GCP-006

GCP-006 is an activatable fluorescent probe developed by GORYO Chemical, in collaboration with Solasia Pharma (where it is known as SP-05), for use in fluorescence image-guided surgery for breast cancer. The probe is designed to be specifically activated by an undisclosed intracellular enzyme that is highly expressed in breast cancer cells. Upon enzymatic cleavage, the probe emits a fluorescent signal, allowing surgeons to visualize cancer tissue in real-time during procedures such as breast-conserving surgery and sentinel lymph node biopsy. In March 2023, GORYO Chemical submitted a manufacturing and marketing approval application for GCP-006 in Japan. In February 2024, the company received a De Novo classification opinion from the U.S. FDA, indicating its regulation as a medical device in the United States.