Founded in 2015, we are a China-based vaccine company dedicated to the research, development, manufacturing and commercialization of innovative vaccines* and traditional vaccines adopting new technical methods. As of the Latest Practicable Date, we had (i) two Core Products, the quadrivalent subunit influenza vaccine, which was approved by the National Medical Products Administration of the PRC (NMPA) for individuals aged three years and above under the brand name Huierkangxin (慧爾康欣) in May 2023, and lyophilized (freeze-dried) human rabies vaccine candidate, which is developed using human diploid cells with robust safety profile; and (ii) 11 other vaccine candidates covering various disease areas with considerable needs for vaccination.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET ALL OF OUR CORE PRODUCTS AND OTHER PIPELINE PRODUCTS SUCCESSFULLY.
OUR CORE PRODUCTS
Quadrivalent Subunit Influenza Vaccine Our quadrivalent subunit influenza vaccine is designed to offer broad protection against two influenza A viruses (H1N1 and H3N2 subtypes) and two influenza B viruses (Yamagata and Victoria lineages). Compared to whole-pathogen or split-virion vaccines, subunit influenza vaccines contain only crucial components of the viruses and require further purification after viral split, thus facilitating precise antigen targeting and ensuring a better safety profile with lower risks of adverse reactions. As a result, subunit influenza vaccines, including our quadrivalent subunit influenza vaccine, are typically priced at a premium relative to whole-pathogen and split-virion vaccines. We completed a Phase III clinical trial in healthy participants aged 3 years or above in China in December 2021. In this trial, in the total population of participants aged three years and above, our quadrivalent subunit influenza vaccine demonstrated better* or non-inferior** safety and efficacy for all four virus strains compared to the control quadrivalent split-virion influenza vaccine. In the same group of participants, our quadrivalent subunit influenza vaccine achieved seroprotection rates above the widely used European Union standard of 70.0%.
Our quadrivalent subunit influenza vaccine received NDA approval from the NMPA in May 2023 for use in individuals aged three years and above under the brand name Huierkangxin (慧爾康欣). It was the first and only quadrivalent subunit influenza vaccine approved in China as of the Latest Practicable Date. Employing our in-house manufacturing facilities and sales and marketing team, we commenced commercialization of this vaccine in September 2023 after receiving approval and generated revenue of RMB52.2 million, RMB259.6 million and RMB0.4 million in 2023, 2024 and the three months ended March 31, 2025, respectively. During the Track Record Period and up to the Latest Practicable Date, we manufactured all of our quadrivalent subunit influenza vaccine products in-house. As of the Latest Practicable Date, we were developing the quadrivalent subunit influenza vaccine for the 6 to 35 months age group. We had completed a Phase III clinical trial in healthy participants aged 6-35 months in China in April 2024 and had submitted an NDA for this age group, which was accepted by the NMPA in June 2024. We do not expect any material impediment in obtaining the NDA approval for such age group and expect to receive the approval in the third quarter of 2025. According to Frost & Sullivan, such approval timeline is in line with industry norm. As of the same date, we were also developing (i) an adjuvanted version of the vaccine for individuals aged 65 and above; (ii) a trivalent subunit influenza vaccine for individuals aged three years and above and aged 6 to 35 months; and (iii) an adjuvanted trivalent subunit influenza vaccine for individuals aged 65 and above. Upon approval of such vaccines, we expect to achieve a subunit influenza vaccine franchise that features full age- and valent-range coverage.
Addressable Market and Competitive Landscape
China’s influenza vaccine market is large but remains significantly underpenetrated. According to the China CDC, the overall influenza vaccination rate in China was 3.8% in the 2022-2023 flu season, which dwarfed in comparison to developed markets such as the U.S., where the vaccination rate was 49.3% in all people aged six months and older for the same flu season, according to the U.S. CDC. According to Frost & Sullivan, the influenza vaccine market in China grew significantly from RMB2.0 billion in 2019 to RMB7.0 billion in 2024, at a CAGR of 28.7%, despite a decrease in market size in 2024 primarily due to the drop in the average prices of trivalent and quadrivalent inactivated influenza vaccines. The total number of lot release of influenza vaccines increased from 30.8 million in 2019 to 75.4 million in 2024. The influenza vaccine market in China is expected to further increase to RMB20.5 billion in 2033. As the first quadrivalent subunit influenza vaccine, developed by us, was approved by the NMPA in May 2023, the subunit influenza vaccine market in China is estimated to grow rapidly from RMB0.7 billion in 2024 to RMB2.9 billion in 2033, at a CAGR of 18.0%.
