Hua Medicine Ltd. has received marketing approval from China's NMPA for its glucokinase activator (GKA), Huatangning (dorzagliatin tablets), for two indications: as a monotherapy to improve blood glucose control for drug-naïve type 2 diabetes patients and in combination with metformin in metformin-tolerated type 2 diabetes patients to control blood glucose level. It marks the first GKA drug to gain approval in any market, according to Hua.
Hua Medicine Ltd. has received marketing approval from China's NMPA for its glucokinase activator (GKA), Huatangning (dorzagliatin tablets), for two indications: as a monotherapy to improve blood glucose control for drug-naïve type 2 diabetes patients and in combination with metformin in metformin-tolerated type 2 diabetes patients to control blood glucose level. It marks the first GKA drug to gain approval in any market, according to Hua.
BEIJING – Diabetes-focused Hua Medicine (Shanghai) Ltd. became the first drugmaker to reveal phase III data of a glucokinase activator (GKA) designed to treat type 2 diabetes. On June 18, it said its first-in-class GKA, dorzagliatin, showed sustained efficacy and safety for the 52-week treatment period with reductions in HbA1c levels in a completed phase III trial as a monotherapy.