--- title: "From basic to enhanced, Gan & Lee's GZR4 third item III phase study has met the standards" type: "News" locale: "en" url: "https://longbridge.com/en/news/289127283.md" description: "Gan & Lee announced that the GZR4 injection phase III clinical study SUPER-3 has reached its primary endpoint. In patients with type 2 diabetes who previously received basal + mealtime insulin treatment, the weekly GZR4 combined with mealtime aspart insulin treatment for 26 weeks significantly reduced glycated hemoglobin compared to the daily G100 insulin regimen. This is the third phase III study of GZR4 that has met its endpoint, confirming its efficacy in enhanced therapy with reduced injections without compromising effectiveness" datetime: "2026-06-09T02:50:41.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/289127283.md) - [en](https://longbridge.com/en/news/289127283.md) - [zh-HK](https://longbridge.com/zh-HK/news/289127283.md) generator: "portal-rs" --- # From basic to enhanced, Gan & Lee's GZR4 third item III phase study has met the standards Recently, Gan & Lee Pharmaceutical Co., Ltd. (hereinafter referred to as "Gan & Lee Pharmaceutical", stock code: 603087.SH) announced that the key Phase III clinical study SUPER-3 of GZR4 injection conducted in China has reached its primary endpoint. The study showed that in patients with type 2 diabetes who had previously received "basal + prandial insulin" or "premixed/dual insulin analog" treatment, those receiving GZR4 combined with prandial aspart insulin once a week for 26 weeks had a significantly better effect on reducing glycated hemoglobin compared to those receiving daily glargine U100 combined with prandial insulin. This is the third Phase III study to achieve superiority for GZR4, following SUPER-1 (comparing glargine U100 in patients with poorly controlled type 2 diabetes who had never used insulin) and SUPER-2 (comparing degludec insulin in patients with poorly controlled type 2 diabetes who had previously received basal insulin), further confirming that GZR4 is more effective than daily basal insulin. Reducing injections without sacrificing efficacy: Weekly injection provides better glycemic control in intensified treatment The SUPER-3 study included 596 patients, who are among the population with a heavy burden in diabetes treatment. They were all type 2 diabetes (T2DM) patients who had already received "basal + prandial insulin treatment" or "premixed insulin analogs or dual insulin analogs treatment," and the need for multiple daily injections and complex dose management brought them a heavy treatment burden. Some patients had a longer disease duration and more complex treatment regimens, making blood sugar control more challenging. In this context, changing the basal insulin from daily to weekly reduced the injection frequency by 85%. For patients, this not only means fewer injection pains and needle consumption but also a substantial improvement in quality of life and a treatment regimen that is easier to adhere to in the long term. Moreover, the reduction in injection frequency did not come at the expense of efficacy. Clinical data from SUPER-3 showed that after 26 weeks of treatment, compared to the daily glargine U100 regimen, the weekly GZR4 injection achieved superiority in reducing HbA1c levels (change from baseline: -1.58% vs. -1.41%); the estimated treatment difference between groups was -0.17%, which is statistically significant. In terms of safety, there were no serious hypoglycemic events in the GZR4 group, while the glargine U100 group reported 3 cases. In the composite endpoint of achieving glycemic targets without clinically significant hypoglycemia, the GZR4 group also outperformed the control group. This means that the weekly injection not only did not increase the risk of hypoglycemia but also achieved better blood sugar control under a more convenient regimen. From "similar" to "superior": The evidence-based value of GZR4 The three SUPER series studies of GZR4 reflect a systematic coverage of patients at different treatment stages. SUPER-1 targeted patients who had never used insulin, verifying the advantages of weekly formulations in initial treatment; SUPER-2 targeted patients who had previously received basal insulin treatment, providing a more convenient treatment regimen and higher treatment adherence while achieving superiority All three studies reached their primary endpoints, and the efficacy was repeatedly validated across different control drugs (insulin glargine U100, degludec insulin) and various patient backgrounds. This robust clinical data provides a solid evidence-based foundation for GZR4's subsequent registration application and market access. From an industry perspective, the development progress of GZR4 reflects the role transformation of Chinese pharmaceutical companies in the global insulin technology iteration. Insulin weekly formulations are not a new concept, but the uniqueness of GZR4 lies in the fact that it does not require an initial loading dose, making it simpler during treatment conversion. This is expected to address the pain points of existing weekly formulation products, which require complex dosage adjustment plans tailored to different patients during the initial treatment conversion, leading to high clinical management difficulty and risk, significantly promoting the use and development of future weekly formulation products. Additionally, its molecular design has shown superior glycemic efficacy in clinical studies compared to daily formulations, rather than merely non-inferior. This "superior among peers" data pattern is not commonly seen in the globalization process of domestically developed insulin in China. For the vast global population of diabetes patients, weekly basal insulin represents a fundamental change in treatment models. Gan & Lee has accumulated comprehensive evidence from the aforementioned three Phase III studies, covering scenarios from newly treated patients to intensified treatment populations. As of now, the global development of GZR4 injection has entered the Phase III clinical stage and is expected to become the first domestically produced weekly insulin formulation. When a weekly injection insulin formulation that requires no loading dose and has superior glycemic efficacy compared to daily formulations stands at the threshold of market launch, it carries not only Gan & Lee's commercial expectations but also serves as a technological declaration of the Chinese biopharmaceutical industry transitioning from "following" to "running alongside." For diabetes patients who face injection needles daily, switching from daily formulations to weekly formulations means a reduction of over 300 injections a year. 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