Beijing, China, February 27, 2026 — Gan & Lee Pharmaceuticals (hereinafter "Gan & Lee", stock code: 603087.SH) announced that the results of Phase 2b clinical study of bofanglutide (GZR18) injection, an investigational bi-weekly (once every two weeks, Q2W) glucagon-like peptide-1 receptor agonist (GLP-1 RA), in Chinese adults with overweight or obesity have been published in the Signal Transduction and Targeted Therapy (STTT). STTT is a globally recognized and authoritative academic journal with an impact factor of 52.7 in 2025, and has established a strong reputation in the biomedical field. As a potentially first bi-weekly GLP-1 RA worldwide, the study results of bofanglutide injection demonstrated significant body-weight reduction, with comprehensive improvements in cardiometabolic and metabolic parameters.

Study Design

This study was a randomized, double-blind, placebo-controlled Phase 2b clinical study conducted across 20 research sites in China. A total of 340 Chinese adults with overweight or obesity were enrolled. Participants were randomly assigned to five dose groups: 12 mg Q2W, 18 mg Q2W, 24 mg Q2W, 48 mg Q2W, and 24 mg once weekly (QW), with randomization to bofanglutide or placebo within each dose group. The total treatment duration was 30 weeks, comprising a dose-escalation period followed by a dose-maintenance period. The primary endpoint was the percentage change in body weight from baseline to week 30.

Study Results

Using the treatment policy estimand, the study results showed a significant reduction in body weight from baseline at week 30 in participants receiving different doses and dosing frequencies of bofanglutide, with weight loss not yet reaching a plateau. Key findings are as follows:

• In the bofanglutide Q2W dose groups, the mean percentage change in body weight from baseline exhibited a dose-dependent decrease: -9.75%, -12.55%, -13.66%, and -16.09% for the 12 mg, 18 mg, 24 mg, and 48 mg groups, respectively. The 24 mg QW group showed a reduction of 16.69%, whereas the placebo group decreased by 1.15%.

• There was no significant difference in body weight reduction between the 48 mg Q2W and 24 mg QW groups (one-sided test P>0.025), suggesting that biweekly dosing may reduce injection frequency and improve convenience while maintaining efficacy comparable to once-weekly dosing.

• The proportion of participants achieving weight loss targets in all bofanglutide groups were significantly higher than the placebo group. In the 48 mg Q2W group, the proportions of participants achieving ≥5%, 10%, 15%, and 20% weight loss were 96.8%, 82.7%, 61.5%, and 39.2%, respectively.

Furthermore, bofanglutide improved multiple cardiometabolic risk factors, including waist circumference, glycemic measures, blood pressure, blood lipid profiles and liver enzymes levels.

Overall, bofanglutide was safe and well tolerated, with a safety profile consistent with other GLP-1 RAs. The most common adverse events were mild to moderate gastrointestinal reactions. No treatment-related serious adverse events were reported during the study.

Article link: https://www.nature.com/articles/s41392-026-02586-8 

Professor Linong Ji, Peking University People's Hospital, the leading principal investigator of bofanglutide weight management study, stated,"This Phase 2b clinical study evaluated the efficacy and safety of bi-weekly bofanglutide injection in Chinese adults with overweight or obesity. The study result demonstrates that bofanglutide not only delivers significant body-weight reduction, but also improves glycemic control and multiple cardiovascular risk factors. Notably, bi-weekly bofanglutide achieved weight-loss efficacy comparable to once-weekly dosing of similar products. This innovative and more convenient dosing regimens reduces the injections frequency by 50% per year compared with weekly formulations, and may potentially enhance patient treatment adherence. Currently, the Phase 3 clinical trial of bofanglutide is progressing across 44 clinical research sites in China, with nearly 640 participants enrolled. This study will further validate the efficacy and safety of bofanglutide. The corresponding clinical data are expected to be released in the first half of 2026, providing additional objective and reliable evidence to support long-term weight management and comprehensive metabolic benefits with bofanglutide."

Dr. Jing Zhao, Head of Clinical Medicine Department, Gan & Lee Pharmaceuticals, stated, "The publication of the Phase 2b results of bofanglutide in a leading international journal reflects strong academic recognition of its clinical value and represents another significant milestone for China's innovation in drug development for chronic metabolic diseases. Bofanglutide has the potential to become the world's first bi-weekly GLP-1 RA. Gan & Lee is committed to innovation and to advancing high-quality development in China's weight-management therapeutics. Going forward, we will continue to accelerate the clinical development of bofanglutide. We aim to provide patients with more optimized and sustainable treatment options, support the goals of 'Healthy China 2030' and contribute China's efforts to the global response to obesity as a major public health challenge."

About Bofanglutide (GZR18)

Bofanglutide injection (research code: GZR18) is a novel GLP-1 RA developed by Gan & Lee Pharmaceuticals. Its clinical development currently focuses on two indications: obesity/overweight 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 that of marketed GLP-1 RAs, and it has the potential to become the world’s first approved biweekly GLP-1 RA. Currently, the global development of bofanglutide has advanced to the phase 3 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 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 has received marketing authorization from the European Commission (EC), while for insulin lispro injection and insulin aspart injection, it has received the positive opinion from CHMP of EMA. 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.