Core Insights - Company Junsheng Tai Pharmaceutical-B (02511) presented data on HTD1801 at the 58th American Society of Nephrology (ASN) annual meeting, highlighting its potential benefits for patients with mild renal impairment [1] - HTD1801 is a first-in-class anti-inflammatory metabolic modulator (AIMM) designed to address cardiorenal metabolic system diseases (CKM) through a dual mechanism of activating AMPK and inhibiting NLRP3 [1] Clinical Results - The clinical results indicate that HTD1801 significantly improves eGFR in patients with mild renal impairment compared to placebo, with a positive slope in eGFR during treatment [2] - In patients with hyperfiltration, HTD1801 was associated with a reduction in eGFR compared to placebo, suggesting its potential to promote the restoration of normal kidney function [2] - HTD1801 did not show adverse effects on blood pressure, blood sodium, or blood potassium levels [2] Study Design - The data presented is based on a pooled analysis from two Phase III randomized, double-blind, placebo-controlled clinical studies (SYMPHONY1 & 2; N=956) conducted in patients with type 2 diabetes (T2DM) [1] - The analysis included post-hoc evaluations of subgroups with mild renal impairment (baseline eGFR: 60-90 ml/min/1.73m²) and hyperfiltration (baseline eGFR ≥120 ml/min/1.73m²), focusing on eGFR changes as the primary endpoint [1]

Core Insights - The company presented data on HTD1801 at the 58th American Society of Nephrology (ASN) annual meeting, highlighting its potential kidney benefits in patients with mild renal impairment [1] - HTD1801 is a first-in-class anti-inflammatory metabolic modulator (AIMM) designed to address cardiorenal metabolic system diseases (CKM) through a dual mechanism of activating AMPK and inhibiting NLRP3 [1] - The data is based on a pooled analysis from two Phase III clinical studies (SYMPHONY 1 & 2; N=956) involving patients with type 2 diabetes (T2DM) [1] Summary by Category Clinical Results - In patients with mild renal impairment, HTD1801 significantly improved eGFR compared to placebo, with a positive slope in eGFR during treatment [2] - In patients with hyperfiltration, HTD1801 reduced eGFR compared to placebo, suggesting a potential to restore kidney function to normal levels [2] - HTD1801 did not show adverse effects on blood pressure, blood sodium, or blood potassium levels [2]

Core Viewpoint - The company announced promising clinical results for HTD1801, indicating its potential to improve kidney function in patients with mild renal impairment, showcasing significant health benefits for chronic kidney disease (CKD) patients [1][2]. Group 1: Clinical Data and Results - HTD1801 is a first-in-class anti-inflammatory metabolic modulator (AIMM) designed to address cardiorenal metabolic system diseases (CKM) by activating AMPK and inhibiting NLRP3 [1]. - The data presented is based on a pooled analysis from two Phase III randomized, double-blind, placebo-controlled studies (SYMPHONY 1 & 2; N=956) conducted in patients with type 2 diabetes (T2DM) [1]. - In patients with mild renal impairment (baseline eGFR: 60-90 ml/min/1.73m), HTD1801 significantly improved eGFR compared to placebo, with a positive slope observed during treatment [2]. - In patients with hyperfiltration (baseline eGFR ≥120 ml/min/1.73m), HTD1801 reduced eGFR compared to placebo, suggesting a potential to restore kidney function to normal levels [2]. Group 2: Safety Profile - HTD1801 did not show adverse effects on blood pressure, blood sodium, or blood potassium levels during the treatment period [2].

Core Insights - Junsheng Tai Pharmaceutical-B (02511) has successfully completed two Phase III clinical trials (SYMPHONY-1 and SYMPHONY-2) for HTD1801 in patients with Type 2 Diabetes Mellitus (T2DM), demonstrating positive efficacy and safety results over a 52-week period [1][2] Group 1: Clinical Trial Results - The 52-week data from the two Phase III clinical studies confirm the durability of HTD1801's efficacy, highlighting its long-term comprehensive clinical benefits for T2DM patients [1] - The proportion of patients achieving HbA1c <7.0% remained stable at week 52 during the double-blind period [1] - HTD1801 showed sustained efficacy in lipid reduction, with significant decreases in low-density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C) [1] Group 2: Inflammatory Markers and Cardiovascular Benefits - Long-term treatment with HTD1801 also led to a continuous reduction in inflammatory markers closely related to cardiovascular events and clinical outcomes in T2DM patients, including gamma-glutamyl transferase (GGT) and high-sensitivity C-reactive protein (hs-CRP) [1] Group 3: Safety and Tolerability - HTD1801 demonstrated good safety and tolerability during long-term treatment, consistent with double-blind results, indicating that extending the treatment period does not increase the types or severity of adverse events for patients [2]