HuaTangNing (dorzagliatin) / Hua Medicine - LARVOL DELTA

Synergistic Effects of Dorzagliatin and Orforglipron on Glycemic Control and Adiposity in DIO Mice (ADA 2026) - "Available on Friday, May 29, 2026 at 12:00am CDT."

Preclinical • Metabolic Disorders • Obesity

Safety and Efficacy of Dorzagliatin in Patients with Type 2 Diabetes under Real-World Clinical Practice: Preliminary Results from a Large-Scale Post-Marketing Study (ADA 2026) - "Available on Friday, May 29, 2026 at 12:00am CDT."

Clinical • P4 data • Real-world • Real-world evidence • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Synergistic Metabolic and Hepatic Benefits of Dorzagliatin and Resmetirom in MASLD Mice (ADA 2026) - "Available on Friday, May 29, 2026 at 12:00am CDT."

Preclinical • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease

Development of Preliminary Predictive Models for Dorzagliatin Treatment Response and Diabetes Remission in Type 2 Diabetes: A Focus on Personalized Medicine (ADA 2026) - "Available on Friday, May 29, 2026 at 12:00am CDT."

Clinical • Predictive model • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Lipid-lowering and glucose-lowering drug targets differentially modulate antipsychotic treatment efficacy in schizophrenia. (PubMed, Cell Rep Med) - "Genetically proxied proteomics analysis provides further functional validation for the identified target-outcome associations. Our findings suggest volanesorsen/olezarsen as potential adjunctive candidates; dorzagliatin warrants prudence in schizophrenia with metabolic disturbance."

Journal • CNS Disorders • Diabetes • Dyslipidemia • Metabolic Disorders • Psychiatry • Schizophrenia

EFFECTS OF DORZAGLIATIN A NOVEL GLUCOKINASE ACTIVATOR , INSULIN GLARGINE AND METFORMIN ON NOCTURNAL GLUCOSE PRODUCTION IN TYPE 2 DIABETES (ATTD 2026) - "Both DG and IG show effects on early nocturnal EGP by reducing rates of GGL overnight with a smaller contribution of GNG. M used as monotherapy did not provide adequate lowering of nocturnal EGP. DG and IG combination may target GGL and GNG overnight thereby reducing nighttime glucose production."

Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Hua Medicine…announced…that its global first-in-class glucokinase activator (GKA) dorzagliatin (Trade name: MYHOMSIS) has been approved for marketing by the Pharmaceutical Service of the Department of Health of the Hong Kong Special Administrative Region of China for the treatment of Type 2 diabetes in adults. (The Manila Times)

Approval • Type 2 Diabetes Mellitus

Dorzagliatin shows potential in preventing cognitive impairment in diabetes: evidence from Mendelian randomization analysis and animal study. (PubMed, Front Endocrinol (Lausanne)) - "Maintaining glucose homeostasis directly regulates insulin pathway and glucose uptake, as well as enhances neurotransmission processes in the hippocampus. These findings not only highlight dorzagliatin as a promising therapeutic option for preventing diabetes-associated cognitive decline but also provide critical mechanistic insights into the role of GK modulated glucose homeostasis in preserving brain function, offering a potential translational strategy for clinical intervention."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • IR

Research of the efficacy and safety of dorzagliatin on latent autoimmune diabetes in adults(LADA) (ChiCTR) - P=N/A | N=60 | Recruiting | Sponsor: The First Affiliated Hospital of Bengbu Medical University; The First Affiliated Hospital of Bengbu Medical University | -> Recruiting

Enrollment open • Diabetes • Immunology • Metabolic Disorders

Efficacy and safety of Dorzagliatin in real-world populations with type 2 diabetes: a China multicenter retrospective study (EASTERN Study） (ChiCTR) - P4 | N=800 | Not yet recruiting | Sponsor: Shanghai General Hospital; Shanghai General Hospital

New P4 trial • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

TAT-PBX1 Reverses Hyperglycemia Through β-Cell Regeneration and Functional Restoration in an STZ-Induced Diabetic Model. (PubMed, Pharmaceuticals (Basel)) - "Its protective effects were assessed in STZ-treated MIN6 β cells and in a mouse model of STZ-induced diabetes, with the glucokinase (GK) activator dorzagliatin included as a positive control... TAT-PBX1 restores β-cell function through coordinated protection of cellular metabolism and insulin signaling, leading to improved β-cell survival, glucose responsiveness, and regenerative capacity. These findings support TAT-PBX1 as a promising molecular strategy for β-cell-protective and β-cell-restorative diabetes therapy."

