Core Insights - Junsheng Tai Pharmaceutical (2511.HK) announced positive results from the Phase III clinical trial (HARMONY) of HTD1801 in patients with Type 2 Diabetes Mellitus (T2DM), achieving its primary endpoint and outperforming Dapagliflozin in several key cardiovascular metabolic indicators [1][2] Group 1: Clinical Trial Results - HTD1801 demonstrated superior performance compared to SGLT2 inhibitors by simultaneously regulating metabolic and inflammatory pathways, targeting the core pathological mechanisms of T2DM more precisely [2] - HARMONY is the third Phase III trial to yield positive results for HTD1801, following SYMPHONY-1 and SYMPHONY-2, further validating its strong potential as a foundational treatment for cardiorenal metabolic diseases (CKM) [2] Group 2: Future Plans and Statements - Junsheng Tai Pharmaceutical plans to initiate a New Drug Application (NDA) for the HTD1801 project within the year [2] - Dr. Li Ping Liu, the founder, chairman, and CEO of Junsheng Tai Pharmaceutical, stated that the data readout from the HARMONY study marks a key milestone in the global development process of HTD1801, highlighting its innovative "one drug, multiple effects" characteristics and potential to complement or even surpass the treatment boundaries of SGLT2 inhibitors for T2DM patients [2]
君圣泰医药HTD1801与达格列净的头对头III期临床试验结果优效 计划年内启动新药上市申请