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On the evening of December 26, Kangle Guardian (833575), a listed company on the Beijing Stock Exchange, issued an announcement sayingIt plans to issue overseas listed foreign shares (H shares)** and apply for listing on the main board of the Hong Kong Stock Exchange.
Screenshot from the announcement of Kangle Guard, after half a year, Kangle Guardian has become a memorandum of understanding on cooperation between the Beijing Stock Exchange and the Hong Kong Stock ExchangeThe first company to be listed in the "North + H" dual market. Previously, on June 29, the Beijing ** Stock Exchange and the Hong Kong Stock Exchange signed a memorandum of understanding on cooperation in Beijing to launch a listing arrangement between Beijing and Hong Kong for eligible listed companies. Based on the above news catalyst, as of December 26**, Kangle Guardian rose by 30%. 
Screenshot from Flush Kangle Guard, as the first company to successfully enter the Beijing Stock Exchange with the fourth set of standards of "market value + R&D investment".Less than a year after the listing, it will be listed in Hong Kong, why?Two core products, very imaginative
Kangle Guardian was officially listed on the Beijing Stock Exchange on March 15 this year. According to the previous prospectus, Kangle Guardian focuses on the research and development of recombinant protein vaccines, and the product pipeline includes 10 recombinant human vaccine research projects, of which the core pipeline is recombinant trivalent HPV vaccine and recombinant nine-valent HPV vaccine, the fastest research and development indications have entered the third phase of clinical trials, and the time for submitting BLA applications is expected to be submitted in 2025 and 2026 respectively, according to the latest news from Kangle Guard, the BLA time of the two indications is expected to be advanced by one year. In addition, there are a number of recombinant vaccines such as norovirus, respiratory syncytial virus, herpes zoster, hand, foot and mouth disease in the preclinical research stage. 
Screenshot from the prospectus of Kangle Guard: The two HPV vaccines in the clinical stage of Kangle Guardian have great potential. First of allTrivalent HPV vaccineAt present, there is only Kangle Guard in Chinaand is already on the eve of listing. Compared with the bivalent and quadrivalent HPV vaccines that have been marketed, trivalent HPV covers HPV 58, the third most high-risk type of cervical cancer in East Asia, and can increase the protection range to 78%. , and will also have more advantages in terms of **. For the nine-valent HPV vaccine, in the context of extreme involution in domestic research and development,The recombinant 9-valent HPV vaccine of Kangle Guardian is differentiated enough in the selection of indications. The currently approved HPV vaccine products in China are mainly for female indications, but HPV vaccines can also provide protection against some male cancers and lesions caused by HPV infection. According to the latest research report of Great Wall**, the number of men (9-45 years old) of HPV vaccination age in China will reach 3 in 20204.4 billion people. 
