Group 1 - Hepatitis B virus (HBV) infection is a significant global public health issue, with chronic HBV potentially leading to cirrhosis and liver cancer if not controlled [1][2] - Current treatments for chronic HBV do not achieve a complete cure, with existing drugs unable to eliminate the virus entirely [2][4] - HepaPlus, a drug developed by Shanghai HepaPlus Pharmaceutical, is one of the few candidates aiming for sterilizing cure in hepatitis B treatment [1][4] Group 2 - The recent Phase II clinical trial results presented at the 2025 European Association for the Study of the Liver (EASL) conference showed that HepaPlus significantly improved the response rate of HBV DNA when combined with PEG interferon [1][5] - The trial included 96 patients, with an average age of 35.3 years, and demonstrated response rates of 78.3%, 87.5%, and 70.8% for different doses of HepaPlus compared to 58.3% for the placebo group [5][6] - The study indicated that a portion of participants achieved cccDNA clearance after 24 weeks of treatment, meeting the criteria for sterilizing cure [1][6] Group 3 - HepaPlus works by blocking HBV infection through the NTCP receptor and preventing rcDNA from forming cccDNA, while PEG interferon enhances immune response to deplete cccDNA [5][6] - The trial showed good tolerability for HepaPlus, with most adverse effects attributed to interferon, and serious adverse events not exceeding grade 2 [6] - The company plans to initiate a global Phase III clinical trial with over 500 participants to further validate the sterilizing cure potential by the end of 2027 [7]

Core Insights - The Chinese innovative drug industry is undergoing a significant transformation, moving from a catch-up phase to a leading position in certain areas, particularly in liver disease research [1][2] - At the recent EASL Congress 2025, 13 research teams from China presented findings on various aspects of liver disease, showcasing the country's advancements in this field [1] - The clinical trial results for the hepatitis B drug Hepalapide have shown promising outcomes, achieving sterilizing cure standards, which has garnered significant attention from experts [2] Industry Overview - The global transaction value involving Chinese innovative drug companies reached $51.9 billion in 2024, with upfront payments totaling $4.1 billion, indicating increasing international interest [4] - The proportion of molecules introduced by global pharmaceutical companies from Chinese innovative drug firms rose from 0% in 2019 to 31% in 2024, highlighting the growing importance of Chinese innovation in the global pharmaceutical landscape [4] - Hepalapide is expected to enter Phase III clinical trials, potentially becoming the first drug capable of clearing cccDNA, offering new hope for chronic hepatitis B patients [4] Government Support - The rapid development of Chinese innovative drugs is supported by a series of government policies since 2015, facilitating a shift from generic to innovative drug development [5] - Reforms in drug review and approval processes have accelerated the market entry of innovative drugs, while the establishment of various stock exchanges has provided crucial financing channels for unprofitable innovative drug companies [5] - The successful development of drugs like Hepalapide aligns with the goals set out in the "Healthy China 2030" initiative, indicating a strong market outlook for these innovations [5]

图说：贺普药业一类创新药贺普拉肽联合PEG干扰素治疗慢性乙肝的二期临床试验结果在2025年第60届欧洲肝病学会年会进行了口头报告并公布（图片来 源：企业供图） 贺普药业进一步对记者表示，公司即将启动贺普拉肽治疗慢性乙肝的三临床试验。"公司将全力推进贺普拉肽联合干扰素治疗乙肝的三期临床研究和注册上 市，早日造福我国和全球广大乙肝患者。"公司相关负责人表示。 据介绍，乙肝是由乙型肝炎病毒（HBV）感染所引起、以肝脏受累为主的传染性疾病。它是发病率最高的病毒性肝炎，若未得到有效的抗病毒治疗，慢性 乙肝患者的疾病进程可能会逐渐发展为肝硬化、肝衰竭、肝癌。据世界卫生组织统计，2022年，全球有约2.96亿人有慢性乙肝感染；其中，我国目前乙肝感 染者约有8900万，慢性乙肝患者约为2000万，每年新发病例约100万。 本报讯 （记者金婉霞）5月10日，记者从上海贺普药业股份有限公司（下称：贺普药业）获悉，由公司自主研发的一类创新药贺普拉肽联合PEG干扰素治疗 慢性乙肝的二期临床试验结果已在2025年第60届欧洲肝病学会年会进行了口头报告并公布。试验结果显示，贺普拉肽联合PEG干扰素可显著提高乙肝病毒 （HBV DNA）的 ...