VOLUNTARY ANNOUNCEMENT - RESULTS OF PHASE III CLINICAL STUDY OF EFMEDAGLUTIDE ALFA INJECTION IN COMBINATION WITH METFORMIN IN CHINESE ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS PRESENTED IN A SHORT ORAL DISCUSSION AT THE 62ND ANNUAL MEETING OF THE EUROPEAN ASSOCIATION FOR THE STUDY OF DIABETES (EASD 2026)
2026-09-30 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗
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CSPC PHARMACEUTICAL GROUP LIMITED (Incorporated in Hong Kong with limited liability) (Stock Code: 1093) ʮ ̡ VOLUNTARY ANNOUNCEMENT RESULTS OF PHASE III CLINICAL STUDY OF EFMEDAGLUTIDE ALFA INJECTION IN COMBINATION WITH METFORMIN IN CHINESE ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS PRESENTED IN A SHORT O RAL DISCUSSION AT THE 62ND ANNUAL MEETING OF THE EUROPEAN ASSOCIATION FOR THE STUDY OF DIABETES (EASD 2026) The Board of Directors (the ‘‘Board ’’) of CSPC Pharmaceutical Group Limited (the ‘‘Company ’’, together with its subsidiaries, the ‘‘Group ’’) is pleased to announce that the Group has presented the positive results of the Phase III clinical study (the ‘‘Study ’’) of the glucagon-like peptide-1 ( ‘‘GLP-1 ’’) receptor agonist Efmedaglutide Alfa Injection (the ‘‘TG103 Injection ’’) developed by the Group, in combination with metformin, for the treatment of Chinese ad ult patients with type 2 diabetes mellitus (‘‘T2DM ’’) in a short oral discussion at the 62nd Annual Meeting of the E uropean Association for the Study of Diabetes (EASD 2026). The results of the Study demon strated that the TG103 Injection exhibited a favourable efficacy and safety profile in this p opulation. Study Design The Study is a multicentre, randomised, open-label, dulagl utide-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 wi th inadequate glycaemic control on metformin monotherapy. The Study enrolled T2DM patients aged 18 to 75 years who had re ceived a stable dose ( ≥1,500 mg/day) of metformin monotherapy for at least 8 weeks prior to screen ing but still had inadequate glycaemic control, and whose glycated haemoglobin ( ‘‘HbA1c ’’) levels were between 7.0% and 10.5% prior to randomisation. – 1 – A total of 632 patients were enrolled in the Study and randoml y assigned to three treatment groups to receive once-weekly TG103 Injection 7.5 mg (n=210), TG103 I njection 15 mg (n=211; administered at 7.5 mg for the first 4 weeks, followed by escalation to 15 mg), and dulaglutide 1.5 mg (n=211), respectively, for 28 weeks of continuous administration. A fter Week 28, the dose for patients in the TG103 Injection 7.5 mg group was adjusted to 15 mg, while the t reatment regimens for the TG103 Injection 15 mg group and the dulaglutide 1.5 mg group remain ed unchanged, with continuous administration up to Week 52 for all groups. Study Results At the meeting, the Group presented the positive results of t he Study. The relevant efficacy and safety data are as follows: . Efficacy At Week 28, both the TG103 Injection 7.5 mg group and the TG103 Injection 15 mg group demonstrated a clinically meaningful reduction in HbA1c, w ith the HbA1c level in the TG103 Injection 15 mg group decreasing by 1.38% from baseline. Bas ed on the treatment policy strategy analysis, which more closely reflects clinical practice sc enarios, the reduction in HbA1c at Week 28 for each dose group of TG103 Injection was non-inferior to that in the dulaglutide 1.5 mg group. During the treatment period, all dose groups of TG103 Inject ion showed a rapid onset of action, taking effect as early as Week 4 of treatment, with reduction s in HbA1c of ≥1% after 8 weeks of treatment. Notably, the reduction in the TG103 Injection 15 mg group was stably sustained without attenuation through Week 52. At Week 52, the numerical reduc tion in HbA1c in the TG103 Injection 15 mg group was higher than that in the dulaglutide 1.5 mg group (1.31% vs 1.25%), while the reduction in HbA1c in the TG103 Injection 7.5 mg gro up was comparable to that in the dulaglutide 1.5 mg group at Week 52. In addition, at both Week 28 and Week 52, the proportion of pat ients achieving HbA1c 57.0% in the TG103 Injection 15 mg group was higher than that in the dul aglutide 1.5 mg group (Week 28: 53.9% vs 52.2%; Week 52: 52.2% vs 46.8%). . Safety The safety profiles of the TG103 Injection 7.5 mg group, the T G103 Injection 15 mg group and the dulaglutide 1.5 mg group were generally similar. The primar y adverse events were gastrointestinal events, with comparable incidence rates across the groups, indicating that TG103 Injection has a favourable safety and tolerability profile. The incidence of hypoglycaemia and the discontinuation rate due to adverse events in all dose groups of TG103 Injecti on were relatively low, and no severe hypoglycaemic events were reported. – 2 – Study Conclusions TG103 Injection (7.5 mg and 15 mg) demonstrated a rapid onset of action and a stable, durable glycaemic improvement effect, with significant efficacy o bserved as early as Week 8. The glucose- lowering effect tended to stabilise by Week 12 and was mainta ined without attenuation up to Week 52. Concurrently, under a simple and rapid dose escalation regi men, TG103 Injection continued to exhibit a favourable safety and tolerability profile, with a relativ ely low incidence of gastrointestinal adverse events. The results of the Study indicate that, for T2DM pati ents with inadequate glycaemic control on metformin monotherapy, TG103 Injection represents a combi nation treatment option with promising clinical application prospects. About TG103 Injection TG103 Injection is a recombinant human glucagon-like pepti de-1 (hGLP-1) Fc fusion protein injection administered once weekly. The product can selectively bind to and activate GLP-1 receptors, promoting insulin secretion and inhibiting glucagon release in a gluc ose concentration-dependent manner, thereby steadily lowering blood glucose levels. Additionally, TG1 03 Injection can suppress appetite, reduce food intake, and exert weight-regulating effects while als o improving cardiovascular and metabolism- related indicators. By Order of the Board CSPC Pharmaceutical Group Limited CAI Dong Chen Chairman Hong Kong, 30 September 2026 As at the date of this announcement, the Board comprises Mr. C AI Dong Chen, Dr. CAI Lei, Mr. WEI Qingjie, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Dr. LI Chunlei , Dr. YAO Bing, Mr. CAI Xin, Mr. CHEN Weiping, Mr. QU Zhiyong and Mr. ZHANG Yiwei as Executive Directors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan, M r. LAW Cheuk Kin Stephen and Ms. LI Quan as Independent Non-executive Directors. – 3 –
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