CSPC PHARMA (01093.HK): Efmedaglutide Alfa Phase III Data at EASD 2026
- The Phase III study is a multicentre, randomised, open-label, dulaglutide-controlled trial led by Professor Ji Linong of Peking University People's Hospital, enrolling 632 patients randomised to once-weekly TG103 Injection 7.5mg (n=210), 15mg (n=211) and dulaglutide 1.5mg (n=211), with treatment up to Week 52.
- At Week 28, the HbA1c level in the 15mg group decreased by 1.38% from baseline and the reduction in each dose group was non-inferior to dulaglutide 1.5mg; the reduction was at least 1% from Week 8 and stably sustained through Week 52 at 1.31% versus 1.25% for dulaglutide 1.5mg.
- The safety profiles were generally similar, with gastrointestinal events as the primary adverse events and comparable incidence rates; hypoglycaemia and discontinuation rates were relatively low, with no severe hypoglycaemic events reported.
NewTimeSpace News: On 30 September 2026, CSPC Pharmaceutical Group Limited (stock code: 01093.HK) announced on a voluntary basis that the Group presented, in a short oral discussion at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD 2026), the positive results of the Phase III clinical study of Efmedaglutide Alfa Injection (TG103 Injection), its glucagon-like peptide-1 (GLP-1) receptor agonist, in combination with metformin in Chinese adult patients with type 2 diabetes mellitus (T2DM).
The study is a multicentre, randomised, open-label, dulaglutide-controlled Phase III clinical trial led by Professor Ji Linong of Peking University People's Hospital, aimed at evaluating the efficacy and safety of different doses of the TG103 Injection in T2DM patients with inadequate glycaemic control on metformin monotherapy. A total of 632 patients were enrolled and randomly assigned to three treatment groups receiving once-weekly TG103 Injection 7.5mg (n=210), TG103 Injection 15mg (n=211) and dulaglutide 1.5mg (n=211) respectively for 28 weeks of continuous administration; after Week 28, the dose for the 7.5mg group was adjusted to 15mg, with all groups continuing treatment up to Week 52.
At Week 28, the HbA1c level in the TG103 Injection 15mg group decreased by 1.38% from baseline, and the reduction in HbA1c at Week 28 for each dose group was non-inferior to that in the dulaglutide 1.5mg group. All dose groups showed a rapid onset of action, with reductions in HbA1c of at least 1% after 8 weeks of treatment, and the reduction in the 15mg group was stably sustained without attenuation through Week 52, reaching 1.31% versus 1.25% for dulaglutide 1.5mg. The safety profiles of the groups were generally similar, with gastrointestinal events as the primary adverse events and comparable incidence rates; the incidence of hypoglycaemia and the discontinuation rate due to adverse events were relatively low, and no severe hypoglycaemic events were reported. The product is a recombinant human GLP-1 Fc fusion protein injection administered once weekly.
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