From June 5 to 8, local time in the United States, Gan & Lee Pharmaceuticals (hereinafter referred to as Gan & Lee Pharmaceuticals, stock code: 603087.SH) presented four research results from its innovative metabolic pipeline at the 86th Scientific Sessions of the American Diabetes Association (ADA) in New Orleans, USA. These included Bofanglutide (GZR18) Injection, a GLP-1 RA dosed every two weeks; Insulin Ludefen (GZR4) Injection, a once-weekly basal insulin; and GZR102 Injection, a once-weekly fixed-ratio combination of basal insulin and GLP-1 RA. The accepted research abstracts have been published in Diabetes^®, the official journal platform of the ADA.

Gan & Lee Pharmaceuticals' GLP-1 RA Biweekly Formulation: Bofanglutide (GZR18) Injection

Abstract Title: Effect of Renal Impairment on the Pharmacokinetics and Safety of Bofanglutide (1720-P)
Study Overview: This study evaluated pharmacokinetic (PK) differences of Bofanglutide among participants with varying degrees of renal impairment compared with participants with normal renal function, providing evidence to support clinical dosing in patients with renal impairment. Results showed that after a single subcutaneous injection of Bofanglutide, overall  exposure in participants with mild, moderate, and severe renal impairment was generally comparable to that in participants with normal renal function, suggesting that no dose adjustment is required in patients with renal impairment. In terms of safety, the incidence and severity of treatment-emergent adverse events (TEAE) were similar between the renal impairment groups and the normal renal function group. No drug-related serious adverse events were reported.

Abstract Title: Effect of Bofanglutide on the Pharmacokinetics of Metformin (1699-P)
Study Overview: This study aimed to evaluate the effect of Bofanglutide on the PK characteristics of metformin to provide a basis for clinical combination therapy. Results showed that in healthy participants, the effect of Bofanglutide on the PK characteristics of metformin was not clinically significant, and the combination of the two drugs was well tolerated. These findings suggest that no dose adjustment of metformin is required when used in combination with Bofanglutide.

Gan & Lee Pharmaceuticals' Once-Weekly Insulin: Insulin Ludefen (GZR4) Injection

Abstract Title: Effect of Mild or Moderate Renal Impairment on the Pharmacokinetics and Safety of Once-Weekly Insulin GZR4 (1745-P)
Study Overview: This study evaluated the PK, safety, and tolerability of the once-weekly basal insulin GZR4 in participants with mild or moderate renal impairment, providing evidence to support clinical dosing in this patient population. Results indicated that moderate renal impairment had no significant effect on the overall exposure or safety of GZR4, suggesting that no dose adjustment of GZR4 is necessary for patients with mild or moderate renal impairment. GZR4 demonstrated an overall favorable safety and tolerability profile.

Gan & Lee Pharmaceuticals' Once-Weekly Basal Insulin/GLP-1 RA Fixed-Ratio Combination: GZR102 Injection

Abstract Title: Pharmacokinetic and Pharmacodynamic Characterization of GZR102 Injection, a Novel Once-Weekly Fixed-Ratio Combination of Insulin and GLP-1 analog (1822-P)
Study Overview: GZR102 Injection is a novel once-weekly fixed-ratio combination of the long-acting basal insulin GZR4 and the GLP-1 RA Bofanglutide, both of which are currently in phase 3 clinical development. This study evaluated potential drug-drug interactions, as well as PK, and pharmacodynamic (PD) characteristics of GZR102 at in vitro and animal levels. Results showed that no significant interaction between GZR4 and Bofanglutide was observed in vitro or in vivo, and their PK profiles remaining independent. Additionally, GZR102 demonstrated favorable glucose-lowering effects and weight-loss potential, supporting its further clinical development.

Among the above research results, GZR4 and Bofanglutide (GZR18), as flagship assets within Gan & Lee Pharmaceuticals' innovative metabolic pipeline, have both advanced to phase 3 clinical development. With the steady progress of these phase 3 clinical studies, the company anticipates disclosing additional key study data at relevant international academic conferences within 2026, further validating their clinical value and differentiated potential.

