華領醫藥(02552.HK)治療糖尿病新藥獲上海藥品生產許可證
華領醫藥(02552.HK)公布,經過藥品上市許可持有人(MAH)體系審核和現場核查後,公司已獲得由上海市藥品監督管理局頒發的在研全球首創新藥多扎格列艾汀(dorzagliatin)藥品生產許可證。
集團指,今年以來成功完成兩項三期新藥上市註冊臨床試驗的關鍵里程碑,其中包括在未用藥2型糖尿病患者中開展的多扎格列艾汀單藥治療三期臨床試驗SEED(HMM0301),和在二甲雙胍足量治療失效的2型糖尿病患者中開展的二甲雙胍聯合用藥臨床試驗DAWN(HMM0302)。臨床研究資料表明,在相應治療週期內,多扎格列艾汀展現出了顯著穩定療效和安全性。
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