康泰生物60μg乙肝疫苗用于“防复阳”获批临床 有望为慢性乙肝功能性治愈提供全球创新策略

Core Viewpoint - Shenzhen Kangtai Biological Products Co., Ltd. has received approval from the National Medical Products Administration for its recombinant hepatitis B vaccine (60μg) to conduct clinical trials aimed at preventing HBsAg reversion in patients with functional cure of chronic hepatitis B [1][2]. Group 1: Clinical Development - The approved 60μg hepatitis B vaccine works by inducing high levels of hepatitis B surface antibodies, establishing long-lasting immune memory to help maintain a sustained functional cure state in patients who have cleared the hepatitis B surface antigen [1]. - The vaccine is positioned as a global innovative strategy to maintain sustained cure in chronic hepatitis B patients after discontinuation of treatment [1]. Group 2: Market Potential - The global market for hepatitis B treatment is projected to reach 124.6 billion yuan by 2030, with approximately 300 million chronic hepatitis B infected individuals worldwide [1]. - In China, there are about 75 million chronic hepatitis B infected individuals, and the domestic market for hepatitis B treatment is expected to exceed 70 billion yuan by 2030 [1]. - There is a significant unmet clinical need in hepatitis B treatment, with a lack of strategies to consolidate long-term efficacy and reduce the risk of reversion [1]. Group 3: Company Background - Kangtai Biological was established in 1992 to undertake the mission of introducing recombinant hepatitis B vaccine technology to China [2]. - The 60μg hepatitis B vaccine, launched in 2010, is a global innovative product, and the recent approval marks a significant step for the company to cover the entire cycle of hepatitis B "prevention + treatment + reversion prevention" needs [2]. - This development is expected to provide greater hope for hepatitis B patients and support the company's goal of becoming a global innovator in biopharmaceuticals [2].