BST001 Deuterated Glucose Tracer Receives NMPA Clinical Trial Approval; Clinical Research Officially Underway
The company has obtained the NMPA Drug Clinical Trial Approval Notice, as the world’s first deuterated glucose molecular tracer advances into the clinical research stage.
On September 1, 2026, Biosotop formally received the Drug Clinical Trial Approval Notice for its lead product, the BST001 deuterated glucose molecular tracer, issued by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This marks that the product has been approved to commence clinical trials and has fully advanced from the regulatory communication stage into a new phase of clinical investigation and real-world translational implementation. Following the earlier submission of the pre-IND meeting application, this approval represents another key milestone for BST001 along its regulatory pathway.
As the world’s first deuterated glucose molecular tracer to receive NMPA clinical trial approval, BST001 leverages ²H magnetic resonance spectroscopy imaging (DMI) technology to noninvasively and specifically track glucose metabolism within human tissues—with a particular focus on aberrant lactate metabolism in tumor core regions—providing direct metabolic imaging evidence for early tumor screening, malignancy grading, and monitoring of targeted-therapy response.
This approval not only signifies regulatory recognition of BST001’s development pathway, but also lays a solid foundation for expanding deuterated glucose molecular tracers into more tumor types and indications, accelerating the translation of this technology from bench to bedside.
Drug Clinical Trial Approval Notice (Acceptance No. CXHL2600747; issued by the NMPA Center for Drug Evaluation, September 1, 2026)
Center for Drug Evaluation (CDE), NMPA — “Clinical Trial Implicit Approval” public listing