Core Viewpoint - The commercialization process of the core product HTD1801 is expected to accelerate within the year, with positive Phase III trial data for treating type 2 diabetes, showcasing significant differentiation and multi-effect advantages [1][2]. Product Development - HTD1801 has successfully completed two Phase III clinical trials for type 2 diabetes patients in China, with data readouts completed and a head-to-head trial against Dapagliflozin expected to be announced by December 2025 [2]. - The product is in the final sprint of development and is anticipated to enter the New Drug Application (NDA) stage by the end of 2025 [2]. Product Features and Market Potential - HTD1801 is a globally innovative oral anti-inflammatory and metabolic modulator, granted two Fast Track designations by the FDA, and operates through a unique dual mechanism that activates AMPK and inhibits NLRP3 [3]. - The product shows broad efficacy in improving blood glucose metabolism, kidney protection, heart protection, liver protection, anti-inflammation, and weight loss, distinguishing it from other diabetes treatments [3]. - There is a significant unmet clinical need in the treatment of cardio-renal metabolic (CKM) diseases, and HTD1801 has the potential to become a cornerstone therapy in this area, indicating a vast market opportunity [3]. Clinical Trial Results - Phase III clinical data indicates that HTD1801 can significantly and clinically meaningfully reduce HbA1c levels by -1.1% to -1.3%, effectively lowering fasting and postprandial blood glucose levels and improving insulin resistance [4]. - HTD1801 demonstrates superior HbA1c reduction compared to Dapagliflozin, with a higher proportion of patients achieving HbA1c < 7% [4]. - The product also shows significant improvements in cardiovascular metabolic indicators such as LDL-C and non-HDL-C compared to Dapagliflozin, highlighting its competitive advantages [4]. Chronic Kidney Disease (CKD) Application - HTD1801 has shown potential in improving eGFR levels in chronic kidney disease (CKD) treatment, with clinical data indicating its ability to improve eGFR changes in early-stage patients [5]. - In patients with mild renal impairment, HTD1801 significantly improved eGFR compared to placebo, suggesting its potential for restoring kidney function [5].