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[News] Hua Medicine Initiated Phase Ib Clinical Trial of 2nd Gen GKA in the U.S. and Completed Enrollment of First Patient
December 9, 2025 - China, Shanghai
Hua Medicine ("the Company", Hong Kong Stock Exchange Stock Code: 2552.HK) announced that the multiple-ascending dose (MAD) Phase Ib clinical trial of HMS1005 (formerly known as HM-002-1005), a second-generation glucokinase activator (GKA) independently developed by the Company, has successfully completed the first patient dosing in the United States. This marks another progress for Hua Medicine in advancing the expansion of the overseas diabetes market, continuing to lead the new global development path of GKA.
This randomized, double-blinded, placebo-controlled, multi-dose escalation study aims to evaluate the safety, tolerability, pharmacokinetic (PK) profiles and pharmacodynamic (PD) responses of multiple ascending doses of HMS1005 in participants with Type 2 diabetes (T2D) in the United States, and to explore the effective dosage range as well as the exposure-response relationship. In this study, the mechanism and effects of HMS1005 will also be further explored by evaluating PD biomarkers, including glucose, insulin, C-peptide, GLP-1 and glucagon etc. Under the fasting and fed conditions and monitoring glucose fluctuation via continuous glucose monitor (CGM).
HMS1005 is a new molecular entity with improved physical-chemical properties. It was designed as an extended-release formulation to allow for once daily administration for added convenience for patients, as well as increasing the duration of the drug in the intestinal organs leading to the enhanced repair of deficient GLP-1 secretion in patients. HMS1005 is expected to prolong the drug's action time in the human body, improve patient medication adherence, and provide the possibility of achieving stable blood glucose control throughout the day.
Previously, the Company successfully completed and announced the positive results of our single-ascending dose study in the United States of HMS1005, in which we validated the feasibility of our once-daily oral therapy for T2D patients with obesity.
Upon successful completion of the Phase Ib study, the Company intends to seek partners to develop HMS1005 for the global markets.
Dr. Li Chen, Founder and CEO of Hua Medicine, stated: "The initiation of the Phase Ib clinical trial in the United States is a crucial step for Hua Medicine in leading the R&D of innovative diabetes drugs and the layout of overseas markets. With a mature study design and strong R&D execution capabilities, we look forward to fully verifying the safety and tolerability of the second-generation GKA, laying a solid foundation for subsequent clinical development. Adhering to the innovative concept of 'repairing the sensor and restoring the homeostasis', Hua Medicine will continue to explore more high-quality treatment options while deepening the existing product market. In the future, we will further promote the R&D and global layout of more innovative drugs, bringing new treatment hopes to T2D patients worldwide."
About Hua Medicine
Hua Medicine (The "Company") is an innovative drug development and commercialization company based in Shanghai, China, with companies in the United States and Hong Kong. Hua Medicine focuses on developing novel therapies for patients with unmet medical needs worldwide. Based on global resources, Hua Medicine teams up with global high-calibre people to develop breakthrough technologies and products, which contribute to innovation in diabetes care. Hua Medicine's cornerstone product HuaTangNing (dorzagliatin tablets), targets the glucose sensor glucokinase, restores glucose sensitivity in T2D patients, and stabilizes imbalances in blood glucose levels in patients. HuaTangNing was approved by the National Medical Products Administration (NMPA) of China on September 30th, 2022. It can be used alone or in combination with metformin for adult T2D patients. For patients with chronic kidney disease (CKD), no dose adjustment is required. It is an oral hypoglycemic drug that can be used for patients with Type 2 diabetes with renal function impairment.
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