智通财经APP讯,广生堂(300436.SZ)发布公告,公司创新药控股子公司福建广生中霖生物科技有限公司(简称“广生中霖”)于近日收到国家药品监督管理局下发的关于乙肝治疗创新药GST-HG131联合GST-HG141的临床试验申请《受理通知书》,拟针对核苷(酸)类似物NUC经治乙肝患者,挑战临床治愈乙肝。前述II期临床研究已于日前被纳入优化创新药临床试验审评审批试点项目,将有效缩短本次临床试验申请的审评审批周期。
本次GST-HG131联合GST-HG141的II期临床试验申请获得受理,尚需进一步获得批准后才可开展临床研究,能否获得批准开展临床存在不确定性。
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