The Hong Kong Stock Exchange recently disclosed that Kangle Guardian has submitted the form and intends to be listed on the main board, and the joint sponsors are CITIC ** and CCB International. And the Recreation Guardian (833575BJ) has previously been listed on the Beijing Stock Exchange, which also means:Kangle Guardian is expected to become the first company to achieve "North + H" dual listing.
Compared with most of the companies that have recently submitted statements on the Hong Kong Stock Exchange, Kangle Guardian is more interesting and has attracted more investors' attention.
It has landed on the Beijing Stock Exchange, and the main HPV vaccine is available
Kangle Guardian was established in 2008 and officially listed in September 2015Since then, it has successfully landed on the Beijing Stock Exchange in March 2023It is the first stock of human vaccine on the Beijing Stock Exchange, and it is also the first innovative biomedical company to adopt the fourth set of standards to apply and successfully list since the opening of the Beijing Stock Exchange.
However, in the past year, although the Beijing Stock Exchange has been intermittently popular several times, the liquidity performance of the market is average, and the trading of many companies is relatively lightThe overall financing capacity is far inferior to that of the Shanghai-Shenzhen-Hong Kong Stock Exchange. This may also be one of the reasons for the IPO of Kangle Guardian in Hong Kong.
It is worth noting that from the first to the Beijing Stock Exchange, Kangle Guardian is also a company favored by the capital market, and the secret behind it may lie in the business that the company is engaged in.
Health Guardian is a clinical-stage vaccine developerIt has the world's broadest HPV vaccine portfolio. Among them,The core product of the trivalent HPV vaccine candidate that is close to commercializationDesigned to protect women in East Asia, the BLA is expected to be filed in China by the end of 2024. The Phase III 9-valent HPV vaccine candidate is another core productIt is expected to be one of the first domestic 9-valent HPV vaccine candidates approved for women, with a planned BLA submission in China in 2025, and is the first domestic 9-valent HPV vaccine candidate in China to begin critical efficacy trials in men. At the same time, Connaught Guardian is also conducting a phase III clinical trial in women in Indonesia, which is expected to be submitted to BPOM Indonesia in 2025.
In addition, the quasi-Phase I 15-valent HPV vaccine candidate has the highest price among all HPV vaccines that can be commercialized or have been approved by the IND in the world. Health Guard also has six preclinical vaccine candidates in development for disease areas with gaps in medical needs or in urgent need of vaccine upgrades.
As we all know, vaccines are regarded as the "best track" in the field of medicineThe HPV vaccine is the "star" of the vaccine industry and is the most valuable variety. Therefore, it is not surprising that in the first echelon of domestic HPV vaccine development, Kangle Guardian has been favored by funds.
The performance continued to lose money, significantly underperforming its peers
However, although it is deeply engaged in the "best track", the HPV vaccine of Kangle Guardian has not yet been marketed, so its performance is far from that of some peers.
The data shows that from 2020 to 2022, Kangle Guardian will achieve revenue of 8610,000 yuan (RMB, the same below). 480,000 yuan, 190060,000 yuan, and the net loss attributable to the parent company during the period was 15.2 billion yuan, 3800 million yuan, 29.3 billion yuan. In the first three quarters of 2023, Kangle Guard's revenue increased by 80% year-on-year33% to 160110,000 yuan,The net profit attributable to the parent company was 22.5 billion yuan, an increase of 6 percent year-on-year76%。
It is reported that the revenue obtained by Kangle Guardian in recent years is mainly related to the sale of detection reagents for research and development purposes. And during the periodThe loss on the profit side is due to the fact that the company has invested a lot of money in the research and development of vaccine candidates and the construction of production bases
After inquiry, in the first three quarters of 2021, 2022 and 2023,The R&D expenses of Kangle Guardian are 21.8 billion yuan, 23.7 billion yuan, 17.7 billion yuan.
It is worth mentioning that in the field of HPV vaccines, there is not only Kangle Guard, but also Zhifei Biotech (300122SZ), Watson Biotech (300142SZ), Wantai Biotech (603392SH) has HPV vaccine products on sale. Among them, Zhifei Biotech has been **Merck Sharp & Dohme (MRK.) since 2017US), Wantai Bio's self-developed HPV vaccine was launched in 2019, and Walvax's self-developed HPV vaccine was approved for marketing in 2022.
It is not difficult to find from the profit performance of these three companies in recent yearsAfter the launch of the HPV vaccine, the net profit attributable to the parent company basically continued to riseThis is very obvious in Zhifei Biotech and Wantai Biotech.
