Simplified Chinese
Kangtai Biological’s 60-microgram hepatitis B vaccine for “preventing viral rebound” has received clinical trial approval, offering a globally innovative strategy that could pave the way for functional cure of chronic hepatitis B.
Release date:
2025-12-18
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Abstract
Recently, the recombinant hepatitis B vaccine (Saccharomyces cerevisiae) (60 μg), developed by Kangtai Biological, has received a “Notice of Approval for Clinical Trials” from the National Medical Products Administration, approving the conduct of a clinical trial to evaluate the prevention of HBsAg relapse in individuals achieving functional (clinical) cure of chronic hepatitis B.
The 60-microgram hepatitis B vaccine, for which the clinical supplemental application has been approved, works by inducing the production of high levels of hepatitis B surface antibodies and establishing long-lasting immune memory, thereby helping individuals who have cleared chronic hepatitis B surface antigen to maintain a sustained state of functional cure—i.e., preventing viral rebound. In terms of pipeline positioning, it holds promise as a globally innovative strategy to sustain durable remission in patients with chronic hepatitis B who have achieved functional cure after discontinuation of therapy.
Looking at the global market, the hepatitis B treatment segment exhibits both substantial value potential and a significant unmet clinical need. According to the World Health Organization, approximately 300 million people worldwide are living with chronic hepatitis B, and the global hepatitis B therapeutics market is projected to reach RMB 124.6 billion by 2030. In China alone, there are an estimated 75 million individuals with chronic hepatitis B, and the domestic market for hepatitis B treatment is expected to exceed RMB 70 billion by 2030. Nevertheless, current therapies fall short of addressing key unmet clinical needs, particularly the lack of strategies that can sustain long-term efficacy and reduce the risk of viral rebound. If this vaccine successfully expands its approved indications, it could markedly enhance therapeutic outcomes, fill a critical gap in the international market, and potentially unlock demand from tens of millions of additional patients.
As a leading enterprise that has grown alongside China’s vaccine industry, Kangtai Biological was founded in 1992 to fulfill the historic mission of introducing and mastering recombinant hepatitis B vaccine technology. Over the past three decades, Kangtai has remained deeply committed to the research and development of globally innovative vaccines. Among its offerings, the 60-microgram hepatitis B vaccine—a groundbreaking product launched in 2010—has now received approval for an expanded clinical trial application. This milestone positions the company to uniquely address the full spectrum of hepatitis B care, spanning prevention, treatment, and relapse prevention, thereby offering greater hope for cure to patients and providing a powerful new impetus as Kangtai advances toward becoming a globally competitive biopharmaceutical innovator.
As a leading enterprise in China’s vaccine industry, Kangtai Biological boasts industry‑leading sales scale and R&D capabilities, with its proprietary product revenues ranking among the highest in the sector. Over the past five years, the company has consistently held the top position in the industry for the total number of approved products, underscoring its exceptional R&D translation and commercialization prowess.
The company adheres to an R&D strategy of “New in China, New Globally,” and its pipeline boasts the highest overall value in the industry: its pentavalent vaccine, which is at the forefront of domestic development, is poised to disrupt the monopoly held by imported products; meanwhile, its Klebsiella pneumoniae vaccine and its RSV/hMPV combination vaccine both hold the potential to become first-in-class therapies.
In implementing its internationalization strategy, the company adopts a dual‑pronged “attracting investment and going global” approach. As one of the most internationally advanced players in China’s vaccine industry, Kangtai has undertaken all vaccine technology transfer projects for major international biopharmaceutical companies operating in the Chinese market. In recent years, the company’s innovative products have initiated registration processes in numerous densely populated countries along the Belt and Road Initiative, with its future strategic footprint poised to reach nearly half of the world’s newborn population.
Looking ahead, Kangtai Biological will accelerate its strategic shift from disease prevention to therapeutics, focusing on cutting-edge global technological innovation and industrialization. The company is committed to becoming a leading biotechnology enterprise with international influence, continuously advancing the sustainable development of global public health.
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