Hua Medicine (HUA MEDICINE-B; 02552) presented a series of significant research findings on its first-in-class glucose kinase activator (GKA) dorzagliatin at the 86th American Diabetes Association (ADA) Scientific Sessions. The results, covering synergistic drug combinations, large-scale real-world evidence, and AI-powered precision diagnostic tools, further solidify the company's global leadership in the field of glucose homeostasis research.
The findings further validate the mechanism of dorzagliatin in restoring glucose homeostasis at its source and highlight its broad potential in complex metabolic diseases such as type 2 diabetes, metabolic dysfunction-associated steatotic liver disease (MASLD), obesity, and MODY2. Dorzagliatin targets glucokinase, repairing impaired GK function and expression in type 2 diabetes patients to achieve multi-organ coordination between the pancreas, liver, and intestines, thereby improving glucose homeostasis and offering a novel treatment paradigm for diabetes and metabolic disorders.
Building on this mechanism, the company presented data at ADA showing that combining dorzagliatin with oral small-molecule GLP-1 receptor agonists, THRβ agonists, and pan-PPAR agonists can produce synergistic effects. This combination therapy holds promise for benefits beyond glucose control, including weight loss, lipid regulation, uric acid reduction, and improved insulin sensitivity. Notably, an oral presentation confirmed for the first time a synergistic effect between dorzagliatin and the oral small-molecule GLP-1 receptor agonist orforglipron.
Animal model studies demonstrated a triple synergistic effect on glucose control, weight loss, and lipid regulation. The combination's glucose-lowering effect was significantly better than either drug alone, with a low-dose combination achieving results comparable to a high-dose monotherapy, while preserving weight loss and lipid benefits. Furthermore, by reducing the required dose of the GLP-1 receptor agonist, the combination significantly decreased gastrointestinal side effects like nausea and vomiting, potentially improving long-term patient adherence. This research offers a more effective, tolerable, and differentiated oral combination therapy for patients with type 2 diabetes and obesity.
Hua Medicine also presented two additional combination studies via posters. One study combined dorzagliatin with the THRβ agonist resmetirom, showing synergistic improvement in metabolism and liver protection in a MASLD mouse model, optimizing glucose, lipids, and uric acid while reducing liver fibrosis, indicating strong clinical potential for MASLD and T2D. The other study combined dorzagliatin with the pan-PPAR agonist chiglitazar, demonstrating significant synergistic metabolic benefits in a mouse model of MASLD with comorbid obesity and diabetes, including synergistic glucose lowering, improved glucose tolerance, insulin resistance, beta-cell function, and increased HDL cholesterol.
These two studies together validate that dorzagliatin, leveraging its advantage in restoring metabolic homeostasis, can work synergistically with drugs targeting various pathways, broadening its therapeutic application in pan-metabolic diseases like obesity and MASLD. At the ADA conference, the company also released more core data from the large-scale post-marketing real-world "BLOOM Study." This study enrolled 2,024 type 2 diabetes patients with a 52-week follow-up.
The results showed no drug-related serious adverse events, with a clinically significant hypoglycemia rate of less than 1%. Patients experienced a significant overall reduction in HbA1c, with a decrease of 1.11% for those with a baseline HbA1c ≥8%. Robust glucose control was achieved whether dorzagliatin was used as monotherapy or in combination with metformin, SGLT-2 inhibitors, GLP-1 receptor agonists, or insulin. Another interim study involving 255 patients with long disease duration and multi-drug regimens (including insulin) confirmed that dorzagliatin significantly increased Time in Range (TIR) for patients with severe glycemic dysregulation and improved islet beta-cell function.
Additionally, centered on the core glucokinase (GK) mechanism, Hua Medicine is deeply integrating artificial intelligence (AI), large language models (LLM), and clinical big data to develop AI tools covering efficacy prediction, diabetes remission prediction, monogenic diabetes classification, and medical education. Among these, GK Charger is an LLM-based medical education platform that translates complex scientific knowledge into evidence-based content for clinicians and patients.
An efficacy prediction model built on dorzagliatin clinical trial data can forecast a patient's HbA1c response rate and diabetes remission likelihood. The GK Mutation AI Analysis system, leveraging a database of nearly a thousand GK mutations, can complete genetic diagnosis and drug response prediction for MODY2 within seconds with 90% accuracy. The company also announced an innovative detection technology applicable to kit development.
In academic recognition, Feng Lingge, Senior Director of Research and Discovery Technology at Hua Medicine, received the ADA Young Investigator Abstract Award. This not only reflects the scientific quality of the company's research but also underscores global academic recognition for its pioneering work in innovative drug development and AI-enabled diabetes diagnosis and treatment. The comprehensive series of results confirm the unique mechanism and broad clinical application prospects of dorzagliatin as a first-in-class GKA, potentially accelerating its expansion into indications for metabolic diseases like obesity, MASLD, and MODY2.