NEWS
Amy Vaccine has seen Multiple Iterations and Upgrades of Its Vaccines This Year, with a Concentrated Submission of Blockbuster Vaccines
Vaccine industry leader Amy Vaccine (06660.HK) has recently released several R&D progress announcements. Not only has the 13-valent pneumococcal conjugate vaccine submitted a pre-application for market registration, but also blockbuster products such as the 13-valent pneumococcal conjugate vaccine, serum-free iterative rabies vaccine, and 23-valent pneumococcal polysaccharide vaccine are planned to be completed and filed for market launch within the year. Additionally, there are blockbuster new products like the quadrivalent meningococcal conjugate vaccine and adsorbed acellular pertussis-diphtheria-tetanus-Haemophilus influenzae type b (HIB) combination vaccine that are rapidly advancing in research and development. Entering 2024, Amy Vaccine's blockbuster innovative iterative products have entered an intensive filing period, and the company is accelerating the formation of new quality production forces. According to Amy Vaccine's 2023 performance forecast, based on the premise that its sales revenue is essentially the same as in 2022, due to significant changes in the COVID-19 pandemic, the company has made substantial impairment provisions for intangible assets and goodwill related to relevant acquisitions. Coupled with the fact that five major core products are all in phase III clinical status, this has led to a significant increase in R&D expenses for the year, resulting in a forecasted loss.
Although Amy Vaccine's performance is expected to be at a loss, the performance disclosure announcement reveals another layer of positive signal—the continuous advancement of non-COVID mRNA technology product R&D, and the company is actively promoting the R&D of several significant iterative upgrade blockbuster products according to its established strategy.
Innovation-Driven, High-Level R&D Spawns Iterative Upgrade Products
For new quality production forces, innovation-driven is the key to "new". Amy Vaccine is an innovation-driven vaccine company.
In the race of rabies vaccine iterative upgrades, Amy Vaccine leads the global technological iteration and innovation. According to the company's announcement, as the world's second-largest supplier of rabies vaccines, Amy Vaccine has completed the layout of its rabies vaccine series iterative upgrades. Currently, the site work for the phase III clinical trial of 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 complete the filing and launch this year; the novel process human diploid cell rabies vaccine is expected to submit a pre-application for clinical trials in the first half of this year; the mRNA rabies vaccine is the first non-COVID mRNA vaccine product accepted domestically.
Amy Vaccine stated that after the launch of the aforementioned iterative rabies vaccine series, it will provide the market with rabies vaccine products of better quality and higher safety, effectively contributing to the development of the industry's new quality production forces.
It is worth noting that the serum-free iterative rabies vaccine, which is about to enter the harvest period, is completely different from the currently available Vero cell rabies vaccine containing serum and the human diploid cell rabies vaccine containing serum, and is an iteratively upgraded product. The residual animal serum in vaccine products is one of the important factors causing adverse reactions such as allergies in the vaccinated population. The serum-free iterative rabies vaccine developed by Amy Vaccine does not contain animal serum, significantly improving safety and reducing the probability of adverse reactions. To date, there are no serum-free rabies vaccines approved and launched on the global market, and Amy is expected to fill the market gap.
In addition, the novel process human diploid cell rabies vaccine developed by Amy has taken the lead in breaking through the traditional technical bottlenecks of low virus titer and small output in this process, and has optimized and innovated in the purification process. Compared with similar products already on the market in China, both the product quality and safety have been significantly improved, and it has the production capacity for large-scale industrialization.
At the same time, Amy's independently developed mRNA technology platform has been verified by clinical trial data from tens of thousands of subjects, and an mRNA iterative rabies vaccine has been developed on this platform. This vaccine is the first non-COVID mRNA vaccine accepted by the Center for Drug Evaluation, NMPA for clinical trial application. A large number of animal experiments have proven that compared with rabies vaccines traditionally cultured through viruses, this vaccine has significantly fewer immunization injections, significantly faster production of protective neutralizing antibodies, and significantly enhanced overall protective effects.
It is worth mentioning that in several announcements released on March 4, Amy Vaccine announced for the first time the company's layout in the field of combined vaccines. Combined and multivalent vaccines are the development trend of future vaccine products, and Amy Vaccine is actively promoting the R&D of adsorbed acellular pertussis-diphtheria-tetanus-Haemophilus influenzae type b (HIB) combination vaccine (referred to as "quadrivalent vaccine"), and is expected to submit clinical trial applications for the quadrivalent vaccine and its various component vaccines starting from 2024.
It is understood that Amy has five verified human vaccine technology platforms, covering innovative technologies such as mRNA vaccines, genetic engineering vaccines, and combined vaccine technologies, as well as classic technology platforms, bacterial vaccine and viral vaccine technology platforms. The company has 23 blockbuster products under research and development, covering 14 disease areas, with 5 blockbuster products in phase III clinical trials.
