Chiglitazar Sodium (trade name: Bilessglu®) is a novel molecular entity drug with a unique mechanism discovered exclusively by the company. It is the world's first PPAR pan-agonist and belongs to the insulin sensitizer class. Chiglitazar Sodium is an achievement of China's National 863 Program and the "Major New Drug Innovation" initiative.

Chiglitazar Sodium is a balanced agonist of all three PPAR subtypes, helping restore glucose, lipid, and energy metabolic homeostasis Specifically: 1) PPARγ activation enhances insulin sensitivity, reduces cholesterol deposition and vascular inflammation, and improves insulin resistance and glucose metabolism; 2) PPARα activation lowers circulating free fatty acids and triglycerides, increases high-density lipoprotein (HDL) levels, promotes fatty acid oxidation, and reduces fat accumulation in tissues; and 3) PPARδ activation promotes the redistribution of triglycerides and cholesterol among tissues, helping regulate energy metabolism and fat distribution.

The drug is approved for use both as a monotherapy and in combination with metformin for the treatment of type 2 diabetes mellitus, and it has been included in the National Reimbursement Drug List. To date, it has been recommended in 14 authoritative guidelines and consensus statements. In 2026, it was newly included in the Clinical Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus in the Elderly in China, the Expert Consensus on the Co-management of "Four Highs" in Primary Care Patients with Diabetes, and the Clinical Expert Consensus on the Assessment and Protection of Pancreatic β-Cell Function in Type 2 Diabetes Mellitus. The Company also collaborated with JD Health to release the White Paper on the Current Status and Future of Comprehensive Insulin Resistance Management in China (2025), promoting a shift in chronic disease management from glycemic control alone to comprehensive metabolic management. In terms of formulation development, the clinical trial application for the combination product Chiglitazar Sodium/Metformin Extended-Release Tablets was approved in March 2026, and registration studies are now underway.Meanwhile, research on Chiglitazar Sodium is expanding into diabetic complications and earlier stages of disease.

Figure Potential Mechanisms of Action of Chiglitazar Sodium 

Commercialization Status in China:

• In October 2021, Chiglitazar Sodium was approved for the treatment of type 2 diabetes (T2DM).
• In March 2023, Chiglitazar Sodium was included in the National Medical Insurance Drug List.
• In July 2024, Chiglitazar Sodium in combination with metformin was approved for the treatment of patients with type 2 diabetes mellitus inadequately controlled by metformin alone, providing a new option for combination therapy in type 2 diabetes patients.
• In November 2024, Chiglitazar Sodium was renewed at the original price in the National Medical Insurance Drug List.

Clinical Evidence Supporting the Co-management of Diabetes and Liver Disease::

• MASH Phase II primary endpoint: In March 2024, a randomized, double-blind, placebo-controlled Phase II clinical trial evaluating Chiglitazar Sodium monotherapy for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) met its primary efficacy endpoint, demonstrating favorable efficacy.
• AASLD oral presentation: In November 2024, the study results were selected for an oral presentation at the 75th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), where Professor You Hong of Beijing Friendship Hospital, Capital Medical University, presented the findings.
• APASL oral presentation: In March 2025, at the Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL), Professor Zang Shufei of Shanghai Fifth People's Hospital presented new clinical data on Chiglitazar Sodium in patients with type 2 diabetes mellitus complicated by MASH. The results showed favorable efficacy and safety with the 48 mg dose in this high-risk population.
• Real-world study published: In June 2025, a real-world study evaluating the effects of Chiglitazar Sodium in patients with type 2 diabetes mellitus and metabolic dysfunction-associated fatty liver disease was published in Diabetes & Metabolism, the official journal of the French Diabetes Society. The study found that Chiglitazar Sodium significantly reduced controlled attenuation parameter (CAP) values, a key indicator of hepatic steatosis, supporting its potential for the integrated management of both glycemic control and liver disease.
• Phase II results published in Hepatology: In August 2025, results from the Phase II clinical trial of Chiglitazar Sodium monotherapy for MASH were published in Hepatology, a leading international journal in liver disease. After 18 weeks of treatment, liver fat content decreased by 40%, and more than 70% of patients had liver enzyme levels return to the normal range.
• PRECISE study initiated: In September 2025, the PRECISE study of Chiglitazar Sodium was initiated to explore earlier intervention in patients with prediabetes.
• EASD oral presentation: In September 2025, a pivotal study on PPARs was presented orally at the 2025 Annual Meeting of the European Association for the Study of Diabetes (EASD), providing new clinical evidence for the treatment of diabetic foot ulcers.

Multiple clinical studies have demonstrated the efficacy and safety of Chiglitazar Sodium in patients with type 2 diabetes mellitus and fatty liver disease, further strengthening the clinical evidence supporting its use across both conditions. These findings support the continued development of Chiglitazar Sodium as a potential foundational therapy for the comprehensive management of metabolic diseases.