Journal • Diabetes • Metabolic Disorders • PARP1 • PBX1 • PDX1

Recent progress of remission in type 2 diabetes. (PubMed, Ther Adv Endocrinol Metab) - "This review aims to summarize and update the latest clinical evidence and research advancements regarding remission strategies for T2DM, primarily including intensive lifestyle interventions, metabolic surgery, short-term intensive insulin therapy, and non-insulin hypoglycemic drugs (e.g., glucagon-like peptide-1 receptor agonists and dorzagliatin) treatments, to guide the selection of appropriate treatment modalities for diverse patient populations. Additionally, the durability of sustained diabetes remission is briefly discussed."

Journal • Review • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Modelling the effects of human SUR1 R1420H variation on insulin secretory function using isogenic iPSC-derived pancreatic islets. (PubMed, Diabetologia) - "A SUR1 R1420H variant identified in an Indigenous American population causes hyperinsulinaemia in homozygous immature SC-islets during basal conditions and these SC-islets fail to achieve glucose responsiveness after maturation. In the heterozygous state, modest hyperinsulinaemia is observed in immature SC-islets, which after maturation have significantly lower glucose responsiveness. These results demonstrate that SUR1 R1420H is a KATP channel LoF variation and suggest that a lower insulin secretory response during adulthood is the cause of the higher type 2 diabetes risk in individuals heterozygous for this variation. We also show that the isogenic iPSC-based platform can be used to test therapeutic agents to treat HHI in infants homozygous for LoF KATP channels and screen for drugs that can improve glucose-responsive insulin secretion in adult heterozygous carriers."

Journal • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Case Report: Exogenous insulin antibody syndrome complicated with chronic renal failure and long-term history of type 2 diabetes: report of two cases. (PubMed, Front Endocrinol (Lausanne)) - "In both patients, glycemic fluctuations resolved following insulin discontinuation and the initiation of dorzagliatin, confirming the diagnosis of EIAS. In type 2 diabetic patients with unexplained hypoglycemic and hyperglycemic episodes with a history of exogenous insulin use, pancreatic function and the autoimmune antibody spectrum should be comprehensively evaluated to rule out EIAS and provide an accurate diagnosis and guide treatment strategies."

Journal • Chronic Kidney Disease • Diabetes • Hypoglycemia • Immunology • Metabolic Disorders • Renal Disease • Type 2 Diabetes Mellitus

Dorzagliatin in Pancreatic Insufficient Cystic Fibrosis (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: University of Pennsylvania | Not yet recruiting ➔ Recruiting

Enrollment open • Cystic Fibrosis • Diabetes • Genetic Disorders • Immunology • Metabolic Disorders • Pulmonary Disease • Respiratory Diseases

Additive Effects of Dorzagliatin and Glucagon-Like Peptide-1 Receptor Agonism in a Novel Mouse Model of GCK-MODY and in Obese db/db Mice. (PubMed, Diabetes) - "Dorzagliatin potentiates the effects of glucagon-like receptor-1 receptor activation sex dependently in heterozygous Gck mice and in obese hyperglycemic db/db mice. Combined use of these drugs may be useful in some forms of GCK-MODY and in obesity-related type 2 diabetes."

Journal • Preclinical • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Hua Medicine…announced that the Department of Health of the Hong Kong Special Administrative Region of China accepted a New Drug Application (NDA) for dorzagliatin, the world’s first glucokinase activator (GKA) approved for the treatment of Type 2 diabetes (T2D). (The Globe and Mail) - "Results from two Phase III registration trials in China demonstrated that dorzagliatin significantly and sustainably lowered HbA1c levels, improved pancreatic β-cell function, and reduced insulin resistance, all while showing strong safety and tolerability."

Filing • Type 2 Diabetes Mellitus

Genotype-Phenotype Discrepancies in Family Members With a Novel Glucokinase Mutation: Insights Into GCK-MODY and Its Interplay With Insulin Resistance. (PubMed, Diabetes) - "Both dorzagliatin and liraglutide improved glucose tolerance and insulin secretion in mutant mice. We found that GCK-Q26L is a pathogenic mutation leading to GCK-MODY, with severity modulated by polygenic risk score for insulin resistance and type 2 diabetes. These findings not only expand the list of GCK-MODY causing mutations but also highlight the importance of polygenic backgrounds in the clinical presentation and management of monogenic diabetes."