In terms of the layout of iterative upgrade innovative products, as revealed by Amy's senior management at the investor open day at the end of last year: "The company insists on being open and grand, it is an approach of opening the door and taking the main road". In the first half of 2023 alone, the company's R&D investment was nearly 400 million yuan, a year-on-year increase of 105%, and the proportion of R&D investment to sales revenue was 74%, far exceeding the industry average.
Three Blockbuster New Products are About to be Launched This Year, with Broad Market Prospects
Among the rich R&D pipeline layout of Amy Vaccine, the 13-valent pneumococcal conjugate vaccine, serum-free iterative rabies vaccine, and 23-valent pneumococcal polysaccharide vaccine are about to be launched. The company has completed the construction of production workshops for the above three vaccines and has produced phase III clinical trial samples in the completed production workshops.
Amy Vaccine stated that as these blockbuster new products are gradually launched, the company is expected to promote the development of the industry's new quality production forces and lead the two golden tracks of pneumonia vaccines and rabies vaccines.
The 13-valent pneumococcal conjugate vaccine is one of the emerging main varieties in recent years. This vaccine is mainly used for infants and children aged from 6 weeks to 5 years in China, with a low vaccination rate and extremely strong market demand. According to the annual report, Pfizer's pneumococcal conjugate vaccine had global sales of about $6.337 billion in 2022. Currently, only 3 companies worldwide have launched this product, and Amy is expected to become one of the important suppliers.
The 13-valent pneumococcal conjugate vaccine approved in the United States covers all age groups, while the one approved in China only covers those under 6 years old, leaving the market for people over 6 years old in a blank state. 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%, still with significant market space.
At the same time, Amy Vaccine's 23-valent pneumococcal polysaccharide vaccine has also completed Phase III clinical trials and is expected to apply for registration and market launch within 2024. It is understood that this product is suitable for preventing invasive pneumonia diseases in people over 2 years old (especially for the elderly over 60).
China is the world's largest market for rabies vaccines. According to data from China Insights Consultancy (CIC), the Chinese rabies vaccine market is expected to grow to 14.8 billion yuan by 2030. With the introduction of Amy Vaccine's upgraded series of rabies vaccines, it is expected to drive a significant increase in the sales amount of the rabies vaccine market.
According to Amy Vaccine's 2023 performance forecast, based on the premise that its sales revenue is essentially the same as in 2022, due to significant changes in the COVID-19 pandemic, the company has made substantial impairment provisions for intangible assets and goodwill related to relevant acquisitions. Coupled with the fact that five major core products are all in phase III clinical status, this has led to a significant increase in R&D expenses for the year, resulting in a forecasted loss.
Industry insiders analyze that despite the forecasted loss, Amy Vaccine has been actively promoting the development of its vaccine product pipeline according to its established company strategy. At the beginning of 2024, it has entered a concentrated harvest period for R&D products, with many products being concentrated for application, and with the launch of three blockbuster vaccines, it is expected to become a new growth point for the company's performance.
In addition, in the capital market, Amy Vaccine has announced share repurchase plans on multiple occasions, and the controlling shareholder has continuously increased its holdings. According to relevant persons in the company, these measures not only consolidate the foundation of the company's development but also demonstrate the company's confidence in its own business growth and prospects. With the continuous advancement of the company's iterative new products, the company's value and competitiveness will be further highlighted.
Although Amy Vaccine's performance is expected to be at a loss, the performance disclosure announcement reveals another layer of positive signal—the continuous advancement of non-COVID mRNA technology product R&D, and the company is actively promoting the R&D of several significant iterative upgrade blockbuster products according to its established strategy.
Innovation-Driven, High-Level R&D Spawns Iterative Upgrade Products
For new quality production forces, innovation-driven is the key to "new". Amy Vaccine is an innovation-driven vaccine company.
In the race of rabies vaccine iterative upgrades, Amy Vaccine leads the global technological iteration and innovation. According to the company's announcement, as the world's second-largest supplier of rabies vaccines, Amy Vaccine has completed the layout of its rabies vaccine series iterative upgrades. Currently, the site work for the phase III clinical trial of 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 complete the filing and launch this year; the novel process human diploid cell rabies vaccine is expected to submit a pre-application for clinical trials in the first half of this year; the mRNA rabies vaccine is the first non-COVID mRNA vaccine product accepted domestically.
Amy Vaccine stated that after the launch of the aforementioned iterative rabies vaccine series, it will provide the market with rabies vaccine products of better quality and higher safety, effectively contributing to the development of the industry's new quality production forces.
It is worth noting that the serum-free iterative rabies vaccine, which is about to enter the harvest period, is completely different from the currently available Vero cell rabies vaccine containing serum and the human diploid cell rabies vaccine containing serum, and is an iteratively upgraded product. The residual animal serum in vaccine products is one of the important factors causing adverse reactions such as allergies in the vaccinated population. The serum-free iterative rabies vaccine developed by Amy Vaccine does not contain animal serum, significantly improving safety and reducing the probability of adverse reactions. To date, there are no serum-free rabies vaccines approved and launched on the global market, and Amy is expected to fill the market gap.
