• Obese and overweight participants receiving bi-weekly doses of 12 mg, 18 mg, 24 mg, 48 mg, and once-weekly dose of 24 mg GZR18 for 30 weeks achieved mean percent changes in body weight from baseline of -11.15%, -13.22%, -14.25%, -17.29%, and -17.78%, respectively, with the placebo group at -0.99%; and at 30 weeks, participants' body weight continued to decrease.

• The clinical efficacy and safety of bi-weekly 48 mg and once-weekly 24 mg GZR18 injections were comparable, with no significant difference in mean percent change in body weight from baseline between the two groups (one-sided test, P > 0.025).

• GZR18 injections were safe and well tolerated, with the most commonly reported adverse events being gastrointestinal reactions, comparable to similar drugs.

BEIJING, July 22, 2024 /PRNewswire/ — Recently, Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087) announced that its independently developed long-acting GLP-1 receptor agonist (GLP-1 RA), GZR18 injection, has achieved positive results in a clinical trial for adults with obesity/overweight in China.

Statement:

1. GZR18 injection is an investigational drug and has not yet been approved in China.

2. Gan & Lee Pharmaceuticals does not recommend the use of any unapproved drugs/indications.

The phase IIb clinical trial (CTR20231695) is a multi-center, randomized, double-blind, placebo-controlled study conducted at 25 clinical trial centers in China, recruiting a total of 340 participants. The participants were overweight (BMI ≥24 kg/m²) with at least one weight-related comorbidity or obese (BMI ≥28 kg/m²) adults with poorly controlled diet and exercise. They were randomized to receive bi-weekly (Q2W) doses of 12 mg, 18 mg, 24 mg, 48 mg, and once-weekly (QW) dose of 24 mg GZR18 injection or placebo for 30 weeks (including a dose escalation period). The primary efficacy endpoint of the study was the percent change in body weight from baseline after 30 weeks of treatment. The study assessed changes from baseline in average weight, waist circumference, waist-to-hip ratio, body mass index (BMI), glycemic parameters, and the safety and tolerability of the drug.

After 30 weeks of treatment, compared to the placebo group, participants receiving different doses and frequencies of GZR18 injection (12 mg, 18 mg, 24 mg, and 48 mg Q2W; 24 mg QW) had a significant reduction in the percent change in body weight from baseline. The mean percent changes in body weight from baseline was -11.15% (12 mg group, Q2W), -13.22% (18 mg group, Q2W), -14.25% (24 mg group, Q2W), -17.29% (48 mg group, Q2W), and -17.78% (24 mg group, QW), all more effective than the placebo group (reduced by 0.99%). There was no significant difference in mean percent change in body weight between the 48 mg Q2W group and the 24 mg QW group (one-sided test, P > 0.025).

In this study, the bi-weekly GZR18 injections were generally safe and well tolerated , consistent with the known safety signals of GLP-1 receptor agonists. The most common adverse events were gastrointestinal reactions, most of which were mild to moderate in severity, comparable to other GLP-1 RAs.

 The comprehensive results of this phase IIb study are planned to be announced later this year and will be published in a peer-reviewed journal.

About GZR18

GZR18 injection, independently developed by Gan & Lee, is a once-weekly or potential bi-weekly GLP-1 receptor agonist intended for the treatment of T2DM in adults and for weight management in obese/overweight individuals. Preclinical data suggests that GZR18 has potential benefits in reducing blood glucose levels and weight¹. Currently, the global development of GZR18 has entered the Phase II clinical research 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.

Reference:

1. Zhang M, Zhang Y, Peng X, He A, Wang Y, Deng Y, Cui C, Xue F, Wei B, Xing W, Qian Y, Mazuranic M, Chen W. GZR18, a novel long-acting GLP-1 analog, demonstrated positive in vitro and in vivo pharmacokinetic and pharmacodynamic characteristics in animal models. Eur J Pharmacol. 2022 Aug 5;928:175107. doi: 10.1016/j.ejphar.2022.175107. Epub 2022 Jun 16. PMID: 35718129.

About Gan & Lee

Gan & Lee Pharmaceuticals developed the first Chinese domestic insulin analog. Currently, Gan & Lee has six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin^®), fast-acting lispro injection (Prandilin^™), fast-acting aspart injection (Rapilin^®), mixed protamine zinc lispro injection (25R) (Prandilin^™25), aspart 30 injection (Rapilin^®30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin^®30). The company has two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine^®).

In China's 2024 National Insulin-Specific Centralized Procurement, Gan & Lee Pharmaceuticals ranked second overall and first among domestic companies in terms of procurement demand for insulin analogs. The company is also making strides in international markets, with the disposable pen needle (GanleeFine^®) approved by the US Food and Drug Administration (FDA) in 2020 and received GMP inspection approval from the European Medicines Agency (EMA) in 2024. These achievements significantly boost Gan & Lee’s competitiveness in both international and domestic markets.

In the future, Gan & Lee will strive for comprehensive coverage in diabetes treatment. Moving forward with 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.