Gan & Lee Pharmaceuticals Announces Significant Advances in Its New Treatments for Diabetes and Obesity at the 84th Scientific Session of the American Diabetes Association

BEIJING and BRIDGEWATER, NJ, June 22, 2024 /PRNewswire/ — Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087) announced the results of the phase 1b/2a clinical study of the glucagon-like peptide-1 (GLP-1) receptor agonist independently developed by the Company, GZR18 Injection, in an obese/overweight population in Chinaas well as results from two other innovative preclinical insulin studies in poster presentations at the 84th American Diabetes Association (ADA) Scientific Sessions.

This randomized, double-blind, placebo-controlled, dose-escalating phase 1b/2a evaluated the safety, tolerability, pharmacokinetics and efficacy of GZR18 injection in Chinese subjects with obesity/overweight after multiple administrations at a once-weekly (QW) dosing interval or biweekly (Q2W). A total of 36 obese participants were enrolled in the study and randomized in a 3:1 ratio to receive a titrated dose of 1.5 mg to 30 mg of injectable GZR18 or matching placebo for a total of 35 weeks.

Study results demonstrated superior efficacy of injectable GZR18 compared to placebo for weight reduction in Chinese obese subjects. After 35 weeks of treatment, the mean weight change from baseline in the GZR18 QW group was -16.5 kg (95% CI: -19.9 kg, -13.1 kg); the placebo-adjusted mean weight percent change from baseline was -18.6% (95% CI: -25.5%, -11.6%). Although not a comparative study, when compared to published weight reduction data of similar products currently available on the market, the weight reduction ability of GZR18 outperformed semaglutide and targeted tirzepatide on dual incretin receptors in a similar study duration. Meanwhile, the mean weight change from baseline in the GZR18 Q2W group was -11.3 kg (95% CI: -15.4 kg, -7.2 kg); the placebo-adjusted mean weight percent change from baseline was -13.5% (95% CI: -21.0%, -6.0%).

Additionally, the percentage of participants achieving weight reductions ≥5%, 10%, and 15% from baseline were 100.0%, 90.0%, and 80.0% in the GZR18 QW group, respectively, and the percentage of participants achieving weight reductions of ≥5%, 10%, and 15% from baseline were 71.4%, 71.4%, and 42.9%, respectively, in the GZR18 Q2W group. No participant in the placebo group achieved a weight loss of 5% or more.

In terms of safety, GZR18 Injection was well tolerated in obese participants. The most commonly reported adverse events (AEs) during treatment were gastrointestinal AEs, and all were mild to moderate in severity. This is consistent with incretin-based therapies approved for the treatment of obesity and overweight and occurred primarily at the beginning of the dose escalation period. There were no serious hypoglycemic events in this study and no serious adverse events related to the investigational drug.

Gan & Lee also announced that a 30-week, multicenter, placebo-controlled, randomized, double-blind, Phase 2 clinical study evaluating the efficacy and safety of GZR18 injection in adults Chinese people suffering from obesity and overweight, is ongoing. A total of 338 adults with obesity or overweight were enrolled in this study, and the study is exploring a wider dose range and frequency of administration. The main body of Phase 2 is now complete and preliminary study data further confirms the reported phase results. 1b/2a study on obesity/overweight, in particular the positive results obtained with a twice-weekly administration frequency.

“We are very excited about the clinical results of the GZR18 program to date.” Dr. Gan Zhong-ru, founder of Gan & Lee, commented. “Our unique molecular design delays the onset of drug action and attenuates the peak effect, thereby improving drug tolerability and enabling gentle, sustained weight loss in stages. Additionally, GZR18 has a longer duration of action, which should be administered once. every two weeks. Meanwhile, we hope that the clinical results of GZR18 will provide more evidence revealing the mechanism of action of different targets of incretins and glucagon.

Additionally, Gan & Lee announced preclinical testing results of the Company’s investigational products: GZR4, a once-weekly insulin analog, and GZR101, a premixed dual insulin analog, at the 84th Scientific Sessions of the ADA:

Once-weekly insulin analog GZR4

GZR4 is a novel ultra-long-acting basal insulin analog designed for once-weekly administration. Results from preclinical studies showed that GZR4 has a significantly higher affinity for human serum albumin (HSA) and a significantly lower affinity for the insulin receptor than Icodec insulin, another HSA analogue. insulin once a week. Furthermore, unlike Icodec insulin, GZR4 maintains its insulin receptor activating activity after binding to albumin. In studies using animal models of diabetes, the hypoglycemic effect of GZR4 was found to be 2-3 times greater than that of Icodec insulin. Based on preclinical results, GZR4 is expected to be the fourth generation basal insulin that can be administered once a week to achieve effective glycemic control.

Premixed insulin analog GZR101

GZR101 Injection is a premixed insulin analog consisting of a combination of ultra-long-acting basal insulin GZR33 injection and rapid-acting insulin aspart (Rapilin^®). Unlike traditional premixed insulin analogs, the duration of the hypoglycemic effect of the basal insulin component (GZR33) of GZR101 can last 72 hours, and there is no significant peak within 24 hours after reaching a steady state with several injections. When combined with insulin aspart (Rapilin^®️) to make a premixed insulin analog, it provides smooth control of fasting and postprandial blood sugar levels throughout the day. In diabetic animal models, GZR101 is significantly superior to insulin degludec/insulin aspart (IDegAsp) in terms of blood glucose reduction and safety. As a premixed insulin analog developed based on an advanced concept, GZR101 is expected to make an important contribution to blood glucose control and reducing the risk of hypoglycemia in diabetic patients globally.

Conclusions and future directions
The 84th ADA Scientific Sessions highlighted Gan & Lee Pharmaceuticals’ leadership in developing next-generation treatments for diabetes and obesity. With these latest preclinical and clinical results, the Company will continue to advance the development of innovative treatments for diabetes. Ongoing studies and future trials will further confirm the positive influence of these innovative drugs on public health issues related to diabetes and obesity.

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 various factors, and we cannot guarantee 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.

The references：

American Diabetes Association. https://diabetes.org/
ADA 84^th Scientific sessions. https://professional.diabetes.org/scientific-sessions

About Gan & Lee
Gan & Lee Pharmaceuticals developed China’s first domestic insulin analogue. Currently, Gan & Lee offers six core insulin products, including five varieties of insulin analogs: long-acting glargine injection (Basalin^®), fast-acting lispro injection (Prandilin^™), fast-acting aspart injection (Rapilin^®), protamine zinc lispro mixture injection (25R) (Prandilin^™25), aspart 30 injection (Rapilin^®30), and human insulin injection – mixed protamine human insulin injection (30R) (Similin^®30). The company has two medical devices approved in Chinanamely a reusable insulin injection pen (GanleePen) and a disposable pen needle (GanleeFine^®).

In China In 2024, during the domestic centralized purchasing specific to insulin, Gan & Lee Pharmaceuticals ranked second overall and first among domestic companies in terms of purchasing demand for insulin analogs. The company is also making progress in international markets, with the disposable pen needle (GanleeFine^®) approved by the United States Food and Drug Administration (FDA) in 2020 and received GMP inspection approval from the European Medicines Agency (EMA) in 2024. These achievements greatly enhance Gan & Lee’s competitiveness in international and national markets.

In the future, Gan & Lee will strive to provide comprehensive diabetes treatment coverage. Continuing its mission to become a world-class pharmaceutical company, Gan & Lee will also actively develop new chemical entities and biological drugs, focusing on treatments for metabolic diseases, cardiovascular diseases and other therapeutic areas.

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