华领医药-Ｂ(02552.HK)完成HMS5552与二甲双胍联合用药治疗III期临床试验所有受试者入组
格隆汇8月30日丨华领医药－Ｂ(02552.HK)发布公告，公司完成dorzagliatin(HMS5552)与二甲双胍联合用药的III期临床试验完成受试者入组，故预期将于2020年第二季度公布最新试验结果。
Dorzagliatin为第三代2型糖尿病(T2D)的治疗药物，原因为其具有潜力阻止T2D的恶化，目前市面上现有药物皆尚无法阻止其恶化。III期试验于集团II期试验设计后进行，展示强大的安全性及疗效的数据，有望具有可能缓解疾病的作用。
该试验是一项随机、双盲、安慰剂对照的临床试验，由中日友好医院的杨文英教授领导正在中国70多家临床中心开展，受试者以dorzagliatin与二甲双胍联合用药对比二甲双胍单药治疗，并以1：1的比例随机分配，设有24周双盲治疗期， 28周开放治疗期，将对dorzagliatin联合二甲双胍在相关糖尿病患者人群中治疗24 周的有效性终点和52周的安全性进行评估。在美国患者人群完成的早期临床研究中，dorzagliatin联合二甲双胍显示优于二甲双胍单药治疗的临床效果，且提示 dorzagliatin良好的安全性。
在dorzagliatin单药治疗(HMM0301)和联合二甲双胍治疗(HMM0302)两项试验均取得52周的三期阳性结果后，公司计划向国家医药产品管理局(NMPA)提交一份关于dorzagliatin作为在中国一类用药的新药申请(NDA)。
根据披露，Dorzagliatin是华领医药正在研发的一款糖尿病创新口服药物，旨在通过对2型糖尿病患者血糖传感器葡萄糖激酶的功能修复，重塑人体血糖稳态平衡，控制渐进性退变性疾病发展，达到治疗2型糖尿病的目的。目前该在研药物处于Ⅲ期临床研发的冲刺阶段，一旦成功上市，dorzagliatin有望成为治疗2型糖尿病的新一代基础药物，既可以作为单药使用治疗初发和早期2型糖尿病患者，也可以采用糖尿病个性化治疗的方案，与当前临床使用的抗糖尿病药物联合使用。
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