Huatai Securities International has released a research report initiating coverage on HIGHTIDE-B (02511), assigning a "Buy (First-time)" rating with a six-month target price of HK$5.78. The firm highlights the accelerated commercialization timeline for HIGHTIDE-B's core product, HTD1801, and its promising Phase III trial data for type 2 diabetes (T2DM) treatment.
**Key Investment Highlights:**
1. **Commercialization Progress Expected to Accelerate in 2025** - Two Phase III clinical trials for HTD1801 in T2DM patients in China were successfully completed in October 2025, with 52-week data readouts. - Head-to-head Phase III trial data against dapagliflozin was released in December 2025. - The product is in the final development stage for T2DM and is expected to enter the New Drug Application (NDA) phase by year-end.
2. **HTD1801: A Multi-Target Therapy with Broad Market Potential** - HTD1801 is a first-in-class oral anti-inflammatory and metabolic regulator, granted two Fast Track designations by the U.S. FDA. - The drug employs a dual mechanism—activating AMPK while inhibiting NLRP3—to address cardiorenal metabolic (CKM) diseases comprehensively. - Beyond glycemic control, HTD1801 demonstrates efficacy in kidney protection, cardiovascular benefits, anti-inflammatory effects, and weight management. - Its multi-functional profile differentiates it from existing diabetes treatments and aligns with the industry trend toward multi-target therapies.
3. **Strong Phase III Data Supports Competitive Edge** - HTD1801 significantly reduced HbA1c (-1.1% to -1.3%) and improved fasting/postprandial glucose levels. - It also lowered LDL-C, non-HDL-C, and inflammatory markers (GGT, hs-CRP). - In head-to-head trials against dapagliflozin, HTD1801 showed superior HbA1c reduction and a higher proportion of patients achieving HbA1c <7%. - Cardiovascular metabolic indicators (LDL-C, non-HDL-C, Lp(a)) improved more markedly with HTD1801.
4. **Potential in Chronic Kidney Disease (CKD) Treatment** - Early data suggests HTD1801 may improve eGFR levels and restore renal function in mild CKD patients. - Unlike current CKD therapies that primarily slow eGFR decline, HTD1801 demonstrated positive eGFR slope trends in trials.
**Financial Projections & Valuation** - Revenue forecasts for 2025–2027: RMB 0/0/253 million. - The target price of HK$5.78 reflects a discounted cash flow (DCF) valuation and near-term catalysts.
**Risks:** - Delays in commercialization. - Pipeline setbacks. - Intensifying competition.
The report underscores HTD1801’s potential as a cornerstone CKM therapy, backed by robust clinical data and a clear path to market entry.