R&D expenses exceeded 636 million yuan, a year-on-year increase of 27.2%. The accumulation in the early stage is gradually reaping rewards. In 2024, it is a "big year" for Amy Vaccine's product application, with an expected 3 blockbuster vaccines applying for market launch and 7 vaccines applying for clinical trials; Amy Vaccine has completed the iterative upgrade product layout of several major series of vaccines such as pneumonia and rabies, and all pipelines are fully promoting rapid progress; supported by the mRNA technology platform proven for safety and efficacy, Amy Vaccine has developed global blockbuster single-item vaccines such as rabies, RSV, and shingles vaccines, etc.
 
In 2024, Amy Vaccine will fully exert itself, with R&D of innovative products as the leader, and strengthen the advantages of the scarce vaccine group, which is fully leading in the four dimensions of the pipeline, R&D, production, and sales.

Three Blockbuster Single-Item Vaccines are Expected to be Filed for Market Launch This Year
 
In recent years, with the increasing strength of innovative vaccine R&D, the improvement of life expectancy and the proportion of aging population, the continuous enhancement of Chinese residents' awareness of vaccine prevention and vaccination, and the increase in per capita income, China's vaccine industry will enter a stage of sustained and rapid growth.

As a leading enterprise in China's vaccine industry, Amy Vaccine has formed a R&D pipeline layout that coincides with national policies, and the R&D and market launch of related vaccine products are rapidly advancing.

The annual report shows that by the end of 2023, Amy Vaccine had obtained 14 clinical permits and conducted 21 clinical trials, among which 5 were in the final stage of Phase III clinical trials, and various pre-market preparations were underway.

It is expected that in 2024, three blockbuster iterative and upgraded products will complete the filing for market launch. Among them, the 13-valent pneumococcal conjugate vaccine (PCV13) has completed the full course of Phase III clinical immunization and has submitted a pre-application for market registration to the National Medical Products Administration; the serum-free iterative rabies vaccine and the 23-valent pneumococcal polysaccharide vaccine (PPSV23) Phase III clinical trials have completed the full course of vaccination for subjects and are about to enter the statistical unblinding work.

As a large full-industry-chain vaccine enterprise in China, Amy Vaccine covers the entire value chain from R&D to manufacturing and then to commercialization, possessing five proven human vaccine technology platforms, such as mRNA, covering the main vaccine technology routes encouraged by the state for development.

 
At present, Amy Vaccine has 8 commercialized vaccine products targeting six disease areas, being the world's largest manufacturer of hepatitis B vaccines and the second-largest manufacturer of rabies vaccines globally; it has 21 vaccines under research and development targeting fourteen disease areas, covering the top ten global vaccine varieties.

 
With the successive market launch of several blockbuster single-item vaccines in 2024, Amy Vaccine's leading position in the Chinese market will be further consolidated.

High-Level R&D Gives Birth to Iterative and Upgraded Products, Leading the Two Golden Tracks of Pneumonia and Rabies

At present, China's vaccine industry has entered a new stage of development in terms of vaccine technology iteration and upgrading, new product R&D, and the expansion of the adult market.

 
As an innovation-driven vaccine enterprise, Amy Vaccine faces new opportunities and quickly completes the layout of iterative and upgraded pneumonia and rabies vaccines with strong innovation capabilities, leading the two golden tracks.

Pneumonia vaccines, as a billion-dollar major variety, have proven their commercial value through the market. Amy Vaccine has independently developed four iterative pneumonia vaccines using the advantages of the polysaccharide conjugate vaccine technology platform.

 
Among them, the 13-valent pneumococcal conjugate vaccine has completed the on-site work of Phase III clinical trials and has submitted a pre-application for market launch registration; the 23-valent pneumococcal polysaccharide vaccine has also completed Phase III clinical trials and is expected to submit a market launch registration application in 2024; the 20-valent pneumococcal conjugate vaccine has submitted a clinical trial pre-application; the globally synchronized first researched 24-valent pneumococcal conjugate vaccine will submit a clinical trial application (CTA) in 2025.

As the global vaccine sales champion for a decade, there is a huge demand gap for pneumonia vaccines. It is estimated that the global gap for the 13-valent pneumococcal conjugate vaccine is as high as 180 million doses per year. Currently, only three companies worldwide are approved to supply, and Amy Vaccine, as the only company that simultaneously layouts 13-valent, 20-valent, and 24-valent pneumococcal conjugate vaccines, is expected to welcome an explosive cash flow growth as the products are launched successively.

