Core Insights - Junsheng Tai Pharmaceutical-B (02511.HK) announced positive results from the Phase III clinical trial (HARMONY) of HTD1801 in patients with Type 2 Diabetes Mellitus (T2DM), achieving the primary endpoint and outperforming Dapagliflozin in several key cardiovascular metabolic indicators [1][2] Group 1: Clinical Trial Results - HARMONY (NCT06415773) is a randomized, double-blind, positive drug-controlled Phase III clinical study involving 369 participants, aimed at evaluating the efficacy and safety of HTD1801 compared to Dapagliflozin in adult T2DM patients with inadequate blood sugar control after Metformin treatment [1] - The primary endpoint was the change in HbA1c from baseline after 24 weeks of treatment, with HTD1801 showing a least squares (LS) mean change of -1.12% compared to -0.93% for Dapagliflozin, resulting in a LS mean difference of -0.20% (95% CI: -0.37 to -0.03; P < 0.001) [1][2] Group 2: Secondary Endpoints and Safety - HTD1801 significantly outperformed Dapagliflozin in reducing LDL-C and non-HDL-C, with a lower proportion of patients requiring additional or intensified statin therapy compared to the Dapagliflozin group [2] - HTD1801 also showed superior improvement in multiple cardiovascular metabolic indicators, including a higher percentage of patients achieving the HbA1c < 7.0% control target and a greater reduction in Lp(a) levels [2] - The safety profile of HTD1801 was favorable, with a serious adverse event rate of 3.8% (compared to 4.4% for Dapagliflozin), and the most common adverse events were mild to moderate gastrointestinal issues, with no severe hypoglycemic events reported [2] Group 3: Future Prospects - Overall, HTD1801 targets the core pathological mechanisms of T2DM more precisely by simultaneously regulating metabolic and inflammatory pathways, potentially offering comprehensive clinical benefits for T2DM patients [2] - Following the positive results from the SYMPHONY-1 and SYMPHONY-2 trials, HARMONY marks the third successful Phase III trial for HTD1801, reinforcing its strong potential as a foundational treatment for cardiorenal metabolic diseases (CKM) [2] - Junsheng Tai Pharmaceutical plans to initiate a New Drug Application (NDA) for the HTD1801 project within this year [2]
君圣泰医药-B(02511.HK)公布HTD1801与达格列净的头对头III期临床研究结果 展现控糖优势及心血管代谢优效获益