The 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD 2026) was held in Milan, Italy, on September 28, 2026. At this year's congress, Gan & Lee Pharmaceuticals showcased new clinical results for insulin ludefen, its investigational once-weekly basal insulin, underscoring the company's continued progress in insulin innovation and its growing visibility within the global diabetes community.

During the meeting, detail results from the pivotal phase 3 SUPER-1 and SUPER-2 studies of insulin ludefen were presented in oral sessions for the first time. The presentations drew strong interest from the international diabetes community and sparked discussion around the therapy's glycaemic efficacy, safety profile, differentiated characteristics and potential role in clinical practice. The findings further highlighted the clinical potential of this new-generation once-weekly basal insulin developed in China.

Previously, both pivotal phase 3 trials of insulin ludefen conducted in China, SUPER-1 and SUPER-2, had met their respective primary endpoints. At Week 26, once-weekly insulin ludefen demonstrated statistically superior reductions in glycated hemoglobin (HbA1c) compared with once-daily insulin glargine U100 and once-daily insulin degludec, respectively. The presentations at EASD 2026 provided further detailed findings from these two pivotal Phase 3 trials, offering more comprehensive evidence for evaluating the efficacy, safety and potential clinical value of insulin ludefen.

Pivotal Phase 3 Data for Insulin Ludefen Presented at EASD 2026, Demonstrating Superior Glycaemic Efficacy Versus Once-Daily Basal Insulin Comparators

SUPER-1: Once-weekly insulin ludefen demonstrated superior glycaemic efficacy versus once-daily insulin glargine U100 in insulin-naïve adults with type 2 diabetes

SUPER-1 is a 52-week phase 3 treat-to-target study conducted across 84 medical centres in China, comprising a 26-week main treatment period followed by a 26-week extension period (ClinicalTrials.gov Identifier: NCT06767735). A total of 588 Chinese adults with type 2 diabetes mellitus (T2DM) who were insulin-naïve were enrolled. The study compared the efficacy and safety of once-weekly insulin ludefen injection with once-daily insulin glargine U100 injection (Lantus®), both in combination with non-insulin glucose-lowering agents.

At Week 26, the primary endpoint analysis showed that the mean reduction in HbA1c from baseline was 1.45% (baseline: 8.47%) in the insulin ludefen group, compared with 1.22% in the insulin glargine U100 group (baseline: 8.50%). The estimated treatment difference was −0.23% (95% CI: −0.34, −0.12; p<0.0001), demonstrating the superiority of insulin ludefen over insulin glargine U100. During Weeks 25–26, continuous glucose monitoring showed improvements in time in range (TIR, 3.9–10.0 mmol/L, inclusive) from baseline in both groups, with a numerically higher TIR in the insulin ludefen group than in the insulin glargine U100 group (76.9% vs. 70.9%). 

In addition, a higher proportion of participants receiving insulin ludefen achieved the composite treatment target. The proportion of participants achieving HbA1c <7.0% without clinically significant (level 2) or severe (level 3) hypoglycaemia during the final 12 weeks of treatment was 49.0% with once-weekly insulin ludefen versus 35.1% with once-daily insulin glargine U100.

In terms of safety, once-weekly insulin ludefen demonstrated a favourable safety and tolerability profile. The incidence of adverse events was similar between the two groups, with most events being mild in severity. No severe hypoglycaemic events were reported in either group.

SUPER-2: Once-weekly insulin ludefen demonstrated superior glycaemic efficacy versus once-daily insulin degludec in adults previously treated with basal insulin

SUPER-2 is a 26-week phase 3 treat-to-target study conducted across 80 medical centres in China (ClinicalTrials.gov Identifier: NCT06767748). A total of 631 Chinese adults with T2DM who had previously received basal insulin therapy were enrolled to compare the efficacy and safety of once-weekly insulin ludefen injection with once-daily insulin degludec (Tresiba®), with or without non-insulin glucose-lowering agents.

At Week 26, the primary endpoint analysis showed that the mean reduction in HbA1c from baseline was 1.00% (baseline: 8.48%) in the insulin ludefen group, compared with 0.58% (baseline: 8.50%) in the insulin degludec group. The estimated treatment difference was −0.42% (95% CI: −0.55, −0.30; p<0.0001), demonstrating the superiority of insulin ludefen over insulin degludec.

Insulin ludefen also showed a higher proportion of participants achieving the composite treatment target. The proportion of participants achieving HbA1c <7.0% without clinically significant (level 2) or severe (level 3) hypoglycaemia during the final 12 weeks of treatment was 23.7% with once-weekly insulin ludefen versus 13.7% with once-daily insulin degludec.

Patient-reported outcomes showed a greater numerical improvement in treatment satisfaction with insulin ludefen. At Week 26, the change from baseline in the overall treatment satisfaction score of the Diabetes Treatment Satisfaction Questionnaire, status version (DTSQs), was 4.2 in the insulin ludefen group versus 3.1 in the insulin degludec group, with an estimated treatment difference of 1.1 (95% CI: 0.5, 1.7; p<0.001).

In terms of safety, once-weekly insulin ludefen demonstrated a favourable safety and tolerability profile. The incidence of adverse events was similar between the two groups, with most events being mild in severity. No unexpected safety findings were observed, and no severe hypoglycaemic events were reported in either group.

Detailed results from the SUPER studies are also planned for publication in academic journals.