Journal • Diabetes • Dyslipidemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Dorzagliatin enhances GLP-1 secretion by restoring the function of intestinal L-cells (EASD 2025) - "Our study reveals the unique ability of dorzagliatin to promote the synthesis of GLP-1 in intestinal L-cells, while TTP399 lacks this effect. The observed upregulation of Gcg and Pcsk1 genes and increased L-cell abundance further demonstrate the role of dorzagliatin in restoring L-cell function, underscoring its superior therapeutic potential for T2D compared with other GKA, such as TTP399."

Late-breaking abstract • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus • GCG • PCSK1

Effects of Dorzagliatin, a Glucokinase Activator, on α- and β-Cell Function in Individuals With Impaired and Normal Glucose Tolerance. (PubMed, Diabetes) - "With increasing glucose, plasma glucagon and total GLP-1 levels declined progressively. A modest to moderate positive correlation between glucagon and total GLP-1 was observed under both dorzagliatin and placebo treatments."

Journal • Diabetes • Metabolic Disorders

Business Highlights and Operational Progress (The Manila Times) - "Effective from January 1, 2025, the Company terminated its exclusive promotion service agreement with Bayer and fully took over the commercialization of HuaTangNing in China. During the Reporting Period, with unit prices remaining consistent with the same period in 2024, sales of HuaTangNing reached 1,764,000 packs, a year-on-year increase of 108%. Net sales reached RMB217.4 million, a year-on-year increase of 112%."

Commercial • Type 2 Diabetes Mellitus

An innovative method for simultaneous separation and determination of monosaccharide and sugar alcohol isomers associated with glycometabolism in beagle plasma using gas chromatography-mass spectrometry. (PubMed, Anal Chim Acta) - "This method solves the problems of multiple peaks after derivatization and frequent co-elution of analytes in previous analytical methods, significantly enhances derivatization efficiency of ketoses, which provides a promising approach for simultaneous analysis of aldose, ketose, and sugar alcohol. It offers new insights into a more comprehensive research on glycometabolism rather than merely focusing on glucose."

Journal • Metabolic Disorders

In Vivo PK-PD and Drug-Drug Interaction Study of Dorzagliatin for the Management of PI3Kα Inhibitor-Induced Hyperglycemia. (PubMed, Pharmaceuticals (Basel)) - "Objectives: The anticancer effects of PI3Kα inhibitors (PI3Ki) are constrained by their hyperglycemic side effects, while the efficacy of conventional hypoglycemic agents, such as insulin, metformin, and SGLT-2 inhibitors, in mitigating PI3Ki-induced hyperglycemia remains suboptimal. Our findings indicate that the drug-drug interactions (DDIs) between dorzagliatin and multiple PI3Ki (including WX390 and BYL719) may partially account for the enhanced antitumor efficacy observed in the combination therapy group compared to PI3Ki monotherapy. This interaction may be explained by the inhibition of P-glycoprotein (P-gp) and the pharmacological mechanism of dorzagliatin regarding the activation of insulin regulation."

Journal • PK/PD data • Preclinical • Diabetes • Oncology • PIK3CA

Factors influencing the initial glycemic efficacy of dorzagliatin, a novel glucokinase activator, in type 2 diabetes. (PubMed, Endocrine) - "Blood glucose levels of T2DM patients during dorzagliatin initial treatment are positively correlated with diabetes duration, suggesting greater efficacy of dorzagliatin in patients with shorter disease duration. Metformin may enhance the glucose-lowering efficacy of dorzagliatin but also increase the risk of hypoglycemia. Furthermore, factors like baseline FPG, TC and AST also influence outcomes."

Journal • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Interim Analysis of a Real-World Study—Glucokinase Activator Dorzagliatin Demonstrates Improved Glycemic Homeostasis and β-Cell Function in T2DM (ADA 2025) - "Dorzagliatin significantly improves glycemic homeostasis and β-cell function in patients with T2DM. These findings support the therapeutic potential of GKAs in diabetes management. Longer-term follow-up will further elucidate its clinical utility."

Clinical • Late-breaking abstract • Real-world • Real-world evidence • Metabolic Disorders • Type 2 Diabetes Mellitus