“Illuminate cancer, Precision surgery” – China’s First-in-class Near-Infrared Tumor-Targeted Fluorescent Contrast Agent Clinical Trial Approved by CDE!

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First-in-class near-infrared tumor-targeted fluorescentcontrast agent clinical trial has been approved, filling a gap in this field within China!

On May 21, 2024, in Suzhou, China, SIGNDOBiotechnology, a company dedicated to the R&D and industrialization of tumor-targeted fluorescent contrast agents with the goal of “Illuminate cancer, Precision surgery”, announced that the clinical trial application for its self-developed and proprietary near-infrared tumor-targeted fluorescent contrast agent (DGPR1008 Injection) has received tacit approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China (Acceptance Number: CXHL2400243). This product is intended for use in surgical patients with prostate cancer as an diagnostic adjunct for intraoperative identification of malignant lesions.

Currently, only On Target Laboratories and Lumicell Inc. in the United States have similar products approved globally. However, this field has remained uncharted in China. The approval of DGPR1008 for clinical trials brings us one step closer to delivering this innovative product to patients worldwide.

About Prostate Cancer

Prostate cancer is an epithelial malignancy that occurs in the prostate and is the most common malignancy of the male genitourinary system. According to the 2020 WHO Global Cancer Statistics report, the incidence and mortality rates of prostate cancer in China rank fourth and ninth among various malignant tumors respectively, and these rates are rapidly increasing. The National Cancer Center's nationwide cancer report indicated that the incidence of prostate cancer was 18.61 per 100,000 people with a recurrence rate as high as 40-50% in 2022, largely due to positive margins and/or metastatic lymph nodes.

About DGPR1008 Injection

DGPR1008 Injection is administered intravenously before surgery and enables precise intraoperative imaging of tumor, illuminating tumor cells in real-time. It offers advantages such as "high sensitivity, strong specificity, and a favorable tumor-to-background ratio (TBR)," which assists surgeons in clearly locating the tumor, visualizing its boundaries, and identify tumor margins. This significantly reduces damage to normal tissues and also aids in identifying occult tumour lesions and metastatic lymph nodes.

The founder said

With hope in our hearts, we pursue the light

Jing Zhao, founder and CEO of SIGNDOBiotechnology, said: "The IND application for SIGNDO Biotech DGPR1008 Injection receiving implied approval from the CDE is a significant milestone for the company. Moving forward, the company will enter a new phase of development. We will rapidly advance the multicenter clinical trials for DGPR1008 Injection and continue the research and development of other pipeline products such as DGPR2002, DGPR3006, and DGPR8002, contributing more to the innovative development and industrial progress of targeted fluorescent imaging agents in China."

About SIGNDO

SIGNDO Biotechnology is an innovative biotechnology company specializing in theR&D, as well as the industrialization of tumor-targeted fluorescent contrast agents and related products. SinceSIGNDO Biotech founding in 2021, our team has been dedicating to providing doctors with tools required for tumor visualization.Goal of "Illuminate Cancer, Precision Surgery ", SIGNDO Biotechcommitted to help surgeons achieve a more complete surgical resection and help improve patient outcomes.Real-time Targeted Fluorescent Conjugate（RTTFC^®）technology platformis a leading global technology platform, which can utilize small molecule fluorescence conjugate technology to build a multi-cancer product portfolio forintraoperative visualization of tumorsby surgeons.