The company stated, "After the above iterative pneumonia vaccine series are launched, they will be able to fully meet the market demand for pneumonia vaccines, achieve new quality production forces in the industry, and lead international industry innovation."

As the world's second-largest supplier of rabies vaccines, Amy Vaccine leads the in-depth technical iteration and upgrading of global rabies vaccines and rapidly promotes the launch process of new products.

Among them, the on-site work of the Phase III clinical trials for the serum-free iterative rabies vaccine has been completed, and various preparations before the new drug application for market launch are underway, with plans to submit a market launch registration application in 2024; the novel process high-efficacy human diploid cell rabies vaccine has submitted a clinical trial pre-application; the mRNA iterative rabies vaccine is the first non-COVID mRNA vaccine product accepted domestically.

Regarding the future strategic layout arrangements for rabies vaccines, according to the company's performance conference, the novel process high-efficacy human diploid cell rabies vaccine will be positioned differently in the market from the serum-free rabies vaccine, replacing the original channel vero cell rabies vaccine products.

China is the world's largest market for rabies vaccines. Data shows that from 2015 to 2020, an average of about 70 million doses of human rabies vaccines were needed per year, and it is expected that from 2021 to 2030, this number will increase to 80 million doses.

 
As a leading enterprise in the domestic rabies vaccine market share, Amy Vaccine has unique technical advantages and forward-looking production capacity construction. With the introduction of a series of upgraded rabies vaccines, Amy Vaccine will provide the market with products of better quality, higher safety, and fewer vaccination doses, expanding the company's competitive advantage in the rabies vaccine market.

 
Through new product iteration, Amy Vaccine actively embraces new opportunities for technical upgrades and layouts for several globally innovative products, including three globally synchronized first researched innovative vaccines: EV71-CA16 bivalent hand-foot-mouth disease vaccine, 24-valent pneumococcal conjugate vaccine, and mRNA iterative rabies vaccine. This not only shows the technical strength of Amy Vaccine, but also reflects China's independent innovation capabilities in the vaccine field.

According to the annual report, in 2023, Amy Vaccine's R&D expenses exceeded 636 million yuan, a year-on-year increase of 27.2%, with R&D revenue accounting for 53.6%, far exceeding the industry average, providing strong support for the launch of new products.

mRNA Technology Platform Powers Globally Popular Blockbuster Single-Item Vaccines

mRNA vaccines have been vaccinated billions of doses worldwide, shining in the prevention and control of the COVID-19 epidemic, and subsequently, mRNA technology won the Nobel Prize, attracting even more global attention. Against this backdrop, mRNA technology has become a focus for major global vaccine manufacturers for the future.

Amy Vaccine has an independently innovated mRNA technology platform, which has been verified by clinical trial data from tens of thousands of subjects. From pre-clinical trial data, the effectiveness of Amy's mRNA rabies vaccine and mRNA shingles vaccine is much higher than that of similar products on other technical routes, with a very obvious advantage.

At present, the mRNA iterative rabies vaccine is the first non-COVID mRNA vaccine accepted by the Center for Drug Evaluation, NMPA, which has significant advantages compared to traditional rabies vaccines cultured through virus cultivation; the RSV vaccine and shingles vaccine developed by the company on this technical platform will both submit clinical trial applications (CTA) in 2024.

Looking at the sales situation of competitive products already on the market, the mRNA RSV vaccine and mRNA shingles vaccine being developed by Amy Vaccine are both global blockbuster vaccines. Pfizer and GSK's RSV vaccines were approved and launched in May 2023, with sales of $2.46 billion in 2023, and GSK's shingles vaccine had sales of $4.37 billion in 2023. The launch of these two major single-item vaccines by Amy Vaccine in the future will become a breakout point for the company's performance growth

Currently, major companies around the world are laying out mRNA technology, and as more products are successfully developed and implemented, the mRNA vaccine market will grow rapidly, with broad market prospects.

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

Industry insiders analyzed and pointed out that Amy Vaccine has been actively promoting the development of its vaccine product pipeline according to the established company strategy, and in 2024, it will enter a concentrated harvest period for R&D products. With the launch of several blockbuster single-item vaccines, the company is expected to usher in rapid growth.