The 45th Congress of the Société Internationale d’Urologie (SIU 2025) was held in Edinburgh, Scotland. The conference focused on the latest research advances and technological achievements in global urology. During the event, Signdo Biotech unveiled clinical trial results of DGPR1008, its self-developed targeted fluorescent contrast agent for prostate cancer, for the first time.
Research Presentations
A professor from the Department of Urology, The Fourth Affiliated Hospital of Soochow University (Suzhou Dushu Lake Hospital) delivered an oral presentation at the congress, sharing key findings of DGPR1008.
The trial enrolled 14 prostate cancer patients with a Gleason score ≥7. No injection-related adverse events (AEs) associated with DGPR1008 were observed, demonstrating favourable safety and tolerability of DGPR1008. During intraoperative fluorescence imaging, DGPR1008 enabled precise delineation of tumour boundaries. In the optimal dose group, tumour detection sensitivity reached 90% in vivo and 100% ex vivo.
Notably, DGPR1008 helped researchers identify a metastatic lesion on the rectal surface in one subject. The lesion was undetectable on preoperative imaging, yet clearly visualised via intraoperative fluorescence imaging. Researchers resected the lesion and sent it for separate pathological examination. Pathology confirmed malignancy, consistent with the fluorescence-based judgement. These remarkable findings attracted great attention from experts in attendance.
Researchers from The Affiliated Hospital of Qingdao University also presented clinical trial data of DGPR1008 conducted at the hospital.
The PhaseⅠtrial recruited 32 healthy volunteers. No DGPR1008 injection-related AEs were recorded, further verifying the excellent safety and tolerability profile of DGPR1008.
The Phase Ⅱa trial enrolled 24 prostate cancer patients. DGPR1008 allowed clear intraoperative visualisation of tumour boundaries to guide resection margins. Additional tissue resection was performed in 19 patients. The agent achieved a margin detection sensitivity of 74.51% and specificity of 97.44%, with 100% sensitivity in identifying positive lymph nodes. It enhances the precision of prostate cancer surgery and helps prevent adverse reactions such as lymphoedema caused by excessive lymph node dissection. The results won high recognition from participating specialists.
The encouraging clinical data of DGPR1008 carry significant clinical value and bring new hope for improved postoperative quality of life for prostate cancer patients. Preparations are underway to advance DGPR1008 into Phase III clinical trials.
About Prostate Cancer
Prostate cancer is an epithelial malignancy originating in the prostate gland and one of the most common malignant tumours of the male urogenital tract. According to the WHO Global Cancer Observatory 2020 report, prostate cancer ranks fourth in incidence and ninth in mortality among all malignancies in China, with both indicators rising rapidly.National cancer registry reports from China’s National Cancer Center show that the incidence of prostate cancer stood at 18.61 per 100,000 people in 2022. The recurrence rate is as high as 40%–50%, largely attributable to positive surgical margins and/or metastatic lymph nodes.
About Signdo Biotech
Founded in February 2021, Signdo Biotech is an innovative biotechnology enterprise dedicated to the R&D and industrialisation of tumour-targeted fluorescent contrast agents and related products.Since its inception, the company has strived to provide surgeons with tumour visualisation tools. Guided by its vision “Light up tumours for precise surgery”, Signdo Biotech supports surgeons to achieve complete tumour resection and improves quality of life for cancer patients.Signdo Biotech owns the world-leading RT-TFC™ technology platform. By adopting small-molecule fluorescent conjugation technology, the company is building a multi-cancer product portfolio to enable real-time intraoperative tumour visualisation. The technology facilitates ultra-precise and minimally invasive surgery, aiming to set new benchmarks for oncological operations.
【Scan and follow us】