China’s influenza vaccine market is highly competitive and we may incur increased costs to broaden the market acceptance considering that our quadrivalent subunit influenza vaccine was the first and only approved quadrivalent subunit influenza vaccine in China as of the Latest Practicable Date and is more expensive than other types of influenza vaccines, according to Frost & Sullivan. As of the Latest Practicable Date, all approved influenza vaccines in China were trivalent or quadrivalent influenza vaccines. According to Frost & Sullivan, in 2024, quadrivalent influenza vaccines represented 71.4% of the total influenza vaccine market in terms of production value, which is expected to decrease to about 61.5% by 2033, primarily driven by an expected increase in production value and market share of trivalent influenza vaccines based on recent WHO recommendation. WHO’s recommendation of influenza vaccine composition changes depending on the prevailing virus strains. It first recommended switching from trivalent influenza vaccines to quadrivalent influenza vaccines for the 2013-2014 flu season due to the co-circulation of two distinct B-lineages (Victoria and Yamagata). Quadrivalent influenza vaccines were introduced to address the reduced effectiveness of trivalent influenza vaccines in years when the B-lineage included in the vaccine did not match the circulating strains, particularly causing greater risks to children.
Recently, with Yamagata strains becoming rare after 2019, WHO has suggested that a return to trivalent influenza vaccines may be sufficient, while continues to publish the virus strain composition for quadrivalent influenza vaccine where such vaccines are still in use due to their comprehensive protection. We do not believe that WHO’s recent recommendation will negatively impact the business potential of our quadrivalent subunit influenza vaccine or its strategy, as it provides broader coverage and aligns with consumer demand for high-quality vaccines that could offer comprehensive protection. See “Business—Our Product and Product Candidates—Our Core Products—Quadrivalent Subunit Influenza Vaccine—Market Opportunity and Competition” for detail.
According to Frost & Sullivan, as of the Latest Practicable Date, there were 26 marketed influenza vaccines in China, primarily including 13 trivalent vaccines (including 11 split-virion vaccines, 1 subunit vaccine and 1 live attenuated vaccine) and 12 quadrivalent vaccines (including 11 split-virion vaccines and 1 subunit vaccine (developed by us)). As of the same date, there were 19 influenza vaccine candidates under clinical development in China, including 6 trivalent vaccines (including 4 split-virion vaccines, 1 live attenuated vaccine and 1 subunit vaccine (developed by us)) and 13 quadrivalent vaccines (including 11 split-virion vaccines and 2 subunit vaccines). See “Industry Overview—Influenza Vaccines—Competitive Landscape of Influenza Vaccines in China” for details.
Lyophilized Human Rabies Vaccine (Human Diploid Cell)
The lyophilized human rabies vaccine (human diploid cell) candidate is designed for prevention against rabies, which can be prevented with proper vaccination immediately after exposure to the virus but is almost always fatal once symptoms show. According to the UK Department of Public Health, regions across Asia, including China, are classified as high-risk regions for rabies exposure from land-based animals.
Our rabies vaccine candidate is developed based on human diploid cells, which are recommended by the WHO as one of the safest cell culture substrates for the production of viral vaccines. Our rabies vaccine candidate demonstrated a promising safety profile in its completed Phase I clinical trial. We are developing the rabies vaccine candidate for three immunization regimens: Essen (five doses), Zagreb (four doses) and simplified four-dose. We completed a Phase I clinical trial of the candidate in October 2024 and plan to commence a Phase III clinical trial in the third quarter of 2025.
Addressable Market and Competitive Landscape
According to Frost & Sullivan, the human rabies vaccine market in China, in terms of production value, increased from RMB3.8 billion in 2019 to RMB9.5 billion in 2024, at a CAGR of 20.3%. The total number of lot release increased from 58.8 million in 2019 to 77.8 million in 2024. Driven by increase in vaccination rates and the introduction of high-value rabies vaccines, the human rabies vaccine market in China is estimated to further increase to RMB13.0 billion in 2033, at a CAGR of 3.5% from 2024 to 2033. Rabies vaccines developed using human diploid cells are anticipated to partially replace traditional vaccines developed using Vero and primary hamster kidney cell. In 2024, human rabies vaccines developed using human diploid cells accounted for 24.2% of the total rabies vaccine market in terms of production value, with a projected increase to approximately 41.5% by 2033, according to Frost & Sullivan.
China’s market for human rabies vaccines is highly competitive. Various types of human rabies vaccines have been approved and compete in China’s market. According to Frost & Sullivan, as of the Latest Practicable Date, there were 23 marketed human rabies vaccines in China, including 15 vaccines developed from Vero cells, 6 vaccines developed from hamster kidney cells and 2 vaccines developed from human diploid cells. As of the same date, there were 20 human rabies vaccine candidates under clinical development in China, primarily including 12 vaccines developed from Vero cells and 6 vaccines developed from human diploid cells (including our rabies vaccine candidate). See “Industry Overview—Human Rabies Vaccines—Competitive Landscape of Human Rabies Vaccines in China” for details.
Source: Ab&B Bio-Tech-B (02627) Prospectus (IPO Date : 2025/07/31) |