Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for HRS-9815 Radiodiagnostic Drug Clinical Study

Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a China-based pharmaceutical company, has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its injectable HRS-9815 and the accompanying preparatory kit. The product candidate is an in-house developed Category 1 radiodiagnostic drug.

HRS-9815: A Radiodiagnostic Drug for Prostate Cancer Detection
HRS-9815 is labeled as radioactive Gallium trichloride [68Ga] solution, specifically designed for positron emission tomography (PET) imaging of prostate specific membrane antigen (PSMA) positive lesions in adult prostate cancer patients. The drug is intended for use in suspected metastatic patients who plan to undergo radical treatment, suspected recurrent patients with elevated levels of prostate specific antigen (PSA), and for screening metastatic prostate cancer patients who are suitable for receiving lutetium [177Lu] – PSMA targeted radioligand therapy. Notably, there is no similar variety of the drug that has been approved for listing either domestically or internationally, highlighting the potential significance of HRS-9815 in the field of nuclear medicine and oncology.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry