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]

Core Viewpoint - The phase II clinical trial results of Hepu Pharmaceutical's innovative drug Hepulapide combined with PEG interferon for chronic hepatitis B treatment have shown significant efficacy, meeting the sterilizing cure standards set by AASLD and EASL [1][5]. Company Summary - Hepu Pharmaceutical is preparing to initiate phase III clinical trials for Hepulapide in treating chronic hepatitis B, aiming for market registration to benefit patients globally [3]. - The company has developed Hepulapide, a class 1 innovative drug that blocks HBV from entering the cell nucleus, addressing a critical gap in current hepatitis B treatments [4]. Industry Summary - Chronic hepatitis B, caused by HBV, is a highly prevalent infectious disease, with approximately 296 million people infected globally as of 2022, including about 89 million in China [3]. - Current treatments for hepatitis B, such as nucleos(t)ide analogs and interferons, do not cure the disease due to the persistence of cccDNA in the cell nucleus, which can reactivate HBV replication [4].