Core Viewpoint - The clinical results of the innovative drug GST-HG131 for hepatitis B treatment have been recognized by the American Association for the Study of Liver Diseases (AASLD) and accepted for presentation at the 2025 Liver Meeting, indicating significant progress in the company's research efforts [2][3]. Group 1: Company Overview - Fujian Guangshengtang Pharmaceutical Co., Ltd. has a subsidiary, Fujian Guangsheng Zhonglin Biotechnology Co., Ltd., which is focused on innovative drug development [2]. - GST-HG131 is the first oral HBsAg inhibitor to complete Phase II clinical trials globally, demonstrating good accessibility and patient compliance [3][7]. Group 2: Clinical Trial Results - Phase II clinical trials showed a rapid decline in HBsAg levels among patients, with the fastest reduction of approximately 0.8 Log10 IU/mL within 7 days [3]. - In the third group (30mg, BID, three-month treatment), the average HBsAg level decreased to 12.88%, representing an 87.12% reduction, with 76.5% of patients achieving HBsAg levels ≤100 IU/mL, a key indicator of partial cure [3][4]. Group 3: Market Context - Hepatitis B is a significant public health issue, with approximately 254 million people globally infected and around 1.1 million deaths attributed to the disease in 2022 [5]. - In China, the prevalence of HBsAg is 6.1%, with 86 million chronic HBV infections, indicating a substantial market opportunity for effective treatments [5]. Group 4: Future Prospects - The combination of GST-HG131 and GST-HG141 is expected to challenge clinical cure for hepatitis B, with the treatment plan included in the national "Optimizing Innovative Drug Clinical Trial Review and Approval Pilot Project" [4]. - The World Health Organization aims to eliminate viral hepatitis as a public health threat, with specific targets for reducing new infections and mortality rates, highlighting the potential impact of innovative treatments like GST-HG131 [5].
福建广生堂药业股份有限公司关于乙肝治疗一类创新药GST-HG131 研究成果被美国肝病研究协会接受为年会最新突破摘要报告的公告