Insulin glargine (Sanofi)

Gan & Lee Pharmaceuticals (SSE: 603087) reported that its investigational once-weekly basal insulin analog, GZR4, met the primary endpoint of superior HbA1c reduction versus both insulin glargine U100 (Lantus) and insulin degludec (Tresiba) across two pivotal Phase III trials in adults with type 2 diabetes, positioning the molecule as a direct challenger to Novo Nordisk’s recently FDA-approved insulin icodec (Awiqli). The SUPER-1 and SUPER-2 trials are active-controlled, treat-to-target Phase III studies enrolling 588 insulin-naïve and 631 basal-insulin-experienced Chinese adults with type 2 diabetes, respectively, conducted across more than 80 medical centers in China. In SUPER-1, the estimated mean HbA1c change from baseline at 26 weeks was -1.45% with GZR4 versus -1.22% with glargine U100, a between-group difference of -0.23%. In SUPER-2, GZR4 produced a -1.00% reduction compared with -0.58% for degludec, a difference of -0.42%. Both trials also showed GZR4 achieved a higher rate of the composite endpoint of HbA1c below 7.0% or at or below 6.5% without clinically significant or severe hypoglycemia. No severe (Level 3) hypoglycemic events occurred in either treatment group across both trials. GZR4 is an ultra-long-acting basal insulin analog engineered to provide full-week basal insulin coverage from a single subcutaneous injection, without requiring a loading dose. The absence of a loading dose distinguishes it from Awiqli, which requires a double maintenance dose in the first week to reach steady-state rapidly. The SUPER program describes a greater than 85% reduction in annual injection frequency compared with once-daily regimens — from approximately 365 injections per year to 52. The competitive context is acute. Novo Nordisk’s Awiqli received FDA approval for adults with type 2 diabetes on March 26, 2026 — five days before Gan & Lee released the SUPER-1 and SUPER-2 top-line data. Awiqli, which uses albumin binding to extend its half-life to approximately 196 hours, is now the only approved once-weekly basal insulin in the US market. GZR4 enters that comparison as an investigational molecule with Phase III superiority data versus daily analogs, but without head-to-head data against icodec yet available. That comparison is the subject of SUPER-8, a 26-week trial enrolling 300 patients with type 2 diabetes previously treated with basal insulin, with results expected within the next 12 months. Cross-trial comparisons are limited by differences in patient populations, titration algorithms, and background therapies. The magnitude of HbA1c separation in SUPER-2 — 0.42 percentage points versus degludec — is notable within the context of basal insulin trials, where active comparators are themselves well-optimized agents. The SUPER-1 difference of 0.23 percentage points versus glargine U100 is more modest, though both results met pre-specified superiority thresholds. Full statistical outputs, including confidence intervals and p-values, have not yet been disclosed; detailed results are planned for presentation at a scientific conference and peer-reviewed publication. The trials enrolled exclusively Chinese adults, which will be relevant to any regulatory filing strategy outside China. The SUPER program is described as a global Phase III development program, though the four currently initiated trials are all China-based. Whether Gan & Lee pursues regulatory submissions in the US or EU, and whether additional international trials are planned, was not addressed in the top-line release. Gan & Lee also has two additional SUPER trials underway: SUPER-3, enrolling 580 patients on basal-bolus therapy, comparing GZR4 against glargine U100 in combination with insulin aspart; and SUPER-8, the icodec head-to-head. The full dataset from all four trials will determine the breadth of the clinical package available for any regulatory submission. Detailed results from SUPER-1 and SUPER-2 are planned for presentation at a scientific conference later in 2026, with peer-reviewed publication to follow. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

BEIJING and BRIDGEWATER, N.J., March 31, 2026 /PRNewswire/ -- Gan & Lee Pharmaceuticals (SSE: 603087) today announced that two pivotal phase 3 clinical trials, SUPER-1 and SUPER-2, evaluating investigative once-weekly insulin GZR4 Injection, have successfully met their pre-specified primary endpoints. After 26 weeks of treatment, once-weekly GZR4 demonstrated statistically significant superior efficacy in reducing glycated hemoglobin A1c (HbA1c)* compared with once-daily insulin glargine U100 (Lantus®) and once-daily insulin degludec (Tresiba®). SUPER-1: Trial in Insulin-Naïve Patients with Type 2 Diabetes Mellitus SUPER-1 is a 52-week (26-week main phase plus 26-week extension phase), phase 3, treat-to-target trial investigating the efficacy and safety of once-weekly GZR4 versus once-daily insulin glargine U100 (Lantus®), both in combination with non-insulin anti-diabetic treatment, in 588 insulin-naïve Chinese adults with type 2 diabetes mellitus (T2DM) across 84 medical sites in China (ClinicalTrials.gov Identifier: NCT06767735). The trial met its primary endpoint. GZR4 demonstrated statistically significant superiority in HbA1c reduction versus insulin glargine U100: after 26 weeks of treatment, the estimated mean change in HbA1c from baseline was -1.45% in the GZR4 group versus -1.22% in the insulin glargine U100 group, with a statistically significant estimated between-group treatment difference of -0.23%. GZR4 also achieved a significantly higher rate of safe glycemic target attainment: the treatment group outperformed the insulin glargine U100 group on the clinically relevant composite endpoint of achieving HbA1c <7.0% or ≤6.5% without experiencing clinically significant (Level 2) or severe (Level 3) hypoglycemia. Once-weekly GZR4 demonstrated a favorable safety and tolerability profile. No severe (Level 3) hypoglycemic events occurred in either treatment group. SUPER-2: Trial in