Yantai Dongcheng Pharma’s 177Lu-LNC1003 Cleared for US FDA Phase I Study

China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase I clinical study for its drug 177Lu-LNC1003. This marks a significant milestone for the company as it advances its innovative treatment for advanced prostate cancer.

177Lu-LNC1003: A Novel Radioactive Therapeutic Agent Targeting PSMA
177Lu-LNC1003 is a radioactive in vivo therapeutic drug that targets the prostate-specific membrane antigen (PSMA), a protein highly expressed in prostate cancer and its metastatic cells. The drug is designed for the treatment of advanced prostate cancer with PSMA expression. Currently, there is no similar product available either domestically or internationally, highlighting the potential impact of this drug on the treatment landscape.

PSMA as a Target for Prostate Cancer Treatment
PSMA, a type II glutamate peptidase secreted by prostate epithelial cells, serves as a specific marker for prostate cancer. 177Lu-LNC1003 has demonstrated high binding affinity and PSMA targeting specificity in both in vivo and in vitro animal experiments, as well as in investigator-initiated trials (IITs). This suggests a promising approach to selectively target and treat prostate cancer cells.-Fineline Info & Tech

Fineline Info & Tech