Gan & Lee’s Once-Weekly Basal insulin GZR4 Injection Met the Primary Endpoint in the Pivotal Phase 3 SUPER-3 Trial and Demonstrated Superior HbA1c Reduction Versus Insulin Glargine U100

Beijing, China, June 1, 2026- Gan & Lee Pharmaceuticals (hereinafter"Gan & Lee" , stock code: 603087.SH ) announced that SUPER-3, a pivotal Phase 3 clinical trial conducted in China evaluating investigative once-weekly basal insulin GZR4 Injection, have successfully met its pre-specified primary endpoint. The study results showed that after 26 weeks of treatment in combination with insulin aspart, once-weekly GZR4 injection demonstrated statistically significantly superiority in HbA1c reduction compared with once-daily insulin glargine U100. Previously, GZR4 demonstrated superior efficacy compared with insulin glargine U100 in insulin-naïve patients inadequately controlled with oral antidiabetic drugs and compared with insulin degludec in patients previously treated with basal insulin therapy. The positive results from SUPER-3 further confirm the superior efficacy of GZR4 Injection compared with once-daily basal insulin. SUPER-3: GZR4 Injection combined with insulin aspart demonstrated superior HbA1c reduction in adults previously treated with basal-bolus insulin or premixed/dual insulin analogs. SUPER-3 is a 26-week, treat-to-target Phase 3 clinical study conducted at 80 medical sites across China (ClinicalTrials.gov Identifier: NCT06767761). The study enrolled 596 adults with type 2 diabetes (T2DM) who had previously been treated with basal-bolus insulin, premixed insulin analogs or dual insulin analog. It evaluated once-weekly GZR4 injection compared with once-daily insulin glargine U100 (Lantus ® ) injection, both in combination with insulin aspart, with or without non-insulin antidiabetic agents. The study met its primary endpoint. In patients with T2DM previously treated with bolus insulin, premixed insulin analogs, or dual insulin analogs, once-weekly GZR4 Injection, used as the basal insulin component in combination with prandial insulin aspart, demonstrated superior HbA1c reduction versus once-daily insulin glargine U100. After 26 weeks of treatment, compared with the once-daily glargine insulin U100 regimen, the once-weekly GZR4 injection demonstrated superiority in reducing HbA1c levels (change from baseline: −1.58% vs. −1.41%); the estimated between-group treatment difference was −0.17%, and this difference was statistically significant (p=0.0021, <0.025). Additionally, GZR4 demonstrated a higher rate of safe glycemic target attainment: the once-weekly GZR4 group outperformed the once-daily insulin glargine U100 group on the clinically relevant composite endpoint of achieving HbA1c < 7.0% or ≤ 6.5% without clinically significant (level 2) or severe (level 3) hypoglycemia during the last 12 weeks. Once-weekly GZR4 demonstrated a favorable safety and tolerability profile, with no severe (level 3) hypoglycemic events occurred, while three severe (level 3) hypoglycemic events were reported in the insulin glargine U100 group. The SUPER-3 study focused on a more complex patient population. Compared with insulin- naïve patients or those treated with basal insulin alone, patients treated with basal-bolus insulin, premixed insulin analogs, or dual insulin analogs typically had a longer disease duration, more complex treatment regimens, and a heavier daily injection burden. The positive results of the SUPER-3 study further expand the clinical evidence for GZR4 in patients at different stages of type 2 diabetes treatment, providing key support for the use of once-weekly basal insulin in intensive treatment settings. Detailed results from the SUPER-3 study are scheduled to be presented at upcoming scientific conferences and published in international academic journals. *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 primary efficacy endpoints were derived from the modified intention-to-treat (mITT) population under the treatment strategy, secondary efficacy endpoints from the mITT population under the hypothetical strategy, and safety endpoints from the safety set (SS) population. Professor Zhiguang Zhou, Principal Investigator of the SUPER-3 Study from the Xiangya Hospital of Central South University ,commented:"Basal insulin combined with prandial insulin is a key regimen in the intensive treatment of type 2 diabetes, but multiple daily injections and complex dose management often impose a significant treatment burden on patients. The results of the SUPER-3 study show that once-weekly GZR4 injection combined with prandial insulin achieved the primary endpoint in this intensive treatment population and demonstrated superior HbA1c reduction compared with the insulin glargine U100 combination regimen. These findings provides new clinical evidence for optimizing basal-bolus insulin treatment regimens. For patients with type 2 diabetes requiring long-term insulin therapy, reducing the frequency of basal insulin injections and simplifying treatment complexity may help improve the treatment experience and support long-term adherence." Dr. Wei Chen Chairman and CEO of Gan & Lee, stated:"The achievement of the primary endpoint in the SUPER-3 study marks another significant milestone in the clinical development of GZR4 injection. Following the positive results from the SUPER-1 and SUPER-2 studies, SUPER-3 further validated the therapeutic potential of GZR4 in a more complex patient population, which more closely reflects real-world clinical challenges. With its once-weekly dosing regimen and no requirement for an initial loading dose, GZR4 Injection has the potential to reduce the frequency of basal insulin injections while maintaining effective glycemic control, thereby simplifying the treatment process and helping patients better adhere to long-term insulin therapy. Gan & Lee will continue to advance the clinical development and regulatory efforts for GZR4 Injection, committed to providing higher-quality, more convenient treatment options for diabetes patients in China and worldwide. 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. Key results after 26 weeks of treatment showed that once-weekly GZR4 was superior to once-daily glargine insulin U100 in reducing HbA1c. 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.Key results showed that once-weekly GZR4 was superior to once-daily degludec in reducing HbA1c. SUPER-3: A 26-week trial enrolling 596 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. Key results showed that once-weekly GZR4 achieved superior efficacy in lowering HbA1c compared to once-daily insulin glargine U100. 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 (Awiqli®), 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. Currently, the global development of GZR4 injection has entered Phase 3 clinical trials, and it is expected to lead in the era of fourth-generation insulin in global insulin therapy. 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. 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.

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