Beijing, China, May 29, 2026—Gan & Lee Pharmaceuticals (hereinafter"Gan & Lee", stock code: 603087.SH) announced that Bofanglutide Injection , the company's independently developed biweekly glucagon-like peptide-1 receptor agonist (GLP-1 RA), achieved positive topline results in GRADUAL-1, a pivotal Phase 3 clinical study conducted in China to evaluate its efficacy and safety in adults with obesity or overweight. Meanwhile, a Phase 2 clinical study evaluating the efficacy and safety of bofanglutide Injection in adults with overweight/obesity in the United States also met its primary endpoint.

Key Phase 3  Study in China Meets Primary Endpoint: 18.54% Weight Loss at 52 Weeks

The GRADUAL-1 study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study conducted in adults with overweight or obesity in China (ClinicalTrials.gov Identifier: NCT06728124). The study enrolled 640 participants who were randomized to receive bofanglutide injection 24 mg , bofanglutide injection 48 mg , or placebo once every two weeks (Q2W) for 52 weeks. Participants had a mean baseline body weight of 93.71 kg and a mean body mass index (BMI) of 33.28 kg/m^², with baseline characteristics generally well-balanced across treatment groups.

The results showed that after 52 weeks of treatment, participants receiving bofanglutide injection 24 mg and 48 mg achieved mean body weight reductions of 15.12% and 18.54%, respectively, compared with 1.11% in the placebo group. In addition, 91.8% and 98.1% of participants in the bofanglutide injection 24 mg and 48 mg groups , respectively, achieve at least 5% weight loss from baseline.

In addition, Bofanglutide injection also showed improvements comprehensively in cardiovascular and metabolic parameters, including waist circumference, blood pressure, triglycerides, and serum uric acid.

Regarding safety, Bofanglutide injection were generally well tolerated in both the 24 mg and 48 mg groups. The safety profile was consistent with other GLP-1 RA. The most common adverse events were gastrointestinal reactions and were mostly mild to moderate and transient, with no new safety signals identified.

The above topline results were based on analyses of the modified intention-to-treat (mITT) population and the safety set (SS).

U.S. Phase 2 Clinical Study Meets Primary Endpoint: Significant Improvements Across Key Measures

This Phase 2 clinical study (NCT06737042) was a multicenter, randomized, controlled study that enrolled a total of 326 participants across 20 clinical trial sites in the United States. Bofanglutide injection and placebo administered under double-blind conditions, while tirzepatide injection as an open-label comparator. The study evaluated the efficacy and safety of bofanglutide injection in adult participants who had inadequate weight control despite lifestyle interventions and had either a BMI > 30 kg/m^², or a BMI ≥ 27 kg/m^² accompanied by weight-related comorbidities (excluding type 2 diabetes). Participants were randomized to receive bofanglutide injection 24 mg, 36 mg, or 48 mg Q2W or placebo, or 15 mg of tirzepatide injection once weekly for 36 weeks (including a dose-escalation phase).

After 36 weeks of treatment, among participants with overweight/obesity without type 2 diabetes, the bofanglutide 48 mg Q2W achieved a mean body weight reduction of 15.18%, with no weight loss plateau observed; the mean body weight reduction of 15 mg tirzepatide injection group was 16.93%. Bofanglutide injection also demonstrated significant improvements in cardiovascular and metabolic parameters, including blood pressure, waist circumference, and serum uric acid levels. The most common adverse events were gastrointestinal reactions, including nausea, vomiting, and diarrhea; these events were generally mild and transient, and no new safety signals were identified.

The above topline results are based on analyses of the Per-Protocol set (PPS).

Professor Linong Ji, Principal Investigator of the GRADUAL-1 Study and Professor at Peking University People's Hospital, commented: "As a chronic disease with a rapidly increasing prevalence, obesity prevention and management have become a major public health priority. Current clinical evidence suggests that the weight-loss efficacy of GLP-1 receptor agonists is closely associated with dose intensity, while extended dosing intervals may help improve treatment convenience and support long-term adherence. The development of therapies with longer dosing intervals may therefore represent an important advancement in obesity management. My research team and I are delighted that the GRADUAL-1 study successfully met its primary endpoint. Administered once every two weeks, Bofanglutide injection demonstrated robust weight loss efficacy, a favorable safety profile, and multifaceted metabolic benefits. We look forward to the successful submission of bofanglutide injection for market approval, providing a convenient, flexible, and sustainable treatment option for obesity management in China and supporting long-term weight management."

Dr. Wei Chen, Chairman and CEO of Gan & Lee Pharmaceuticals, said: "As China's first domestically developed biweekly GLP-1 receptor agonist, bofanglutide injection has demonstrated promising potential in weight management. To support its development and potential commercialization, Gan & Lee has initiated seven Phase III clinical studies, including the GRADUAL program, covering Chinese populations with obesity or overweight, type 2 diabetes and obesity combined with moderate-to-severe obstructive sleep apnea (OSA), systematically evaluating the efficacy and safety of biweekly bofanglutide injection.

Currently, both the pivotal Phase 3 weight-loss study GRADUAL-1 conducted in China and the Phase 2 weight-loss study conducted in the United States have delivered positive topline results. These results provide strong support for the continued development of bofanglutide injection in the management of overweight and obesity. Compared with currently available once-weekly formulations, the biweekly dosing regimen of Bofanglutide injection not only simplifies the treatment process, reduces the annual injection frequency by 50%, and enhances treatment flexibility, but also helps improve long-term treatment adherence among patients. We believe this more convenient treatment regimen has the potential to provide people living with overweight/obesity with an optimized, sustainable weight management option, contributing to better health outcomes and quality of life."

Bofanglutide injection has garnered repeated recognition within academic and industry for its outstanding research data. Results from previously completed early-stage weight-loss clinical studies of bofanglutide injection have been published in leading international journals, including Signal Transduction and Targeted Therapy, a Nature portfolio journal with a 2025 impact factor of 52.7, and Cell Reports Medicine, a Cell Press journal.

Detailed results from these two clinical studies are scheduled to be presented at scientific conferences this year and published in international academic journals. Results from other ongoing Phase III clinical studies of bofanglutide injection are expected to be released sequentially over the next year.

About the GRADUAL Clinical Development Program

The GRADUAL series of studies are large-scale Phase III clinical studies of Bofanglutide injection for the treatment of obesity or overweight, designed to comprehensively evaluate the therapeutic efficacy and safety of Bofanglutide injection in overweight and obese populations. Currently, three GRADUAL studies are ongoing in China, with a planned enrollment of more than 1,000 adults with obesity or overweight.

GRADUAL-1 Study: A 52-week study evaluating the weight-loss efficacy and safety of bofanglutide injection in 640 Chinese adults with obesity or overweight who had inadequate weight control despite diet and exercise;

GRADUAL-2 Study: A 52-week study evaluating the weight-loss efficacy and safety of bofanglutide injection compared to Semaglutide (Wegovy^® 2.4 mg) in 477 adults with obesity or overweight (including those with type 2 diabetes) who had inadequate weight control despite diet and exercise;

GRADUAL-3 Study: A 24-week extension study exploring the effects on weight and the safety of once-monthly bofanglutide injection.

About Bofanglutide 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).

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 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.