轩竹生物-B(02575)：安奈拉唑钠新适应症获批开展III期临床试验

智通财经

Apr 15

智通财经APP讯，轩竹生物-B(02575)发布公告，本集团自主研发的创新药安奈拉唑钠肠溶片(商品名：安久卫®)近日获得中国国家药品监督管理局药品审评中心(CDE)批准，开展含安奈拉唑钠肠溶片的铋剂四联疗法根除幽门螺杆菌的III期临床研究。

该研究是一项多中心、随机、双盲双模拟、阳性药平行对照的III期临床试验，计划纳入556例幽门螺杆菌阳性成人受试者，以含艾司奥美拉唑镁的铋剂四联疗法为对照，评价含安奈拉唑钠的铋剂四联疗法连续给药14天用于幽门螺杆菌根除治疗的有效性、安全性及群体药代动力学特征，主要终点为治疗结束后第28天经13C-尿素唿气试验(13C-UBT)确认的幽门螺杆菌根除率。

幽门螺杆菌是一种革兰氏阴性微需氧病原菌，与多种胃部疾病密切相关，包括胃溃疡、慢性进行性胃炎及胃癌。根据弗若斯特沙利文，中国幽门螺杆菌感染率约为44%，治疗幽门螺杆菌感染药物市场规模在持续扩大，2024年中国幽门螺杆菌感染治疗药物市场规模已达人民币55亿元，预测2029年将增至人民币68亿元，到2035年将达到人民币126亿元。

本次安奈拉唑钠新适应症III期临床试验申请获批，有助于拓展产品适应症范围，提升本公司在消化疾病治疗领域的影响力，对本公司长远发展及商业化布局具有重要意义。

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