In addition, the novel process human diploid cell rabies vaccine developed by Amy has taken the lead in breaking through the traditional technical bottlenecks of low virus titer and small output in this process, and has optimized and innovated in the purification process. Compared with similar products already on the market in China, both the product quality and safety have been significantly improved, and it has the production capacity for large-scale industrialization.
At the same time, Amy's independently developed mRNA technology platform has been verified by clinical trial data from tens of thousands of subjects, and an mRNA iterative rabies vaccine has been developed on this platform. This vaccine is the first non-COVID mRNA vaccine accepted by the Center for Drug Evaluation, NMPA for clinical trial application. A large number of animal experiments have proven that compared with rabies vaccines traditionally cultured through viruses, this vaccine has significantly fewer immunization injections, significantly faster production of protective neutralizing antibodies, and significantly enhanced overall protective effects.
It is worth mentioning that in several announcements released on March 4, Amy Vaccine announced for the first time the company's layout in the field of combined vaccines. Combined and multivalent vaccines are the development trend of future vaccine products, and Amy Vaccine is actively promoting the R&D of adsorbed acellular pertussis-diphtheria-tetanus-Haemophilus influenzae type b (HIB) combination vaccine (referred to as "quadrivalent vaccine"), and is expected to submit clinical trial applications for the quadrivalent vaccine and its various component vaccines starting from 2024.
It is understood that Amy has five verified human vaccine technology platforms, covering innovative technologies such as mRNA vaccines, genetic engineering vaccines, and combined vaccine technologies, as well as classic technology platforms, bacterial vaccine and viral vaccine technology platforms. The company has 23 blockbuster products under research and development, covering 14 disease areas, with 5 blockbuster products in phase III clinical trials.
In terms of the layout of iterative upgrade innovative products, as revealed by Amy's senior management at the investor open day at the end of last year: "The company insists on being open and grand, it is an approach of opening the door and taking the main road". In the first half of 2023 alone, the company's R&D investment was nearly 400 million yuan, a year-on-year increase of 105%, and the proportion of R&D investment to sales revenue was 74%, far exceeding the industry average.
Three Blockbuster New Products are About to be Launched This Year, with Broad Market Prospects
Among the rich R&D pipeline layout of Amy Vaccine, the 13-valent pneumococcal conjugate vaccine, serum-free iterative rabies vaccine, and 23-valent pneumococcal polysaccharide vaccine are about to be launched. The company has completed the construction of production workshops for the above three vaccines and has produced phase III clinical trial samples in the completed production workshops.
Amy Vaccine stated that as these blockbuster new products are gradually launched, the company is expected to promote the development of the industry's new quality production forces and lead the two golden tracks of pneumonia vaccines and rabies vaccines.
The 13-valent pneumococcal conjugate vaccine is one of the emerging main varieties in recent years. This vaccine is mainly used for infants and children aged from 6 weeks to 5 years in China, with a low vaccination rate and extremely strong market demand. According to the annual report, Pfizer's pneumococcal conjugate vaccine had global sales of about $6.337 billion in 2022. Currently, only 3 companies worldwide have launched this product, and Amy is expected to become one of the important suppliers.
The 13-valent pneumococcal conjugate vaccine approved in the United States covers all age groups, while the one approved in China only covers those under 6 years old, leaving the market for people over 6 years old in a blank state. 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%, still with significant market space.
At the same time, Amy Vaccine's 23-valent pneumococcal polysaccharide vaccine has also completed Phase III clinical trials and is expected to apply for registration and market launch within 2024. It is understood that this product is suitable for preventing invasive pneumonia diseases in people over 2 years old (especially for the elderly over 60).
China is the world's largest market for rabies vaccines. According to data from China Insights Consultancy (CIC), the Chinese rabies vaccine market is expected to grow to 14.8 billion yuan by 2030. With the introduction of Amy Vaccine's upgraded series of rabies vaccines, it is expected to drive a significant increase in the sales amount of the rabies vaccine market.
According to Amy Vaccine's 2023 performance forecast, based on the premise that its sales revenue is essentially the same as in 2022, due to significant changes in the COVID-19 pandemic, the company has made substantial impairment provisions for intangible assets and goodwill related to relevant acquisitions. Coupled with the fact that five major core products are all in phase III clinical status, this has led to a significant increase in R&D expenses for the year, resulting in a forecasted loss.
Industry insiders analyze that despite the forecasted loss, Amy Vaccine has been actively promoting the development of its vaccine product pipeline according to its established company strategy. At the beginning of 2024, it has entered a concentrated harvest period for R&D products, with many products being concentrated for application, and with the launch of three blockbuster vaccines, it is expected to become a new growth point for the company's performance.
In addition, in the capital market, Amy Vaccine has announced share repurchase plans on multiple occasions, and the controlling shareholder has continuously increased its holdings. According to relevant persons in the company, these measures not only consolidate the foundation of the company's development but also demonstrate the company's confidence in its own business growth and prospects. With the continuous advancement of the company's iterative new products, the company's value and competitiveness will be further highlighted.
