<div id="readability-page-1"><div> <div> , /PRNewswire/ -- Gan &amp; 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 &lt;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 &lt;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 &amp; Lee Pharmaceuticals remarked: &#34;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 &amp; 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.&#34; 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 &amp; Lee. To date, four phase 3 clinical trials have been initiated in China: <ul type="disc"> <li>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.</li> <li>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.</li> <li>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.</li> <li>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.</li> </ul> About GZR4 Injection GZR4 Injection is an investigational ultra-long-acting once-weekly basal insulin analog independently developed by Gan &amp; 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. SOURCE Gan &amp; Lee Pharmaceuticals <img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMzMxJk5ld3NJdGVtSWQ9Q04yMzMxMCZUcmFuc21pc3Npb25fSWQ9MjAyNjAzMzEwOTM2UFJfTkVXU19VU1BSX19fX19DTjIzMzEw?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" original-src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMzMxJk5ld3NJdGVtSWQ9Q04yMzMxMCZUcmFuc21pc3Npb25fSWQ9MjAyNjAzMzEwOTM2UFJfTkVXU19VU1BSX19fX19DTjIzMzEw"/></div> </div></div>

603087

Gan & Lee Pharmaceuticals announced that its once-weekly GZR4 Injection met primary endpoints in two pivotal phase 3 trials, SUPER-1 and SUPER-2. The trials showed GZR4 significantly reduced HbA1c levels compared to daily insulin treatments, with favorable safety profiles. The SUPER-1 trial involved insulin-naïve patients, while SUPER-2 included those previously treated with basal insulin. Results will be presented at a scientific conference and submitted for publication. GZR4 offers a promising alternative for type 2 diabetes management, reducing injection frequency and improving patient adherence.

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Gan & Lee

09:36 ETGan & Lee Pharmaceuticals' Once-Weekly Basal Insulin GZR4 Injection Meets Primary Endpoints in Two Pivotal Phase 3 Clinical Trials: SUPER-1 and SUPER-2