Economic Observer reporter Huang YifanHalf a year after the Beijing Stock Exchange and the Hong Kong Stock Exchange jointly signed a memorandum of cooperation, the first "North + H" listing preparatory enterprise came.
On December 26, the Beijing Stock Exchange-listed company Kangle Guardian (833575BJ) announced that it plans to issue overseas listed foreign shares (H) shares** and apply for listing on the Hong Kong Stock Exchange.
According to the announcement of Kangle Guard, the funds raised will be used for the clinical trials and approval of the company's core products, the research and development of a number of preclinical projects, the pre-production preparation and production process improvement of the Kunming industrialization base, the improvement of the commercialization network construction, international clinical and localized production, international market expansion, working capital and other general corporate purposes.
Why did you choose to issue H shares at this time?According to the announcement of Kangle Guard, the action is intended to "further improve the company's capital strength and comprehensive competitiveness, and further promote the internationalization strategy".
Kangle Guardian said in the announcement that the company will fully consider the interests of existing shareholders and the situation of domestic and foreign capital markets, and choose an appropriate time and issuance window to complete the issuance and listing within the validity period of the resolution of the general meeting of shareholders (that is, 18 months from the date of deliberation and approval by the company's general meeting of shareholders or other periods agreed to extend).
In addition, Kangle Guardian also reminded in the announcement that the issuance and listing still need to be submitted to the company's general meeting of shareholders for deliberation, and need to obtain the approval, approval or filing of relevant ** authorities, regulatory agencies and ** exchanges such as the China ** Regulatory Commission and the Hong Kong Stock Exchange.
A person listed on the Beijing Stock Exchange said about the planned listing of Kangle Guardian in Hong Kong, "As the first innovative unprofitable enterprise listed in accordance with the fourth set of standards of the Beijing Stock Exchange, Kangle Guardian represents the financing and development support of the Beijing Stock Exchange for specialized, special and new small and medium-sized enterprises. The listing plan on the Hong Kong Stock Exchange is in line with the needs of such enterprises to lay out overseas business, expand international financing platforms, enhance international brands, and be in line with international standards."
It is understood that Kangle Guardian is a biomedical enterprise with structure-based antigen design as the core technology, mainly engaged in the research, development and industrialization of recombinant protein vaccines. Up to now, Kangle Guard's vaccine products are in the research and development stage, and no vaccine products have been put on the market.
According to the financial report, from 2020 to 2022, the R&D investment of Kangle Guardian will be 11.8 billion yuan, 21.8 billion and 23.7 billion yuan. When it will be listed on the Beijing Stock Exchange in 2023, Kangle Guardian will adopt the fourth set of standards of the Beijing Stock Exchange, that is, "the expected market value is not less than 1.5 billion yuan, and the total R&D investment in the last two years is not less than 50 million yuan", and it is also the first company to adopt this standard to be listed on the Beijing Stock Exchange.
This time, Kangle Guardian will be listed in Hong Kong, and it will apply the "North + H" mechanism previously launched by the Beijing Stock Exchange.
On June 29 this year, the Beijing Stock Exchange and the Hong Kong Stock Exchange signed a memorandum of understanding on cooperation to launch the "North + H" mechanism to support eligible enterprises to list in the two places. In his speech on the same day, Sui Qiang, general manager of the Beijing Stock Exchange, said that the launch of the listing arrangement between Beijing and Hong Kong is an important measure to promote the institutional opening of the capital market, continue to deepen the reform of the Beijing Stock Exchange, and respond to market demand under the overall planning of the China Securities Regulatory Commission, which will further broaden the scope of benefits of the "A+H" model in the mainland and Hong Kong, and facilitate more enterprises to accelerate their development with the help of the Beijing and Hong Kong markets.
At present, Kangle Guardian is the first company to prepare for the "North + H" dual listing after the signing of a memorandum of understanding on cooperation between the Beijing Stock Exchange and the Hong Kong Stock Exchange this year.
According to the Listing Rules of the Hong Kong Stock Exchange, as a non-profitable biopharmaceutical company, Connaught Guardian should comply with Chapter 18A of the Main Board Listing Rules, which means that at least one core product of a biotech company has passed the concept stage.
It has been observed that most of the previous 18A companies have completed the listing of a core product through the concept stage. The difference is that the commercialization of the core products of Kangle Guardian is imminent, and if it is successfully listed on the Hong Kong Stock Exchange, it may complete the "B" in a short period of time after listing.
According to the regulations of the Hong Kong Stock Exchange, companies listed under Rule 18A are required to carry a "B" logo in their share names as a reminder to investors before certain conditions are met. "Pick B" needs to meet the conditions of annual revenue greater than HK$500 million and market value greater than HK$4 billion. This criterion is generally understood as a consideration of biotech's profitability, product development pipeline, and commercialization capabilities.
According to the recent announcement of Kangle Guard, the company's recombinant trivalent HPV vaccine, recombinant 9-valent HPV vaccine (female indication) and recombinant 9-valent HPV vaccine (male indication) have all entered the clinical stage, and the recombinant 15-valent HPV vaccine has obtained the clinical trial approval notice. If the clinical trial progresses well, the company will submit a Biologics License Application (BLA) for the trivalent HPV vaccine in 2024 and the BLA for the 9-valent HPV vaccine in 2025.
In an interview earlier this year, Kangle Guardian told reporters that the trivalent HPV vaccine is the company's most advanced product in research and development, and it is initially considered that it is between the commercially available bivalent HPV vaccine and the quadrivalent HPV vaccine, and will eventually be determined in combination with the market situation when the product is approved for marketing. For the vaccine industry, the revenue contribution mainly depends on the full fiscal year of the year following the approval of the product, because the first department purchases vaccines through bidding or negotiation on the provincial public resource trading platform, and the enterprise enters the first procurement catalog after winning the bid, and then goes on sale. "If the process goes well, it will generally take half a year, and the specific revenue company will determine the specific sales model and revenue recognition criteria in the future."
In terms of internationalization, Kangle Guardian is the first company in China to independently conduct clinical trials of HPV vaccines overseas. According to the recent announcement, the nine-valent HPV vaccine was approved for phase clinical trials in Indonesia in November this year, and all subjects have been enrolled, and it is expected to submit BLA to the Indonesian drug regulatory department in 2025. The company is in close communication with a number of international organizations, and will continue to strengthen various cooperation with other regions and countries, pharmaceutical companies or non-** organizations through external licensing or joint venture cooperation in the future. At the same time, the company will also actively respond to the WHO's international vaccine procurement plan and make preparations for WHO PQ certification in the construction of production workshops.