Financial Services Association, January 30 (Reporter He Fan) Following the listing on the Beijing Stock Exchange on March 15 last year, today Leisure Guard (833575.BJ) announced that it has submitted a prospectus to the Hong Kong Stock Exchange.

Currently, the company has multiple vaccine pipelines, but they are all in the development stage. The fastest progressing trivalent HPV vaccine is expected to be submitted to China by the end of this year. Despite the current squeeze from imported nine-valent HPV vaccines, the volume and price of domestic low-priced “cheap” vaccines have plummeted, industry experts were still optimistic about the HPV vaccine market in an interview with a reporter from the Financial Federation. They believe that there is room for the trivalent HPV vaccine. However, with regard to the likely competitive situation in the nine-valent HPV vaccine market, companies need to do differentiated research and development and upgrade and iterate products.

Submitted to the Hong Kong Stock Exchange after less than a year

Following the previous announcement that it would go public in Hong Kong, today the Beijing Stock Exchange's “First Stock for Human Vaccine” morning trading announcement was officially submitted to the Hong Kong Stock Exchange. On January 29, an application was submitted to the Hong Kong Stock Exchange to issue overseas listed foreign shares (H shares) and list them on the main board of the Hong Kong Stock Exchange.

If all goes well, Recreation Guard is expected to become the first “North+H” listed company.

Health Guard is a biomedical company with structure-based antigen design as its core technology. It is mainly engaged in research, development and industrialization of recombinant protein vaccines. According to the company's application data, the company has 10 recombinant human vaccine R&D pipelines, including trivalent, nine-valent, and 15-valent HPV vaccines, bivalent RSV vaccine, shingles vaccine, seven-valent norovirus vaccine, quadrivalent HFMD vaccine, polio vaccine, and 1 mRNA vaccine research and development pipeline — bivalent therapeutic HPV vaccine.

It is worth noting that up to now, the company's vaccine products are all in the research and development stage, and no vaccine products have been marketed for sale. According to the company's three-quarter report, the company's revenue was 1.6011 million yuan, an increase of 80.33% over the same period in 2022, mainly due to an increase in sales of test reagents for scientific research.

Leisure Guardian told the Financial Federation reporter that the current listing in Hong Kong is an important part of the company's international layout. Using the Beijing and Hong Kong markets, it can continue to promote clinical trials, production capacity construction, and commercialization of the HPV vaccine combination that the company is developing.

According to the announcement, the funds raised by Leisure Guard will be used for clinical trials and approval of the company's core products, research and development of various pre-clinical projects, pre-production preparations and production process upgrades at the Kunming industrial base, improvement of commercial networks, international clinical and localized production, international market expansion, operating capital and other general corporate purposes.

Industry expert Li Changcheng said in an interview with a reporter from the Financial Federation that biological research and development, such as vaccine research and development, takes time, costs a lot of money, and there are many uncertainties about efficacy and safety. In addition, previous COVID-19 vaccine development may have affected the performance of Leisure Guard to a certain extent, and the company chose to go public in Hong Kong to broaden financing channels and raise more capital to meet R&D needs.

The domestic HPV vaccine market is still promising

A Financial Services Association reporter noticed that the pipeline receiving the most attention from the market focuses on the HPV vaccine field, including the trivalent HPV vaccine and the nine valent HPV vaccine male indications and female indications.

According to the company's Hong Kong stock application data, the trivalent HPV vaccine is currently progressing the trivalent HPV vaccine. It is expected that the BLA will be submitted in China before the end of this year. Compared with the existing bivalent and quadrivalent HPV vaccines, the trivalent HPV vaccine can increase the prevention rate of cervical cancer among East Asian women from 70% to 78%.

Furthermore, in the January 22 investor relations activity record, the company stated that the future market price of the trivalent HPV vaccine is expected to be higher than the commercially available bivalent HPV vaccine and lower than the commercially available quadrivalent HPV vaccine.

As domestic demand for HPV vaccines continues to grow, competition is becoming more intense. Due to factors such as the age expansion of the nine-valent cervical cancer vaccine and market competition, the volume and price of the domestically produced low-cost HPV vaccine have plummeted. As can be seen from the 2023 performance forecasts released earlier, the performance of Wantai Biotech (603392.SH) and Watson Biotech (300142.SZ) all declined to varying degrees.

Li Changcheng, on the other hand, showed an optimistic attitude towards Recreation Guard's research pipeline, believing that the HPV market in China has always been quite hot, and that the basic three-price price is still very marketable. At the same time, HPV vaccine development has passed the test of time. The maturity is relatively high, and the success rate should be high.

According to Frost & Sullivan's analysis, China's HPV vaccine market is expected to grow at a compound growth rate of 8.6% from 2022 to 2031, and grow to 73 billion yuan by 2031.

Currently, when the bivalent HPV vaccine is in recession, the domestically produced nine-valent HPV vaccine has become a must for many companies. The nine-valent HPV vaccines such as Wantai Biotech, Watson Biotech, Bowei Biotech, and Recobiology (02179.HK) have all entered phase III clinical research. Who will become the “first domestic nine-valent share” has attracted market attention.

According to reports, the 9-valent HPV vaccine currently being developed by Leisure Guard is expected to be submitted simultaneously in China and Indonesia for BLA in 2025. The nine-valent vaccine is also the first domestically produced nine-valent HPV vaccine to conduct clinical trials for male indications in China. It is expected that BLA will be submitted in China in 2027.

Leisure Guardian told the Financial Federation reporter that according to the “Technical Guidelines for Clinical Trials of Human Papillomavirus Vaccine (Trial)” issued by the Drug Review Center, if the company's trivalent HPV vaccine is successfully marketed, the nine-valent HPV vaccine may be approved at an accelerated pace.

According to Li Changcheng's analysis, the research and development of the nine-valent HPV vaccine for male indications is, on the one hand, companies compete to differentiate themselves; on the other hand, the variation of various viruses and the frequency and complexity of human interactions are increasing along with increasing health awareness, market demand is constantly increasing.

However, in response to the likely competitive situation in the nine-valent HPV vaccine market in the future, Li Changcheng said that most of the people taking the HPV vaccine now are young people. They have more and more faith in domestic scientific research capabilities and quality control, so the domestic vaccine market will get better and better. Moreover, domestically produced vaccines are still seizing markets in foreign developing countries, so even if competition is fierce, they are still optimistic about this market. At the same time, this also requires domestic companies to upgrade and iterate products. Now, in addition to products designated by the government, some promotion models similar to clinical drugs have also begun to appear in the vaccine market.