Core Insights - The clinical trial HARMONY for HTD1801 in Type 2 Diabetes Mellitus (T2DM) patients has shown positive results, achieving its primary endpoint and outperforming Dapagliflozin in several key cardiovascular metabolic indicators [1][2] - HTD1801 targets the root causes of T2DM, providing comprehensive cardiovascular metabolic benefits [1] Summary by Sections Clinical Trial Results - HARMONY is a randomized, double-blind, positive drug-controlled Phase III clinical study involving 369 participants, assessing the efficacy and safety of HTD1801 compared to Dapagliflozin in adults with T2DM who have inadequate blood sugar control after Metformin treatment [1] - The primary endpoint was the change in HbA1c from baseline after 24 weeks of treatment, with HTD1801 showing a least squares (LS) mean change of -1.12% compared to -0.93% for Dapagliflozin (LS mean difference: -0.20%; 95% CI: -0.37 to -0.03; P < 0.001) [1] - HTD1801 also achieved multiple secondary endpoints, demonstrating superior reductions in LDL-C and non-HDL-C compared to Dapagliflozin, with a significantly lower proportion of patients requiring additional or intensified statin therapy [1] Safety and Tolerability - HTD1801 exhibited good safety and tolerability, with a serious adverse event rate of 3.8% (compared to 4.4% in the Dapagliflozin group) [2] - The most common adverse events in the HTD1801 group were mild to moderate gastrointestinal issues, with no severe hypoglycemic events reported [2] Future Prospects - HTD1801's ability to simultaneously regulate metabolic and inflammatory pathways positions it as a promising foundational treatment for chronic kidney and metabolic diseases (CKM) [2] - Following the positive outcomes of the SYMPHONY-1 and SYMPHONY-2 trials, HARMONY marks the third successful Phase III trial for HTD1801, reinforcing its potential [2] - The company plans to initiate a New Drug Application (NDA) for HTD1801 within the year [2]

Core Viewpoint - Cheng Yi Bio Cayman Limited has submitted a listing application to the Hong Kong Stock Exchange, with Jefferies, BofA Securities, and CICC as joint sponsors [1] Company Overview - Cheng Yi Bio is a clinical-stage global biotechnology company focused on developing next-generation oral small molecule drugs to address significant unmet medical needs in cardiovascular metabolic diseases and inflammatory diseases [4] - The company utilizes its proprietary TRANDD platform to create a product pipeline aimed at single-agent treatments and combination therapies for weight management (obesity/overweight), Metabolic Associated Steatotic Liver Disease (MASH), osteoarthritis (OA) pain, and other cardiovascular metabolic diseases [4] Product Pipeline - The company has developed an oral small molecule GLP-1 receptor agonist (GLP-1RA) ECC5004, which is expected to be a best-in-class therapy and the second oral small molecule GLP-1 receptor agonist to be launched globally [4] - ECC4703, an oral liver-targeting thyroid hormone receptor β (THR-β) full agonist, aims to be a best-in-class treatment for MASH and a first-in-class liver-targeting selective THR-β full agonist for weight management [4] - ECC0509, an oral small molecule inhibitor of SSAO (also known as VAP1), can be used in combination with GLP-1 receptor agonists to maximize its therapeutic potential [4] Competitive Landscape - The company faces potential competition from multinational pharmaceutical companies and other biotechnology or specialty pharmaceutical companies that are actively developing or have commercialized therapies targeting similar indications, including GLP-1 receptor agonists and THR-β agonists [5] - The company does not guarantee the successful development and commercialization of its core products or any pipeline products [5] Financial Overview - For the fiscal years 2023, 2024, and the first half of 2025, the company's revenues are projected to be approximately $36.06 million, $221.29 million, and $0.557 million, respectively [7] - The net losses for the same periods are estimated at approximately $52.23 million, $138.84 million, and $20.11 million, respectively [7] - The company has no internal production facilities as of September 30, 2025, and all production activities are conducted through partners, including contract development and manufacturing organizations (CDMOs) [5]