Another domestic 13-valent pneumococcal polysaccharide conjugate vaccine (hereinafter “PCV13”) has entered Phase III clinical trials. It is learned that this vaccine is a major vaccine product across the globe, which is only supplied by Pfizer, Walvax and BIOKANGTAI and in great demand. With this new product entering the final stage of clinical research, more stories are going to be written in the market.

 

On the October 14th, the Ethics Committee for Vaccine Clinical Trials of the Yunnan Provincial Center for Disease Prevention and Control issued an ethical approval for Phase III clinical trials of this vaccine, marking the beginning of its Phase III clinical trials. According to public data, this vaccine is independently researched and developed by AIM Vaccine Co., Ltd.

 

At present, AIM Vaccine has already submitted its IPO prospectus to the HKSE.

 

PCV13 in great demand and short supply

 

PCV13 is suitable for preventing pneumococcus-caused diseases in infants. Infectious diseases caused by pneumococcus is the primary reason for vaccine-preventable death of children under 5 years of age globally. The immune system of children in this age group is still developing, and simple polysaccharide vaccine cannot stimulate the body to produce enough antibodies.

 

Therefore, a vaccine capable of polysaccharide-protein conjugation is an inflexible demand, and products of this kind are in huge demand. According to the research report released by Zhongtai Securities this August 29, the global sales of Pfizer’s PCV13 reached 5.85 billion US dollars in 2020; with the improvement of affordability and immunization coverage rate, the domestic market size of PCV13 is likely to reach 10.8 billion yuan.

 

On the other hand, the supply of PCV13 still falls short of demand in China. At present, only Pfizer, Walvax and BIOKANGTAI have obtained approval for their PCV13 products to enter the market, forming a good competitive landscape. After analyzing the supply and demand of PCV13 in the first three quarters of 2020, LeadLeo Research Institute concluded that the lot release amount of PCV13 is only enough for vaccinating around 1.6 million infants, which is far from full satisfaction of the market demand.

 

As for enterprises in the course of research, Lanzhou Institute and CanSinoBIo are carrying out Phase III clinical trials.

 

As disclosed by the prospectus of AIM Vaccine, it is planning to enroll about 3000 subjects for Phase III clinical trials. If everything goes well, it will submit new drug application to the National Medical Products Administration in 2023, and commercialize its new vaccine in 2024.

 

Obvious advantages in commercialization

 

Compared to the aforementioned enterprises, the advantages of AIM Vaccine lie in whole industry chain and big platform, which enable it to realize large-scale production capacity release and guarantee market supply upon obtaining approval for the market.

 

It is reported that AIM Vacin, a wholly-owned subsidiary of AIM Vaccine, has already completed reconstruction and upgrade of its pneumococcal vaccine production line, which can realize large-scale market supply of high-quality vaccines with a designed annual production capacity of 47 million doses.

 

As for the product itself, AIM Vaccine believes that the continuation of its technological superiority in the core technology of PCV13 can guarantee the effect of vaccination to a certain extent. According to data derived from the animal test of AIM Vaccine’s PCV13, in a comparison of antibody level of 13 serotypes, its PCV13 has 10 serotypes which demonstrate better immunogenicity than imported vaccines.

 

Also, being China’s No.1 private-owned vaccine industrial group (based on the lot release amount in 2020), AIM Vaccine has substantial sales strength. Up to now, AIM Vaccine has deployed a sales team of more than 100 members to effectively cover the downstream customer market of vaccine, i.e. centers for disease control and prevention. In its prospectus, AIM Vaccine expressed, “We have stable relationships with five major clients, with an average cooperation time of 13 years.”

 

In addition to PCV13, the reported also noticed many other promising products of AIM Vaccine under development. For example, the ACYW135 meningococcus polysaccharide vaccine’s clinical trial application has been accepted by the CDE, and the Phase I clinical trials of its mRNA COVID-19 vaccine are being carried out orderly.

 

From the aspect of core technology platform, AIM Vaccine is the only Chinese vaccine enterprise owning all five verified human vaccine platform technologies throughout the world, i.e., bacterial vaccine platform technology, viral vaccine platform technology, genetic engineering vaccine platform technology, combined vaccine platform technology and mRNA vaccine platform technology, with product layout under each of the platform technologies.

 

It is foreseeable that, with the upgrade of vaccine technologies, the increase of domestic demand for disease prevention and control, as well as the continuous advancement of the enterprise upon listing and completion of financing, AIM Vaccine will grow into a giant vaccine conglomerate under the comprehensive platform layout.

 

From 2018 to 2020, AIM Vaccine has achieved a revenue of 1.111 billion yuan, 952 million yuan and 1.638 billion yuan respectively, a gross margin of 866 million yuan, 733 million yuan and 1.354 billion yuan respectively, and a profit of 101 million yuan, 120 million yuan and 400 million yuan respectively, with a compound annual growth rate of 98.7%. It is one of the domestic vaccine enterprises with the highest profit growth rate.

(Reported by: Reported Jin Xiaomo of Cailian Press)