About Bofanglutide (GZR18) Injection

Bofanglutide injection (research code: GZR18) is a once every two weeks GLP-1 receptor agonist independently developed by Gan & Lee Pharmaceuticals, intended for the treatment of metabolic diseases, including obesity or overweight and related comorbidities and type 2 diabetes. Bofanglutide injection has demonstrated outstanding weight-loss and glucose-lowering effects in clinical studies, while also providing comprehensive metabolic benefits. The overall safety and tolerability profile of bofanglutide is consistent with other GLP-1 RAs, and it has the potential to become the world's first approved biweekly GLP-1 RA. Currently, seven phase 3 clinical studies of bofanglutide injection are ongoing across indications including obesity or overweight, type 2 diabetes and obesity with obstructive sleep apnea (OSA).

About Insulin Ludefen (GZR4) Injection

GZR4 Injection is an investigational ultra-long-acting once-weekly basal insulin analog independently developed by Gan & Lee Pharmaceuticals to cover the basal insulin requirements for a full week with a single subcutaneous injection. GZR4 Injection is designed to help people with diabetes overcome barriers to injection, initiate and sustain insulin therapy earlier, optimize long-term diabetes management, and improve quality of life. Completed phase 3 clinical trial results show that once-weekly GZR4 Injection is superior to once-daily insulin glargine U100 and insulin degludec in reducing HbA1c levels in adult patients with T2DM. Currently, the global development of GZR4 injection has entered phase 3 clinical trials, and it is expected to lead in the era of fourth-generation insulin in global insulin therapy.

About GZR102 Injection

GZR102 Injection, independently developed by Gan & Lee Pharmaceuticals, is a once-weekly fixed-ratio combination of basal insulin and a GLP-1 RA, composed of the once-weekly insulin GZR4 and the GLP-1 RA Bofanglutide in a fixed ratio. As a once-weekly subcutaneous injection, GZR102 Injection maximizes the synergistic effects of the two drug components through an innovative formulation. The combination of GLP-1 RA and insulin therapy addresses multiple pathophysiological defects of type 2 diabetes, enhancing glucose-lowering efficacy while reducing daily insulin dose, hypoglycemia, weight gain, and other adverse effects. It offers a promising effective, safe, and convenient combination therapy option for patients with type 2 diabetes. Currently, the global development of GZR102 Injection has entered Phase II clinical stage.

About Gan & Lee

Gan & Lee Pharmaceuticals is a high-tech biopharmaceutical company and the first in China to master industrial-scale manufacturing technologies for recombinant insulin analogs. The Company has established a comprehensive insulin research and development pipeline.

Currently, Gan & Lee offers six core insulin products, including five insulin analogs: insulin glargine injection (Basalin^®; EU brand name Ondibta^®), insulin lispro injection (Prandilin^®; EU brand name: Bysumlog^®), insulin aspart injection (Rapilin^®; EU brand name: Dazparda^®), premixed insulin lispro protamine suspension injection (25R) (Prandilin^®25), and insulin aspart 30 injection (Rapilin^®30); as well as one human insulin product, premixed human insulin protamine suspension injection (30R) (Similin^®30), together with related delivery devices. These products cover the long-acting, rapid-acting, and premixed insulins.

In China's second round of national volume-based procurement for insulin, Gan & Lee ranked first among selected companies by contracted volume for insulin analogs, further strengthening its domestic market position. In parallel, the Company continues to advance its international expansion.  Insulin glargine injection, insulin lispro injection, and insulin aspart injection have all received marketing authorization from the European Commission (EC). Gan & Lee is steadily progressing toward its goal of becoming a key global participant in the field of metabolic diseases.

Looking forward, Gan & Lee is committed to achieving comprehensive coverage across the diabetes treatment landscape and further enhancing its competitive position in this therapeutic area. The Company will also actively pursue the development of innovative chemical drugs and biologics, with a strategic focus on metabolic diseases, cardiovascular diseases, and other therapeutic areas.