Landmark Achievement! Phase II Clinical Trial of Signdo Biotech’s DGPR1008 Injection Successfully Completed!_NEWS

Landmark Achievement! Phase II Clinical Trial of Signdo Biotech’s DGPR1008 Injection Successfully Completed!

Signdo Biotech (Suzhou) Co., Ltd. (“Signdo Biotech”) announced that the Phase II clinical trial of DGPR1008 Injection, an in-house developed near-infrared tumour-targeted fluorescent contrast agent with independent intellectual property rights, has been successfully completed at three top-tier Class A tertiary hospitals renowned for urology in China: the First Medical Center of Chinese PLA General Hospital, Renji Hospital, Shanghai Jiao Tong University School of Medicine, and The Affiliated Hospital of Qingdao University.The three institutions are domestic benchmarks in urology, leading cutting-edge technologies in the diagnosis and treatment of urological tumours, minimally invasive surgery and precision imaging diagnosis. Their robust specialist clinical platforms and extensive experience in oncology clinical trials have provided professional support for the smooth progression of this project.

The successful completion of patient enrolment in this Phase II clinical study represents a major milestone in the R&D journey of DGPR1008 Injection. It signals a new phase in the product’s clinical development and lays a solid foundation for the full launch of the subsequent Phase III clinical trial.

High Sensitivity · High Specificity

Chinese PLA General Hospital

This Phase II clinical trial was designed to evaluate the safety and intraoperative imaging efficacy of DGPR1008 Injection in patients with prostate cancer. Throughout the project, investigator teams at all study centres attached great importance to the trial and implemented protocols rigorously. The generation of every dataset and documentation of every case strictly complied with GCP guidelines and trial protocols to fully protect the rights and interests of subjects and guarantee high-quality research data.Thanks to careful oversight and full support from numerous professors and experts, the research team forged ahead steadily. With rigorous professionalism and strong execution, the team successfully achieved the target of complete patient enrolment.

Pooled multicentre clinical trial data demonstrate that during radical prostatectomy, near-infrared fluorescence imaging using DGPR1008 Injection achieves an overall average sensitivity of approximately 91.13% and a specificity of 94.60% for detecting prostate cancer tissue. The consistency rate with histopathological examination, the clinical gold standard, reaches 92.64%! The agent enables accurate identification of prostate cancer lesions and differentiation between tumour and normal tissue, with a high degree of consistency between imaging findings and pathological results, delivering outstanding clinical performance.

Efficient Collaboration · New Frontier for Targeted Therapy

Renji Hospital, Shanghai Jiao Tong University School of Medicine

As the company’s core candidate for prostate cancer, DGPR1008 Injection has exhibited promising application potential in earlier studies owing to its excellent tumour targeting capacity and precise intraoperative imaging capability.The successful conclusion of Phase II enrolment not only validates the feasibility of the product’s clinical development roadmap, but further attests to the company’s execution capacity and systematic capabilities in clinical research. Moving forward, the company will continue data sorting and statistical analysis of Phase II results, steadily prepare for and initiate the Phase III clinical trial, and fully accelerate the product development timeline, striving to deliver this innovative drug to broad populations of prostate cancer patients at the earliest opportunity.

Successful Trial Completion

The Affiliated Hospital of Qingdao University

From the first subject enrolment to full enrolment completion, every milestone stems from trust and perseverance. We sincerely appreciate the professional dedication of all investigators, the trust and support of all trial subjects and their families, and the diligent efforts of every member of the project team.New drug development is a long and challenging journey, yet progress awaits those who forge ahead. The successful completion of Phase II enrolment embodies Xindou Biotech’s persistent R&D vision: “Light up tumours for precise surgery”. The company will continue to advance subsequent clinical studies steadily, so that innovative achievements can benefit more patients as soon as possible.

Stay tuned for further clinical updates.

BACK

ABOUT

SCIENCE

NEWS