Sciwind Biosciences Co., Ltd. ("Sciwind"), a biopharmaceutical company focused on the discovery and development of innovative therapies for metabolic diseases, announced that China's National Medical Products Administration (NMPA) has approved ecnoglutide injection for glycemic control in adults with type 2 diabetes mellitus (T2DM), making it the world's first approved cAMP-biased GLP-1 receptor agonist.

The number of diabetes patients in China has been increasing steadily over the past decades, reaching approximately 148 million by 2024. Concurrently, the glucose-lowering strategy has evolved from solely managing hyperglycemia to emphasizing comprehensive, long-term patient benefits. As a cornerstone therapy for T2DM, GLP-1 receptor agonists (GLP-1RAs) have undergone continuous improvement, culminating in the development of "biased GLP-1RAs," with ecnoglutide serving as an example. This advancement marks a novel direction in diabetes management and has been cited in the Guideline for the Prevention and Treatment of Diabetes Mellitus in China (2024 Edition).

A novel cAMP-biased Mechanism

Ecnoglutide injection represents the world's first approved long-acting cAMP-biased glucagon-like peptide-1 (GLP-1) receptor agonist. In contrast to unbiased GLP-1 receptor therapies, ecnoglutide selectively activates cyclic adenosine monophosphate (cAMP) signaling pathways while minimizing β-arrestin recruitment. This signaling bias attenuates receptor desensitization, preserves receptor expression at the cell surface, and sustains prolonged therapeutic signaling. The unique biased mechanism of ecnoglutide is one of the key factors underlying its enhanced therapeutic efficacy and sustained metabolic benefits.

Comprehensive Benefits with Sustained Efficacy Over 52 Weeks

The approval of ecnoglutide injection is supported by its Phase III EECOH-1 and EECOH-2 clinical trials, which evaluated the efficacy and safety of the drug in Chinese participants with T2DM as monotherapy and in combination with metformin, respectively. Both pivotal trials demonstrated that ecnoglutide injection provides comprehensive clinical benefits, including effective glycemic control, significant weight reduction, and improvements in key metabolic parameters—with sustained efficacy over 52 weeks and a favorable safety and tolerability profile.

• EECOH-1 Study (published in Nature Communications): Using the treatment policy estimand, in adults with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise alone, both ecnoglutide doses resulted in a robust reduction in glycated hemoglobin (HbA_1c) compared with the placebo group after 24 weeks of treatment; importantly, the 1.2 mg dose group demonstrated a 2.43% reduction. Compared with the placebo group, both treatment groups had a significantly higher proportion of participants achieving HbA_1c＜5.7%, ≤6.5% and ＜7.0% at week 24, with 80.3% of participants in the ecnoglutide 1.2 mg dose group achieving an HbA_1c of ＜7.0%. These findings confirm that ecnoglutide effectively reduces HbA_1c, achieves higher proportions of participants reaching HbA_1c targets of <5.7%, ≤6.5% and <7.0% in a dose-dependent manner, and maintains stable efficacy for up to 52 weeks.
• EECOH-2 Study (published in The Lancet Diabetes & Endocrinology): Using the treatment policy estimand, in adults with T2DM inadequately controlled by metformin, ecnoglutide 0.6mg and 1.2mg exhibited greater reductions in HbA_1c compared with dulaglutide 1.5 mg. At week 32, the mean reduction in HbA_1c was 1.91% with ecnoglutide 0.6 mg. At week 52, the proportions of participants achieving HbA_1c targets of <7.0% and ≤6.5% in both ecnoglutide dose groups were significantly higher than those observed in the dulaglutide 1.5 mg group. Efficacy was maintained consistently throughout the 52-week treatment period. These data demonstrate that both ecnoglutide doses provide superior reductions in HbA_1c and higher proportions of participants reaching HbA_1c targets of <5.7%, ≤6.5% and <7.0% versus dulaglutide 1.5 mg.

Dr. Hai Pan, Founder and CEO of Sciwind Biosciences, stated, "As the world's first approved cAMP-biased GLP-1 receptor agonist, ecnoglutide's successful approval marks a major milestone for Sciwind. Building on this achievement, Sciwind will focus on scientific and technological innovation to bring this novel therapy and its broader pipeline of innovative treatments to benefit Chinese patients and hopefully, the patients around the world."

 Type 2 Diabetes

Type 2 Diabetes is a metabolic disorder characterized by chronic hyperglycaemia caused by defects in insulin secretion, insulin action, or both. Persistent hyperglycaemia can lead to long-term damage, dysfunction, and failure of multiple organs. By 2024, the number of diabetes patients in China had risen to 148 million. Diabetes treatment has evolved from insulin to metformin and GLP-1 receptor agonists, with drugs progressively advancing from short-acting to long-acting formulations. GLP-1 receptor agonists have achieved progressively elevated positioning in treatment guidelines. Biased GLP-1RA was specially referenced in the newest guideline of Chinese diabetes society in 2024.

About Ecnoglutide

Ecnoglutide injection, originally discovered and developed by Sciwind Biosciences, is the world's first approved cAMP-biased GLP-1 receptor agonist enhancing clinical efficacy and accessibility. Ecnoglutide injection has successfully completed three Phase III clinical trials. From Phase I through Phase III, ecnoglutide injection has consistently demonstrated a favorable safety profile and strong efficacy, with the findings published in leading metabolic journals, underscoring its potential as a promising therapy for patients with metabolic diseases.