Screenshot from Great Wall ** Research Report Therefore, in the global HPV disease market, male indications are also a must to compete. According to the latest quarterly financial report of Kangle Guard, the recombinant 9-valent HPV vaccine (male indication) has entered the phase III clinical trial stage, and the enrollment of subjects is currently underway. At present, the only 9-valent HPV vaccine on the market in the world is Merck's Gardasil-9, with cumulative sales of $7 billion in the first three quarters of 2023. In the domestic HPV vaccine market, although there are bivalent vaccines from Walvax Biologics, Wantai Biologics, GSK, and Merck's own quadrivalent vaccines, the nine-valent vaccine Gardasil-9 still occupies more than 90% of the market share. This is still the record of gardasil-9 only in the female indication track. Previously, it was reported that the marketing application for a new indication of Gardasil-9 was accepted in September, with a high probability of preventing HPV infection in men. Judging from the progress of the research and development of the nine-valent HPV vaccine (male indication).Merck's Gardasil-9 is likely to hit the line first, and Recombinant 9-valent HPV vaccine is the second fastest to be developed, and it is expected to submit a BLA application in 2027, which is expected to make up for the gap in market expectations caused by the relative backwardness of female indications. In addition, there is only Shanghai Bowei Biotech has carried out the layout, which is relatively backward in speed and entered the phase 1 clinical stage in September last year. The higher the "price" of the HPV vaccine, the more types of HPV virus subtypes that can be prevented, and the higher the protection rate, which is also the main reason why the 9-valent vaccine can occupy more market space than the bivalent and quadrivalent vaccines. In addition to independently developing quadrivalent and nine-valent HPV vaccines, Kangle Guardian also took the lead in cooperating with Chengda Biotechnology to lay out the 15-valent vaccine, and obtained the approval for clinical trials in early 2022. Under the premise that the global HPV vaccine market is in short supply, the extension of Kangle Guardian to Hong Kong stocks this time can make better use of Hong Kong's international resources and market advantages, and give full play to the commercialization prospects of the two core products. The choice of the Beijing Stock Exchange after the IPO shrunk
The actual IPO of Kangle Guardian on the Beijing Stock Exchange was 30.8 billion yuan. In fact, the IPO of Kangle Guardian was intended to raise about 300.8 billion to 345.9 billion yuan.
Regarding the big shrinkage of the IPO, Kangle Guardian once said, "It is a decision made with reference to the recent capital market situation, combined with the company's business development plan, fully considering the on-demand financing and the diversification of future financing channels after the public offering ** and listing on the Beijing Stock Exchange." The choice of Kangle Guardian to list in Hong Kong again after being listed on the Beijing Stock Exchange for less than a year is also the most direct response to the big shrinkage of the IPO: burning money too fast. From the perspective of the R&D side of Kangle Guard, the three indications of the two products have entered the third phase of clinical trials, which will cost a lot of money, and more than ten preclinical products also need to be continuously invested. In terms of production capacity, one of the major uses of Kangle Guard's IPO fundraising is to build its own industrialization base in Kunming, and trial production has been launched in August this year, preparing for the future product launch. Once the product is listed as scheduled, it will directly compete with Zhifei Biology and Wantai Biology that have built a mature sales system in the market, and it is difficult to reduce the marketing costs linked behind the fierce market fight. From 2020 to 2022, the R&D expenses of Kangle Guardian are 11.8 billion yuan, 21.8 billion and 23.7 billion, and the R&D expenses in the first three quarters of this year were as high as 17.7 billion yuan, net profit loss attributable to the parent company of 22.5 billion yuan, and the cash on the account has also been urgent, leaving only 25.3 billion yuan, Kangle Guardian is in urgent need of refinancing and blood transfusion. 
Screenshot from the latest quarterly financial report of Kangle Guard, "North + H" is based on the extension of the "A+H" and "Three + H" models, which provides more convenience for overseas financing of listed companies on the Beijing Stock Exchange. It is precisely this opportunity that Kangle Guardian has seized and chose to go to Hong Kong for re-listing to help the clinical and commercialization of its core pipeline. summary
Summary
More and more biotechnology companies are setting their sights on the more friendly Beijing Stock Exchange. According to incomplete statistics, since the beginning of this year, more than 10 companies have started the counseling journey of the Beijing Stock Exchange. If Kangle Guardian successfully goes public in Hong Kong, the Beijing Stock Exchange will also be more attractive to many biotechnology companies that are still in flux. At the same time, this new mechanism also provides the possibility for biopharmaceutical companies listed in Hong Kong to go all the way to the "north" to list on the Beijing Stock Exchange. Note:The information is from the official websites of major companies and public information sources. The copyright belongs to the original author, only for readers to study, research or enjoy, and shall not be used for commercial purposes, if it involves the content of the work, copyright and other issues, please contact and delete within 30 days;This *** is neutral to the content, statements, and opinion judgments shared, and does not provide any express or implied guarantee for the authenticity, reliability or completeness of the content contained, and is only for readers' learning and reference.