Professor Liming Chen, Principal Investigator of SUPER-1

“It was a great pleasure to present the results of the SUPER-1 study of insulin ludefen at this year’s EASD Annual Meeting and to exchange perspectives with diabetes experts from different countries and regions. Experts attending the session engaged in lively discussions around the glycaemic efficacy of once-weekly basal insulin, hypoglycaemia management and its potential future role in clinical practice. I am very proud to see an innovative basal insulin independently developed in China receiving broad attention from the international diabetes community. For people with type 2 diabetes, initiating insulin therapy is an important step toward achieving long-term glycaemic management. In clinical practice, concerns about injection frequency, hypoglycaemia and treatment complexity may pose barriers to initiating insulin therapy. The molecular design of insulin ludefen has the potential to help more patients initiate insulin therapy earlier and remain on treatment over the long term, supporting more sustained and stable glycaemic management. In SUPER-1, once-weekly insulin ludefen not only achieved effective glycaemic control, but also enabled a higher proportion of participants to achieve HbA1c targets without level 2 or level 3 hypoglycaemia compared with once-daily basal insulin. These findings provide new clinical evidence for Chinese patients with type 2 diabetes, and we look forward to insulin ludefen potentially offering a more convenient treatment option to more patients in the future.”

Professor Yiming Mu, Principal Investigator of SUPER-2

“Type 2 diabetes is a chronic disease requiring long-term management. For patients who are already receiving basal insulin therapy, an important challenge in clinical practice is how to further improve glycaemic control while reducing treatment burden, improving treatment satisfaction and supporting patients’ willingness to continue long-term therapy. The SUPER-2 study showed that, among patients with type 2 diabetes previously treated with basal insulin, once-weekly insulin ludefen demonstrated superior glycaemic efficacy compared with once-daily insulin degludec, while showing a favourable safety and tolerability profile. At the same time, patients receiving insulin ludefen experienced a greater improvement in treatment satisfaction. A once-weekly dosing regimen has the potential to further reduce injection burden while maintaining effective glycaemic management, helping patients better persist with long-term insulin therapy. It is very encouraging to see an innovative once-weekly basal insulin independently developed in China achieve this progress. I would also like to express my sincere gratitude to all investigators, healthcare professionals and study participants who contributed to the study. We look forward to accumulating further long-term evidence in the future and ultimately benefiting more people living with diabetes.”

Professor Guang Wang, Principal Investigator of SUPER-2

“For people with type 2 diabetes who are already receiving basal insulin therapy, long-term glycaemic management requires consideration not only of glucose-lowering efficacy and safety, but also of treatment convenience and patients’ acceptance of therapy. The SUPER-2 study showed that, among Chinese adults with type 2 diabetes previously treated with basal insulin, once-weekly insulin ludefen achieved better glycaemic control than once-daily insulin degludec, while demonstrating a favourable safety and tolerability profile and showing positive improvements in treatment satisfaction. These findings highlight the clinical potential of a once-weekly basal insulin regimen from multiple perspectives. As diabetes management continues to evolve toward a more long-term, comprehensive and patient-centred approach, an important question in clinical practice is how to maintain effective glycaemic control while reducing treatment burden, improving patients’ treatment experience and supporting long-term persistence with therapy. The SUPER-2 study of insulin ludefen provides new clinical evidence for the use of once-weekly basal insulin in Chinese people with type 2 diabetes, and we look forward to insulin ludefen becoming a more convenient basal insulin treatment option for patients in the future.”

About Insulin Ludefen Injection

Insulin ludefen (development code: GZR4) injection is an investigational ultra-long-acting once-weekly basal insulin independently developed by Gan & Lee Pharmaceuticals. With only one injection per week, insulin ludefen is designed to provide effective and stable glycaemic control throughout the week. Insulin ludefen is expected to help people with diabetes overcome barriers associated with insulin injections, initiate insulin therapy earlier and remain on treatment over the long term, supporting simpler, effective and safe long-term glycaemic management and ultimately helping patients achieve a better quality of life.

Completed phase 3 studies have shown that once-weekly insulin ludefen achieved superior reductions in HbA1c compared with once-daily insulin glargine U100 and once-daily insulin degludec in people with type 2 diabetes. The global clinical development programme for insulin ludefen has now entered phase 3 development. As an innovative once-weekly basal insulin candidate, insulin ludefen has the potential to further advance insulin treatment and provide a more convenient therapeutic option for people living with diabetes.

About Gan & Lee

Gan & Lee Pharmaceuticals is a high-tech biopharmaceutical company and the first in China to master industrial-scale manufacturing technologies for recombinant insulin analogs. The Company has established a comprehensive insulin research and development pipeline.

Currently, Gan & Lee offers six core insulin products, including five insulin analogs: insulin glargine injection (Basalin^®; EU brand name Ondibta^®), insulin lispro injection (Prandilin^®; EU brand name: Bysumlog^®), insulin aspart injection (Rapilin^®; EU brand name: Dazparda^®), premixed insulin lispro protamine suspension injection (25R) (Prandilin^®25), and insulin aspart 30 injection (Rapilin^®30); as well as one human insulin product, premixed human insulin protamine suspension injection (30R) (Similin^®30), together with related delivery devices. These products cover the long-acting, rapid-acting, and premixed insulins.

In China's second round of national volume-based procurement for insulin, Gan & Lee ranked first among selected companies by contracted volume for insulin analogs, further strengthening its domestic market position. In parallel, the Company continues to advance its international expansion.  Insulin glargine injection, insulin lispro injection, and insulin aspart injection have all received marketing authorization from the European Commission (EC). Gan & Lee is steadily progressing toward its goal of becoming a key global participant in the field of metabolic diseases.

Looking forward, Gan & Lee is committed to achieving comprehensive coverage across the diabetes treatment landscape and further enhancing its competitive position in this therapeutic area. The Company will also actively pursue the development of innovative chemical drugs and biologics, with a strategic focus on metabolic diseases, cardiovascular diseases, and other therapeutic areas.