• Phase 1b/2a Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Bofanglutide (GZR18) Injection in Adult Chinese Patients with Type 2 Diabetes Mellitus (T2DM)

• A Phase 2 Clinical Study to Evaluate the Efficacy and Safety of Bofanglutide Injection and Semaglutide (Ozempic®) Injection in Adult Chinese Patients with T2DM

• Phase 2 Clinical Study Comparing the Efficacy and Safety of Once-Weekly GZR4 Injection Versus Once-Daily Insulin Degludec Injection in Chinese Adult T2DM Patients Poorly Controlled on Oral Glucose-Lowering Agents or Poorly Controlled on Oral Glucose-Lowering Agents Combined with Basal Insulin

BEIJING, China / BRIDGEWATER, N.J., April 10, 2025 - Gan & Lee Pharmaceuticals (Gan & Lee, stock Code: 603087.SH) announced that the phase 2 results of its bi-weekly GLP-1 receptor agonist (GLP-1 RA) Bofanglutide (GZR18) injection, and the once-weekly basal insulin GZR4 injection, will be presented at the 85th American Diabetes Association (ADA) Scientific Sessions. The findings will be featured in oral poster sessions at the conference. The scientific meeting will be held on June 20-23, 2025, in Chicago, USA.

As a leading academic conference, the ADA Scientific Sessions will bring together scientists, researchers, and healthcare professionals worldwide to explore the latest advancements in diabetes prevention and therapy. All selected abstracts from Gan & Lee will be published on the Diabetes® journal online and presented on June 22, 2025, from 12:30 PM to 1:30 PM Central Daylight Time in the Poster Hall.

Abstracts Information

Bi-weekly GLP-1 RA: Bofanglutide (GZR18)

Title: Bofanglutide (GZR18), a Novel GLP-1 RA, Improved Glycemic Control and Cardiometabolic Risk Factors in Chinese Patients with T2D

Category: 12-B Clinical Therapeutics-Incretin-Based Therapies

Abstract Number: 2025-A-4123-Diabetes

Presentation Time: June 22, 2025 | 12:30 PM-1:30 PM CT

Clinical Trial Registration Number: CTR20221509

Title: Efficacy and Safety of Bofanglutide (GZR18), a Bi-weekly GLP-1 RA, Compared to Semaglutide in Chinese Patients with T2D

Category: 12-B Clinical Therapeutics-Incretin-Based Therapies

Abstract Number: 2025-A-4127-Diabetes

Presentation Time: June 22, 2025 | 12:30 PM-1:30 PM CT

Clinical Trial Registration Number: CTR20232069

Weekly insulin analog: GZR4 Injection

Title: Comparable Glycemic Control of Once-Weekly Insulin GZR4 Relative to Once-Daily Insulin Degludec in Insulin-naïve Chinese Subjects with T2D

Category: 12-C Clinical Therapeutics-Insulins

Abstract Number: 2025-A-4109-Diabetes

Presentation Time: June 22, 2025 | 12:30 PM-1:30 PM CT

Clinical Trial Registration Number: CTR20232431 (Part A)

Title: Superior Glycemic Control Achieved with Once-Weekly Insulin GZR4 Compared to Once-Daily Insulin Degludec in Insulin-Treated Chinese Subjects with T2D

Category: 12-C Clinical Therapeutics-Insulins

Abstract Number: 2025-A-4130-Diabetes Presentation

Presentation Time: June 22, 2025 | 12:30 PM-1:30 PM CT

Clinical Trial Registration Number: CTR20232431 (Part B)

About Bofanglutide (GZR18)

Bofanglutide (R&D Code: GZR18) injection, developed by Gan & Lee Pharmaceuticals, is a bi-weekly GLP-1 receptor agonist (RA) indicated for glycemic control in adults with type 2 diabetes and body weight management in overweight/obese individuals. As the potential first bi-weekly GLP-1 RA in the world, early clinical trials have demonstrated its efficacy in weight reduction comparable to or superior to marketed counterparts, with a safety and tolerability profile consistent with the established class of GLP-1 RAs, and significant reductions in both blood glucose levels and body weight.

About GZR4

Gan & Lee Pharmaceuticals' independently developed GZR4  injection is an ultra-long-acting weekly insulin preparation that is expected to provide more stable glucose-lowering effects and reduced intra- or inter-day blood glucose variability. GZR4 is anticipated to help patients with diabetes overcome injection barriers, enable earlier initiation of insulin therapy, optimize long-term diabetes management, and enhance patients' quality of life via once-weekly subcutaneous injection. Early clinical findings indicate that GZR4 demonstrates comparable reduction in HbA1c to insulin degludec in patients with inadequate glycemic control through oral antidiabetic medications. Currently, the global development of GZR4 has entered the Phase 3 clinical trial 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.

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.