Patients with Type 2 Diabetes Mellitus Previously Treated with Basal Insulin SUPER-2 is a 26-week, phase 3, treat-to-target trial investigating the efficacy and safety of once-weekly GZR4 versus once-daily insulin degludec (Tresiba®), with or without concomitant non-insulin anti-diabetic treatment, in 631 Chinese adult patients with T2DM previously treated with basal insulin across 82 medical centers in China (ClinicalTrials.gov Identifier: NCT06767748). The trial met its primary endpoint. GZR4 demonstrated statistically significant superiority in HbA1c reduction versus insulin degludec: after 26 weeks of treatment, the estimated mean change in HbA1c from baseline was -1.00% in the GZR4 group versus -0.58% in the insulin degludec group, a statistically significant estimated between-group treatment difference of -0.42%. GZR4 also delivered a significantly higher rate of safe glycemic target attainment, outperforming the insulin degludec group on the composite endpoint of achieving HbA1c <7.0% or ≤6.5% without clinically meaningful (Level 2) or severe (Level 3) hypoglycemia. Once-weekly GZR4 demonstrated a favorable safety and tolerability profile. No severe (Level 3) hypoglycemic events occurred in either treatment group. Detailed results from SUPER-1 and SUPER-2 are planned for presentation at this year's scientific conference and will be submitted for publication in peer-reviewed international academic journals. Additional findings from the GZR4 Injection's ongoing clinical program are expected to be released over the following 12 months. *Glycated hemoglobin A1c (HbA1c): A biomarker that reflects average blood glucose levels over the preceding 2 to 3 months and is the gold-standard endpoint for evaluating the efficacy of anti-diabetic treatment. The above data are derived from the modified Intention-to-treat (mITT) Set and Safety Set (SS) under the treatment policy. Dr. Chen Wei from Gan & Lee Pharmaceuticals remarked: "We are thrilled to report positive top-line results from the SUPER-1 and SUPER-2 trials. This robust dataset confirms that GZR4 delivers statistically significant superiority over the active comparators on the primary endpoint of HbA1c reduction, with an overall safety profile closely aligned with that of marketed once-daily basal insulins. These findings position GZR4 as a promising, enhanced option for patients with T2DM who require basal insulin therapy. As a novel once-weekly insulin, GZR4 Injection has demonstrated compelling best-in-class potential. The SUPER phase 3 pivotal clinical program includes four randomized, active-controlled, treat-to-target trials conducted across China in approximately 2,120 adults with inadequately controlled T2DM, to deliver a systematic evaluation of the efficacy and safety of once-weekly GZR4 versus once-daily basal insulins. Compared with once-daily formulations, once-weekly GZR4 delivers a more than 85% reduction in annual injection frequency, with no need for an additional loading dose. This simplified regimen is engineered to improve treatment adherence, optimize long-term glycemic control, and drive meaningful, sustained improvements in the quality of life for people living with diabetes. At a time when industry players are scaling back investment in insulin research and development, Gan & Lee Pharmaceuticals is accelerating the development of GZR4. This progress fully embodies our unwavering commitment to pioneering innovation in diabetes care, and our steadfast dedication to safeguarding patient health." About the SUPER Clinical Program The SUPER program is a large-scale global phase 3 clinical development program for GZR4 Injection, a proposed once-weekly basal insulin by Gan & Lee. To date, four phase 3 clinical trials have been initiated in China: SUPER-1: A 52-week trial enrolling 588 insulin-naïve adults with T2DM, comparing the efficacy and safety of once-weekly GZR4 Injection versus once-daily insulin glargine U100 (Lantus®), both in combination with non-insulin anti-diabetic treatment. SUPER-2: A 26-week trial enrolling 631 adults with T2DM previously treated with basal insulin, comparing the efficacy and safety of once-weekly GZR4 Injection versus once-daily insulin degludec (Tresiba®), with or without concomitant non-insulin anti-diabetic treatment. SUPER-3: A 26-week trial enrolling 580 patients with T2DM previously treated with basal-bolus insulin therapy, comparing the efficacy and safety of once-weekly GZR4 Injection versus once-daily insulin glargine U100 (Lantus®) in combination with insulin aspart, with or without concomitant non-insulin anti-diabetic treatment. SUPER-8: A 26-week trial enrolling 300 patients with T2DM previously treated with basal insulin, comparing the efficacy and safety of GZR4 Injection versus insulin icodec (Awiqili®), with or without concomitant non-insulin anti-diabetic treatment. About GZR4 Injection GZR4 Injection is an investigational ultra-long-acting once-weekly basal insulin analog independently developed by Gan & Lee Pharmaceuticals to cover the basal insulin requirements for a full week with a single subcutaneous injection. GZR4 Injection is designed to help people with diabetes overcome barriers to injection, initiate and sustain insulin therapy earlier, optimize long-term diabetes management, and improve quality of life. Completed phase 3 clinical trial results show that once-weekly GZR4 Injection is superior to once-daily insulin glargine U100 and insulin degludec in reducing HbA1c levels in adult patients with T2DM. The global clinical development of GZR4 Injection is currently in the phase 3 stage. Forward-looking statements Forward-looking statements are based on our expectations and assumptions as of the date of the statements. Actual results may differ materially from those expressed in these forward-looking statements due to a variety of factors, and we can give no assurance that such results will be achieved in the future. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 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