EAU26 Highlight Presentation | Signdo Biotech’s DGPR1008 Injection Clinical Data Draws Global Attention

From March 13 to 16 local time, the 41st Annual Congress of the European Association of Urology (EAU26), a highly anticipated event for the global urology community, was grandly held in London, UK. As a top academic conference in worldwide urology, EAU26 brought together leading specialists across the globe to discuss cutting-edge breakthroughs and innovative advances in the diagnosis and treatment of urological diseases. Novel diagnostic and therapeutic technologies for prostate cancer stood out as one of the key themes at this year’s congress.

At the congress, Professor Yang Xuecheng from the Department of Urology, The Affiliated Hospital of Qingdao University was invited to deliver a high-impact presentation on the latest progress and core data from Phase I/II clinical trials of DGPR1008 Injection, independently developed by Signdo Biotech. He systematically presented the full clinical dataset spanning safety validation in healthy volunteers to intraoperative imaging evaluation in prostate cancer patients, showcasing the strength of Chinese innovative pharmaceuticals to global peers and offering new strategies for precision diagnosis and treatment of prostate cancer.
Phase I/II Clinical Data Released: Comprehensive Validation of Safety and Efficacy of DGPR1008
The pivotal Phase I/II data shared by Professor Yang fully demonstrated the safety and efficacy of the agent and validated its clinical potential from healthy subjects to patients.
Notably, robust core outcomes were observed in the Phase IIa trial, as detailed below. In Phase IIa studies, the positive predictive value (PPV) for tumour tissue reached 92.31% in the 0.02 mg/kg dose group and as high as 97.44% in the 0.04 mg/kg dose group. Furthermore, the agent achieved a resection margin sensitivity of 83.33% and 100% sensitivity for lymph node detection.
☆ Excellent safety profile: Consistent findings from Phase I and Phase II trials confirm favourable safety.
☆ Precise tumour targeting: Clear intraoperative near-infrared imaging delivers sharp contrast between tumour lesions and normal tissue, addressing the clinical challenge of indistinct tumour borders and residual disease encountered in conventional surgery.
☆ Reliable imaging performance: Favorable tumour-to-background ratio enables clinicians to identify tiny lesions effectively, substantially lowering the risk of residual tumour. The agent is expected to greatly improve patients’ postoperative quality of life.

Prominent Clinical Value: Innovation Drives Upgraded Precision Management of Prostate Cancer
Prostate cancer poses a major threat to men’s health globally, with an increasing incidence year by year. A subset of patients suffers from surgical residual disease and postoperative recurrence due to poorly defined tumour margins.
The Phase I/II clinical trials of DGPR1008 Injection have systematically verified its safety and efficacy. As China’s first near-infrared tumour-targeted fluorescent contrast agent approved for clinical trials, it features accurate targeting and dependable imaging performance. The candidate fills the domestic gap in this field and provides a more targeted new option for precision prostate cancer surgery worldwide. It is poised to shift prostate cancer surgery from experience-based practice to precision-guided treatment, bringing new hope to patients and highlighting the robust R&D capacity of Chinese innovative drugs.
Professor Yang Xuecheng stated that clinical research on DGPR1008 Injection is advancing vigorously. Going forward, he will continue to collaborate with Xindou Biotech to push forward further clinical investigations, accumulate comprehensive supporting data, accelerate the drug’s path to market access, benefit more prostate cancer patients, and contribute Chinese expertise to global prostate cancer care.