Hinova Pharmaceuticals (SH:688302) Shang Hai Zheng Quan Bao·2025-11-04 21:29Core Viewpoint - Haichuang Pharmaceutical has completed the enrollment of the first participants in the Phase II clinical trial of HP515, a drug for treating Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH), with no similar products approved in the domestic market as of the announcement date [2][4]. Group 1: Drug Information - HP515 is an orally administered, highly selective THR-β agonist developed by the company, aimed at enhancing lipid metabolism in liver cells to improve MASH [3]. - The drug received approval from the National Medical Products Administration of China in August 2024 and from the U.S. Food and Drug Administration in September 2024 for the treatment of MASH [3]. Group 2: Clinical Trial Results - The Phase I clinical trial of HP515 showed expected results in safety, tolerability, pharmacokinetics, and pharmacodynamics, with a significant dose-dependent increase in SHBG (Sex Hormone Binding Globulin) observed [4]. - At the 80 mg dosage, SHBG increased by 176% after 14 days of treatment, indicating the pharmacological effect of HP515 through THR-β receptor activation [4]. - Multiple lipid indicators showed significant improvements, with LDL-C (Low-Density Lipoprotein Cholesterol) decreasing by 39%, TC (Total Cholesterol) by 28%, and ApoB (Apolipoprotein B) by 41% at the 80 mg dosage [4]. Group 3: Market Potential - The global MASH market is projected to reach $10.7 billion by 2025 and $32.2 billion by 2030, with a compound annual growth rate (CAGR) of 24.6% [8]. - The Chinese MASH drug market is expected to reach 3.2 billion RMB by 2025 and 35.5 billion RMB by 2030, with a CAGR of 61.4% [8]. Group 4: Related Research - The company is also conducting research on HP515 in combination with GLP-1R agonists for obesity, showing promising potential to enhance weight loss effects while preserving muscle mass [5].