Although Kangle Guardian is still in the midst of continuous losses, and its performance has significantly underperformed its peers, judging from the performance of Zhifei Biotechnology, Watson Biotechnology, and Wantai Biology after selling HPV vaccinesIf the HPV vaccine of Kangle Guardian can be successfully marketed, it is very likely to quickly help the company turn losses into profits and get out of the loss dilemma.
What are the points worth paying attention to in the HPV vaccine track?
Looking forward to the future, from the perspective of industry development prospects, according to Frost & Sullivan data,HPV vaccine is the best-selling vaccine product in China and even in the world in 2022It is one of the most commercially successful vaccines in the world. HPV is the leading cause of many cancers such as cervical cancer, and vaccination is the recommended HPV prevention strategy, and the industry has a very bright future.
It is understood that in 2022, in the global vaccine market, the sales revenue of Merck's HPV vaccine Gardasil Gardasil 9 will reach 6.9 billion US dollars, ranking first among the top ten best-selling vaccines; Wantai Biotech ranked 7th, and its HPV vaccine, Xinkorin, also had a sales revenue of 13 in 2022$6.7 billion.
In the Chinese vaccine market, gardasil gardasil 9 and cecolin (cinkonine) ranked the top two of the top ten best-selling vaccines in 2022, respectively.
Frost & Sullivan's data also ** as HPV vaccines are expected to increase as well as higher vaccination ratesChina's HPV vaccine market is expected to reach RMB 73 billion by 2031, growing at a CAGR of 86%。
It can be seen that the HPV vaccine deserves to be the "star" variety of the "best track".
However, competition will naturally become fierce where there is a lot of money.
There are currently 6 licensed HPV vaccines in the worldFive of these vaccines have been approved in China. According to Frost & Sullivan, Gardasil 9 is the only approved 9-valent HPV vaccine in the world, and together with Gardasil, the global market share is expected to be approximately 81% in 2022, as shown in the chart below.
In addition to these that have been successfully developed, there are more manufacturers on the way.
The prospectus of Kangle Guardian showsThere are also 17 HPV vaccine candidates in clinical development in China, of which 11 have entered phase III clinical trialsMost HPV vaccine candidates in clinical development are priced no higher than Gardasil 9. In addition, a small number of companies are also developing HPV vaccines with a higher price tag than Gardasil 9.
With the increase of layout manufacturers, the HPV vaccine market has also changed from a blue ocean to a red ocean. The good news isThe 15-valent HPV vaccine candidate under development is the second most expensive of all HPV vaccines worldwide that have received or received IND approval.
In the face of competitive pressure, Kangle Guardian is also finding another way.
Kangle Guardian said in the survey of the reception agency on January 22The 9-valent HPV vaccine in the clinical trial stage will become the main product sold by the company, and the company will give priority to promoting the 9-valent HPV vaccine in the Southeast Asian market.
As high-income countries continue to include them in immunization programmes, the market for HPV vaccines in developed countries is almost saturated, but there is still a large market for HPV vaccines in developing countries, where the vaccination rate is low. It is a wise choice for Connaught Guardian to target the Southeast Asian market.
Recreation Guardian also said,The trivalent HPV vaccine can be positioned in the sinking market and targeted at the most sensitive groups. It should be noted thatLow-cost HPV vaccines are facing a squeeze from HPV age expansion.
On January 23, Wantai Biotech issued a performance reduction announcementIt is expected that the net profit attributable to the parent company in 2023 will be 12-13500 million yuan, a year-on-year decrease of 7466% to 7149%。
Wantai Biotech saidThe company's 2-valent HPV vaccine is affected by factors such as the expansion of 9-valent HPV vaccine and market competitionSales fell short of expectations, resulting in a significant decline in revenue and profit in the vaccine segment, of which the revenue of bivalent cervical cancer vaccine decreased by about 4.2 billion yuan from the same period last year.
It is worth paying attention to the impact of the age expansion of the 9-valent HPV vaccine on the commercialization potential of the 3-valent HPV vaccine.
Conclusion
In addition to the HPV vaccine, there are some other products under development in other fields, but the development of these product candidates is not very fast, and there is still a long way to go for commercialization.
In addition, some candidate products such as heptavalent norovirus vaccine and quadrivalent HFMD vaccine are mainly aimed at children, but the current fertility rate is not very good, and this factor may also affect the long-term commercialization prospects of these products.
On the whole, Kangle Guardian is one of the "star stocks" among Hong Kong IPO companies, and the prospects are worth looking forward to, but some of the above key points also need to be tracked.
Author: Yun Zhifeng Qi.