Beijing, China, December 30, 2024 – Gan & Lee Pharmaceuticals (hereafter referred to as "Gan & Lee," stock code: 603087.SH) announced that the first participant has been successfully dosed in a Phase 3 clinical trial (GRADUAL-1) of Bofanglutide (research code: GZR18), a glucagon-like peptide-1 receptor agonist (GLP-1RA) bi-weekly formulation independently developed Gan & Lee, in Chinese partcipants with overweight or obesity. This marks the formal initiation of the first GLP-1 RA biweekly formulation for the indication of overweight or obesity into Phase 3 clinical development globally.

This Phase 3 clinical trial was designed to evaluate the efficacy and safety of Bofanglutide injection in Chinese adults with overweight or obesity whose weight was inadequately controlled by diet and exercise (ClinicalTrials.gov registration number: NCT06728124). The study plans to enroll 630 subjects who will be randomly assigned to receive treatment of either 24 mg of Bofanglutide bi-weekly, 48 mg of Bofanglutide bi-weekly, or placebo. The primary endpoints include the percentage change in body weight from baseline and the proportion of subjects with 5% or more body weight loss from baseline.

Previously, a Phase 2 study (NCT06256562) of Bofanglutide injection in Chinese subjects with overweight or obesity showed that after 30 weeks of treatment, the mean percentage in boday weight reduction from baseline was ?14.3% in the bi-weekly 24 mg group and ?17.3% in the bi-weekly 48 mg group. Additionally, Bofanglutide significantly reduced waist circumference and BMI, improved cardiovascular and glucose metabolism indicators, and demonstrated good safety and tolerability, with a safety profile similar to other GLP-1 receptor agonists.

Professor Linong Ji from Peking University People's Hospital, the leading principal investigator of the GRADUAL-1 study, stated, "Obesity has become a critical global public health issue and is rapidly spreading in China. According to Chinese standards, nearly half of the population is currently in the obesity (BMI ≥28 kg/m2) or overweight (24 kg/m2 ≤ BMI <28 kg/m2) condition. By 2030, this proportion is expected to rise to 63%1. Obesity is not only a significant risk factor for diabetes and cardiovascular diseases but also places a substantial economic burden on society. Currently, many weight-loss medications require frequent injections, causing inconvenience to patients who generally prefer oral medications or therapies with lower dosing frequencies. Bofanglutide, as a bi-weekly GLP-1 RA, demonstrated remarkable weight-loss efficacy in Phase 2 clinical trials, along with improvements in fasting blood glucose, blood pressure, lipids, and other metabolic indicators, as well as overall safety and tolerability. I look forward to further confirming the efficacy and safety of Bofanglutide in Phase 3 trials to provide robust evidence for its market approval."

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.