CSPC Pharmaceutical Group Limited (01093) has announced that the Group presented the positive results of a Phase III clinical study of its glucagon-like peptide-1 (GLP-1) receptor agonist, Edaglutide Alfa Injection (TG103 Injection), combined with metformin for the treatment of Chinese adult patients with type 2 diabetes mellitus (T2DM), in a short oral discussion format at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD 2026).

The study results demonstrated that TG103 Injection exhibited favorable efficacy and safety in this patient population. The study was a multicenter, randomized, open-label, active-controlled Phase III clinical trial led by Professor Ji Linong from Peking University People's Hospital, using dulaglutide as the comparator, designed to evaluate the efficacy and safety of different doses of TG103 Injection in T2DM patients with inadequate glycemic control on metformin monotherapy.

The study enrolled patients aged 18 to 75 years who had received a stable dose (greater than or equal to 1500 mg per day) of metformin monotherapy for at least 8 weeks prior to screening but still had inadequate glycemic control, and who had a glycated hemoglobin (HbA1c) level between 7.0% and 10.5% at randomization. A total of 632 patients were enrolled and randomly assigned to three treatment groups, receiving once-weekly TG103 Injection 7.5 mg (n=210), TG103 Injection 15 mg (n=211, with 7.5 mg administered for the first 4 weeks followed by escalation to 15 mg), or dulaglutide 1.5 mg (n=211), for 28 consecutive weeks.

After Week 28, the dosage for patients in the TG103 Injection 7.5 mg group was adjusted to 15 mg, while the treatment regimens for the TG103 Injection 15 mg group and the dulaglutide 1.5 mg group remained unchanged, with all groups continuing treatment through Week 52. At this conference, the Group presented the positive results of the study, with the relevant efficacy and safety data as follows: In terms of efficacy, at Week 28, both the TG103 Injection 7.5 mg group and the TG103 Injection 15 mg group demonstrated clinically meaningful HbA1c reductions, with the TG103 Injection 15 mg group achieving a 1.38% decrease in HbA1c from baseline.

Based on a treatment strategy analysis more closely aligned with real-world clinical practice, the 28-week HbA1c reductions in all TG103 Injection dose groups were non-inferior to the dulaglutide 1.5 mg group. During the treatment period, all TG103 Injection dose groups showed rapid onset of action, with effects observed from Week 4 onward, and HbA1c reductions of greater than or equal to 1% after 8 weeks of treatment, with the reduction in the TG103 Injection 15 mg group sustained steadily through Week 52 without attenuation. At Week 52, the HbA1c reduction in the TG103 Injection 15 mg group was numerically higher than that in the dulaglutide 1.5 mg group (1.31% vs 1.25%), while the HbA1c reduction in the TG103 Injection 7.5 mg group at Week 52 was comparable to that of the dulaglutide 1.5 mg group.

Additionally, at both Week 28 and Week 52, the proportion of patients achieving HbA1c less than 7.0% in the TG103 Injection 15 mg group was higher than in the dulaglutide 1.5 mg group (Week 28: 53.9% vs 52.2%; Week 52: 52.2% vs 46.8%). In terms of safety, the safety profiles of the TG103 Injection 7.5 mg group, the TG103 Injection 15 mg group, and the dulaglutide 1.5 mg group were generally similar, with the primary adverse events being gastrointestinal events, the incidence of which was comparable across all groups, indicating that TG103 Injection has a favorable safety and tolerability profile.

The incidence of hypoglycemia and the rate of treatment discontinuation due to adverse events were relatively low in all TG103 Injection dose groups, and no severe hypoglycemic events were reported. TG103 Injection (7.5 mg and 15 mg) demonstrated rapid onset with stable and durable glycemic improvement, with significant efficacy observed as early as Week 8, glycemic reduction stabilizing by Week 12, and maintained through Week 52 without attenuation. Furthermore, with a simple and rapid dose-escalation scheme, TG103 Injection still exhibited a favorable safety and tolerability profile, with a low incidence of gastrointestinal adverse events.

The study results indicate that for T2DM patients with inadequate glycemic control on metformin monotherapy, TG103 Injection represents a combination treatment option with promising clinical application prospects.