HIGHTIDE-B(02511): The world's first anti-inflammatory metabolic regulator HTD1801 has completed Phase III clinical trials for Type 2 diabetes, demonstrating sustained benefits and safety advantages over 52 weeks.

HIGHTIDE-B (02511) announced that two Phase III clinical trials (SYMPHONY-1 and SYMPHONY-2) of HTD1801 in patients with type 2 diabetes mellitus (T2DM) have been successfully completed, with positive efficacy and safety results at 52 weeks (including open-label extension period (OLE)). The 52-week data from the two Phase III clinical studies have fully confirmed the durability of the efficacy of HTD1801, further highlighting its long-term comprehensive clinical benefits for patients with T2DM. Junshengtai Pharmaceuticals plans to submit a New Drug Application (NDA) for HTD1801 for the treatment of T2DM to the Center for Drug Evaluation of the National Medical Products Administration (NMPA) within this year. In both studies, the proportion of patients achieving target HbA1c levels (HbA1c <7.0%) remained stable at week 52. At the same time, the efficacy of HTD1801 in lowering lipid levels was also sustained long-term, with significant reductions in low-density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C). Long-term treatment with HTD1801 also led to sustained reductions in inflammatory markers closely related to cardiovascular events and clinical outcomes in T2DM patients, such as gamma-glutamyl transferase (GGT) and high-sensitivity C-reactive protein (hs-CRP). HTD1801 demonstrated good safety and tolerability in long-term treatment, consistent with the results of the double-blind phase. For patients receiving treatment with HTD1801, extending the treatment period did not increase the type or severity of adverse events.