Finance.china.com.cn March 28  Domestic vaccine leader company Amy Vaccine today released the 2023 performance announcement and several blockbuster vaccine R&D progress announcements. According to the announcement, the company continues to maintain rapid growth in R&D investment, with R&D expenses exceeding 636 million yuan in 2023, a year-on-year increase of 27.2%. With the application for market launch of 3 blockbuster vaccines this year and the application for clinical trials of 7 vaccines this year, Amy Vaccine's blockbuster single-item vaccines are ushering in a harvest period.

At the same time, the company's quadrivalent MDCK cell influenza vaccine has submitted a pre-application for clinical trials, and currently, all influenza vaccines launched in the country are produced based on chicken embryo technology, and there are no influenza vaccines approved for market launch based on cell substrates.

According to the announcement, the characteristics of this quadrivalent MDCK influenza vaccine are mainly reflected in the following aspects: On the one hand, currently, all influenza vaccines launched in the country are produced based on chicken embryo technology, and there are no influenza vaccines approved for market launch based on cell substrates. 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. In addition, the virus mutation rate is low during passage, it does not contain ovalbumin, and the risk of allergy is significantly reduced.

Looking at the annual report, Amy Vaccine has entered a year of harvest for iterative blockbuster vaccines. By the end of 2023, the company had obtained 14 clinical permits and carried out 21 clinical trials, among which 5 were in the final stage of Phase III clinical trials. The production workshops for these 5 Phase III clinical vaccine products have been basically completed, and various pre-market preparations are underway. So far, the 13-valent pneumococcal conjugate vaccine has completed Phase III clinical trials and has submitted the pre-examination materials for market application to the National Medical Products Administration; the 23-valent pneumococcal polysaccharide vaccine and serum-free iterative rabies vaccine Phase III clinical trials have completed the full course of vaccination for subjects; the world's first innovative vaccine EV71-CA16 bivalent hand-foot-mouth disease vaccine (human diploid cell) has obtained a clinical permit; the mRNA iterative rabies vaccine is the first non-COVID mRNA vaccine product accepted domestically.

Not only that, but the company has also made breakthrough progress in the field of combined and multivalent vaccines, which represents the future development trend of vaccines. Announcements since early March show that the company's adsorbed tetanus vaccine and Hib vaccine have both submitted pre-applications for clinical trials. Based on this, the company is actively promoting the R&D of adsorbed acellular pertussis-diphtheria-tetanus-Haemophilus influenzae type b (HIB) combined and multivalent vaccines, and it is expected that from 2024 onwards, clinical trial applications for each component vaccine and its combined and multivalent vaccines will be submitted successively.

It is worth mentioning that Amy Vaccine has 3 blockbuster iterative innovative single-item vaccines applying for market launch this year, which is expected to bring strong performance growth to the company. Taking the 13-valent pneumococcal conjugate vaccine as an example, industry consultant China Insights Consultancy (CIC) estimates that the market size in China is expected to exceed 20 billion yuan by 2030, with huge market potential. In addition, the penetration rate of the 13-valent pneumococcal conjugate vaccine in the approved age group in China is estimated to be 25.9%, while the corresponding age group in the United States has a penetration rate of over 80%, and there is still a large market space after the launch of this Amy's product.

At present, there is no serum-free rabies vaccine approved and launched on the global market. This also means that this Amy's vaccine may become one of the early approved serum-free rabies vaccine, expected to fill the domestic market gap. Amy revealed on the investor open day that the price of serum-free human rabies vaccine will be higher than that of ordinary rabies vaccine and will be launched on the market as the company's high-end vaccine product. An authoritative institution predicts that the rabies vaccine market is expected to exceed 200 billion yuan by 2030.

In the mRNA technology platform, which is at the forefront of the industry in terms of technical level and R&D progress, Amy has not only laid out iterative upgrades of mRNA rabies vaccines but also global popular blockbuster new vaccines such as RSV and shingles. After Pfizer and GSK's RSV vaccines were approved and launched in May 2023, their sales in that year reached 2.46 billion US dollars, and GSK's shingles vaccine sales in 2023 were 4.37 billion US dollars. According to an article inNature Reviews: Drug Discoveryin 2021, it is estimated that the global mRNA vaccine market will reach about 23 billion US dollars around 2035. Amy Vaccine stated in the announcement that, given that several mRNA COVID-19 vaccines have been developed and clinically tested, the company can quickly promote the R&D and registration of mRNA products on this basis.

It is worth noting that in the field of vaccine innovation and R&D, Amy is using AI for the design of vaccine antigen structures and mRNA sequences, 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.

Production and sales strength support the good expectation of Amy's performance growth. According to the announcement, Amy Vaccine is a very rare comprehensive vaccine industry group with advantages in four dimensions: pipeline, R&D, production, and sales. The well-known "old brand" products such as Hansen yeast recombinant hepatitis B vaccine and Vero cell freeze-dried human rabies vaccine have always occupied a leading position in the market and have always maintained a 100% pass rate in the batch release of the National Institutes for Food and Drug Control since their launch. Sales cover all 31 provinces, cities, and autonomous regions in China, reaching more than 2,000 district and county disease control centers. Over the years, Amy's sales ability has withstood market tests. Therefore, industry insiders said that there is every reason to believe that Amy's continued high R&D investment will soon bear fruit and achieve a significant increase in sales revenue. According to public information, it is expected that the Chinese vaccine market will further increase to 215.7 billion yuan (excluding COVID-19 vaccines) by 2030, significantly faster than the global market. From the perspective of the company's development strategy, Amy will not only be based in China in the future but also make great strides in the overseas market.

According to the announcement, in order to speed up the international business, Amy has set up an international business department to accelerate the implementation of a series of international layouts, and has made comprehensive preparations in overseas market listings, product R&D, production, and other aspects, and the company's vaccine products have opened the door to the global market.

At present, the company has several clear overseas markets and has started the registration work of launched products in Southeast Asia, Africa, South America, the Middle East, and other regions. The company's rabies vaccine has obtained registration permits from countries such as Pakistan. There are R&D products such as the 13-valent pneumococcal conjugate vaccine, quadrivalent meningococcal conjugate vaccine, respiratory syncytial virus vaccine, and shingles vaccine, etc. The company is working hard to promote the launching registration and sales of these products both domestically and internationally, and to achieve pre-qualification of vaccines by the World Health Organization. With the huge demand in domestic and international markets, as the blockbuster iterative new products are launched one after another, the vaccine leader Amy will usher in a period of rapid growth in performance.