ObesityWeek®️ 2024 | Gan & Lee Pharmaceuticals Orally Presents Phase 2b Clinical Data for GZR18 Injection in Chinese Overweight and Obese Adults

• Obese or 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, Nov. 11, 2024 /PRNewswire/ -- Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087) announced that the results of the Phase 2b clinical study of GZR18 injection, a bi-weekly (twice a month) glucagon-like peptide-1 (GLP-1) receptor agonist independently developed by the company, in adult overweight/obese patients in China were presented as an oral presentation at ObesityWeek^®️ 2024.

Statement:

1. GZR18 is an investigational drug and is not approved for use in any country.
2. Gan & Lee Pharmaceuticals does not endorse the use of any unapproved drug or indication.

The Phase 2b clinical trial (CTR20231695) was a multicenter, randomized, double-blind, placebo-controlled, dose-finding study designed to evaluate the efficacy and safety of bi-weekly (Q2W) and once-weekly (QW) dosing regimens of GZR18 injection. The study enrolled a total of 340 participants, all of whom were obese (BMI≥28 kg/m²) or overweight (BMI≥24 kg/m²) with at least one weight-related comorbidity and whose weight was poorly controlled by diet and exercise. Participants were randomly assigned to receive 12 mg (n=52), 18 mg (n=53), 24 mg (n=52), 48 mg (n=64) GZR18 injections bi-weekly, or 24 mg (n=53) once-weekly GZR18 injection, or placebo (n=66) for 30 weeks (including a dose escalation period). The primary efficacy endpoint was the percentage change in body weight from baseline after 30 weeks of treatment.

The study results showed a significant reduction in body weight from baseline at week 30 in participants receiving different doses and dosing frequencies of GZR18 injection, with weight loss not yet reaching a plateau. In the Q2W GZR18 dose groups, participants experienced dose-dependent weight loss: 11.15% (1.04) in the 12 mg group, 13.22% (0.95) in the 18 mg group, 14.25% (1.01) in the 24 mg group, and 17.29% (0.99) in the 48 mg group. In the QW 24 mg group, participants experienced a weight reduction of 17.78% (1.01), while the placebo group showed only a -0.99% (0.91) change. Moreover, there was no significant difference in efficacy between the 48 mg Q2W and 24 mg QW groups (one-sided test P>0.025). In the 48 mg Q2W GZR18 group, the proportions of participants achieving ≥5%, 10%, and 20% weight loss were 97.8%, 82.2%, and 37.8%, respectively.

GZR18 injection was safe and well tolerated, with the most common adverse events being mild to moderate gastrointestinal reactions. No serious adverse events were reported in any treatment group.

*Trial data are presented as mean (standard error).

The detailed results of the Phase 2b study of GZR18 Injection will be published in a peer-reviewed journal.

Dr. Zhong-ru Gan, Chairman of Gan & Lee Pharmaceuticals, commented:

"The results of this Phase 2b study further validate the excellent performance of GZR18 injection in weight management, particularly with the bi-weekly dosing regimen, which has shown comparable efficacy to the once-weekly regimen. The bi-weekly formulation of GLP-1 has the potential to enhance patient adherence, thereby improving long-term weight management outcomes. GZR18 injection, as the first single-target GLP-1 biweekly formulation, clinical data has demonstrated weight loss effects comparable to or even better than multi-target GLP-1 once-weekly formulations, providing new insights for the future development of GLP-1 drugs. The development of the bi-weekly GZR18 injection is expected to offer more flexible treatment options for patients with obesity, and we look forward to further validating these findings in the upcoming Phase 3 clinical trials."

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 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 first among all selected 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.

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