HMS1005
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华领医药(02552)在美国启动第二代GKA的Ⅰb期临床试验并完成首例受试者入组
Xin Lang Cai Jing· 2025-12-10 01:44
Group 1 - The core viewpoint of the news is that HuaLing Pharmaceutical has successfully completed the first dosing of its second-generation glucose kinase activator (GKA) HMS1005 in a Phase Ib multiple ascending dose (MAD) trial in the United States, marking a significant step in expanding its presence in the overseas diabetes market [1][2] - HMS1005 is designed as a novel molecular entity with improved physicochemical properties, featuring a sustained-release formulation that allows for once-daily dosing, enhancing patient convenience and potentially improving adherence to treatment [1] - The successful completion of the Phase Ib clinical trial will lead the company to seek partnerships for the global market development of HMS1005, further solidifying its leading position in the global GKA sector [1] Group 2 - The CEO of HuaLing Pharmaceutical, Dr. Chen Li, emphasized that the initiation of the Phase Ib clinical trial in the U.S. is a critical step in leading the innovation of diabetes drug development and overseas market expansion [2] - The company aims to validate the safety and tolerability of the second-generation GKA through robust trial design and strong R&D execution, laying a solid foundation for future clinical development [2] - HuaLing Pharmaceutical is committed to exploring better treatment options while deepening its existing product market, with plans to continue advancing more innovative drugs and global outreach to provide new treatment hopes for patients with type 2 diabetes [2]
华领医药在美国启动第二代GKA的Ⅰb期临床试验并完成首例受试者入组
Zhi Tong Cai Jing· 2025-12-10 01:40
Core Insights - The company has successfully completed the first dosing of its second-generation glucose kinase activator (GKA) HMS1005 in a Phase Ib multiple ascending dose (MAD) trial in the United States, marking a significant step in its expansion into the overseas diabetes market [1][2] - HMS1005 is designed as a novel molecular entity with improved physicochemical properties, featuring a sustained-release formulation that allows for once-daily dosing, enhancing patient convenience and potentially improving adherence to treatment [1] - Following the successful completion of the Phase Ib trial, the company plans to seek partners to advance the global market development of HMS1005, further solidifying its leading position in the global GKA sector [1] Group 1 - The Phase Ib clinical trial is a critical step for the company in leading the development of innovative diabetes drugs and expanding into overseas markets [2] - The company emphasizes its commitment to the innovation concept of "repairing sensing and reshaping homeostasis," while continuing to explore better treatment options for type 2 diabetes patients [2] - The successful results from previous single ascending dose (SAD) trials have validated the feasibility of a once-daily oral dosing regimen for treating type 2 diabetes patients with obesity [1]
华领医药-B(02552.HK)第二代“GKA”美国Ib期试验首名患者成功给药
Ge Long Hui· 2025-12-09 11:56
Core Viewpoint - The company has initiated a multi-dose escalation Phase Ib trial for its second-generation glucose kinase activator (GKA), HMS1005, in the United States, marking a significant step in its development for treating type 2 diabetes (T2D) [1] Group 1: Trial Details - The Phase Ib trial is a randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of HMS1005 in T2D subjects [1] - The study will assess pharmacodynamic markers such as blood glucose, insulin, C-peptide, GLP-1, and glucagon in both fasting and fed states, along with continuous glucose monitoring (CGM) to explore the mechanism and effects of HMS1005 [1] Group 2: Product Characteristics - HMS1005 is a new molecular entity with improved physicochemical properties, designed as a sustained-release formulation to allow once-daily dosing, enhancing patient convenience and prolonging the drug's duration in the intestine [1] - The drug aims to improve the repair of GLP-1 secretion deficiencies in patients [1] Group 3: Future Plans - Upon successful completion of the Phase Ib trial, the company plans to seek partnerships for the global development of HMS1005 [1]