BST001 Deuterated Glucose Tracer Submits Pre-IND Application
The company has submitted a pre-IND application to the NMPA, advancing clinical registration of the world's first deuterated glucose molecular tracer.
Biosotop has officially submitted a pre-IND meeting application for its core product, the BST001 deuterated glucose molecular tracer, to the Center for Drug Evaluation of China's National Medical Products Administration (NMPA). This marks the product's entry into the critical sprint phase of clinical registration.
BST001 is the world's first stable-isotope tracer drug to enter a standardized registration path. Using ²H magnetic resonance spectroscopic imaging, it specifically captures glucose metabolic trajectories in human tissue — particularly abnormal lactate metabolism in tumor cores — providing direct metabolic evidence for tumor early screening, malignancy grading and targeted-therapy efficacy monitoring.
“Moving from research exploration to standardized clinical practice is a major step in the history of stable-isotope technology,” said Ruan Yingheng, co-founder and Executive President of Biosotop. “We have accumulated hundreds of exploratory clinical cases, and the sensitivity and specificity for complex tumors such as glioma are exciting. We will work closely with regulators to obtain clinical approval as soon as possible and benefit patients.”