福建广生堂药业股份有限公司关于乙肝治疗一类创新药奈瑞可韦GST-HG141完成III期临床试验受试者入组的公告

Core Viewpoint - The company has completed the enrollment of 578 participants in the Phase III clinical trial for its innovative hepatitis B treatment, GST-HG141, which aims to evaluate its efficacy and safety in patients with chronic hepatitis B who have poor responses to antiviral therapy [1][3]. Group 1: Clinical Trial Details - GST-HG141 is a novel hepatitis B core protein/nucleocapsid regulator, representing a first-in-class (FIC) potential drug with no similar products currently available globally [2]. - The Phase III trial is a randomized, double-blind, placebo-controlled, multi-center study, primarily led by Shulan (Hangzhou) Hospital and Peking University First Hospital [1]. - The trial's main objective is to assess the effectiveness and safety of GST-HG141 in patients who have not responded well to antiviral treatments [1]. Group 2: Research and Development Progress - Previous Phase Ib and II trials have shown significant efficacy and safety for GST-HG141, with rapid onset of action and notable suppression of HBV DNA and pgRNA levels, indicating potential effectiveness against HBV cccDNA [2]. - The results from the Phase II clinical study are set to be presented as a late-breaking abstract at the American Association for the Study of Liver Diseases (AASLD) in November 2024 [2]. - GST-HG141 has been included in the list of breakthrough therapy designations by the National Medical Products Administration (NMPA) in December 2024 [2]. Group 3: Future Steps and Considerations - Following the completion of participant enrollment, the company will continue to advance the clinical trial according to the established protocol and seek regulatory approval from the national drug review authorities before market launch [3]. - The company has prior experience in successfully developing innovative drugs, such as the anti-COVID-19 drug, but acknowledges the long and risky nature of drug development, which may be influenced by various factors [3].