君圣泰医药-B(02511):全球首创抗炎代谢调节剂HTD1801完成2型糖尿病III期临床研究 展现持续52周的综合获益与安全性优势

智通财经
Oct 31, 2025

智通财经APP讯,君圣泰医药-B(02511)公布,HTD1801在2型糖尿病(T2DM)患者中开展的两项 III期临床试验(SYMPHONY-1和SYMPHONY-2)已顺利完成,52周研究(含开放标签延长期(OLE))取得积极的疗效与安全性结果。

两项III期临床研究的52周数据充分验证了HTD1801疗效的持久性,并进一步凸显其为T2DM患者带来的长期综合临床获益。君圣泰医药计划于今年内向国家药品监督管理局(NMPA)药品审评中心(CDE)递交HTD1801治疗T2DM适应症的新药上市申请(NDA)。

两项研究中,双盲期HbA1c达标(HbA1c <7.0%)的患者比例在第52周时仍保持稳定。与此同时,HTD1801在降低血脂方面的疗效亦长期稳定,包括低密度脂蛋白胆固醇(LDL-C)与非高密度脂蛋白胆固醇(non-HDL-C)均显着下降。HTD1801长期治疗还可持续降低与心血管事件及T2DM患者临床结局密切相关的炎症标记物 γ-谷氨酰转移酶(GGT)和超敏C反应蛋白(hs-CRP)。

HTD1801在长期治疗中展现出良好的安全性与耐受性,与双盲期结果保持一致。对于接受HTD1801治疗的患者,治疗期延长不会增加其不良事件的类型与严重程度。

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