康华生物(300841):人二倍体狂犬疫苗龙头创新升级 上实系国资入主开启增长新篇章

Core Investment Logic - The company's core product, the freeze-dried human rabies vaccine (human diploid cells), is recognized as the "gold standard vaccine" by the World Health Organization (WHO), demonstrating significant advantages in safety and immunogenicity [1] - The domestic rabies vaccine market is primarily dominated by Vero cell vaccines, indicating a substantial replacement opportunity for human diploid vaccines, which currently have low penetration [1] - The rabies disease has a high fatality rate, creating a strong demand for vaccination, thus providing a stable sales foundation for the product [1] - Since its listing in 2014, the company has sold over 30 million doses, covering all 31 provincial regions in China [1] - Frost & Sullivan predicts that the market size for human diploid rabies vaccines could reach approximately 10.18 billion yuan by 2030 [1] - The company's performance decline is gradually narrowing, with Q1/Q2/Q3 revenue changes of -55.70%/-19.49%/+11.54% year-on-year [1] - The company has resumed production of the ACYW135 group meningococcal polysaccharide vaccine, which has been exported to 10 countries, potentially driving continuous performance improvement [1] Research and Development Pipeline - The company's lead six-valent norovirus vaccine is one of the highest-priced norovirus vaccines currently in development globally, with broad protection against mainstream strains (e.g., GI.1, GII.2) [2] - The vaccine has received clinical trial approvals in Australia, the United States, and China, showcasing recognized technical barriers [2] - In January 2024, the company signed an exclusive licensing agreement with HilleVax for overseas rights, receiving an upfront payment of $15 million and potential milestone payments up to $255.5 million, along with sales royalties [2] - This makes the company the only domestic entity to achieve a license-out for a norovirus vaccine, highlighting the global value of its innovative products [2] - Frost & Sullivan forecasts that the norovirus vaccine market could grow from 1.53 billion yuan to 22.93 billion yuan from 2026 to 2031, with a compound annual growth rate of 71.85% [2] - This product is expected to significantly contribute to the company's future revenue, facilitating a strategic transition from a single rabies vaccine leader to a multi-category vaccine platform [2] Control Change and Strategic Empowerment - On November 7, 2025, the company completed a change in control, with Shanghai Wankexin Biotechnology becoming the controlling shareholder, holding 21.91% of shares and 29.99% of voting rights [3] - This marks the first instance of a private equity fund controlling a listed company in the vaccine industry through a "fund + industry" model, providing a strategic template for collaboration [3] - The expected benefits from this control change include enhanced financing efficiency, innovation in research and development, channel expansion, and globalization [3] - The original shareholders have committed to a net profit of no less than 728 million yuan from 2025 to 2026, along with a minimum of 260 million yuan in R&D investment, ensuring robust support for performance growth and pipeline advancement [3][4] - The company is positioned to leverage the governance optimization and resource synergy from the control change, making it a core focus for medium to long-term investment [4] Financial Performance and Projections - The company reported a narrowing decline in performance, with Q1/Q2/Q3 revenue changes of -55.70%/-19.49%/+11.54% year-on-year, and a net profit of 189 million yuan for the same period [4] - The original controlling shareholder's profit commitment provides a buffer for the company, with projected revenues of 1.299 billion yuan, 1.530 billion yuan, and 1.658 billion yuan for 2025-2027, reflecting year-on-year growth rates of -9.25%, 17.76%, and 8.33% respectively [4] - The projected net profits for the same period are 301 million yuan, 501 million yuan, and 638 million yuan, with year-on-year growth rates of -24.60%, 66.77%, and 27.26% respectively [4] - The company is covered with a recommendation rating, reflecting the anticipated recovery in performance and the strategic opportunities arising from the control change [4]