智通财经APP讯，广生堂(300436.SZ)公告，2025 年3月10日，公司创新药控股子公司福建广生中霖生物科技有限公司收到北京市药品监督管理局下发的《优化创新药临床试验审评审批试点项目确认书》，同意GST-HG131联合GST-HG141 的II期临床研究纳入试点项目，将有效缩短临床审评审批周期。
基于GST-HG131和GST-HG141的临床前研究和临床研究结果，GST-HG131 片对HBsAg具有显著抑制作用，GST-HG141片对HBV DNA和pgRNA具有显著抑制和耗竭作用，两者在抗病毒机制上预计存在协同互补。GST-HG131 联合 GST-HG141 的 II期临床研究旨在探索基于核苷(酸)类似物NUC基础治疗上， GST-HG131 片联合GST-HG141片在慢性乙型肝炎患者中的安全性、耐受性、有效性，以期为乙肝患者提供更有效的治疗选择，致力于实现公司乙肝登峰计划。
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