Sinotau is pleased to announce that the Investigational New Drug (IND) application for XTR021, a Class 1 innovative radiopharmaceutical developed in-house, has been accepted by the National Medical Products Administration (NMPA).
XTR021 is a 177Lu-labeled, PSMA-targeted radioligand for the treatment of prostate cancer.
Preclinical studies demonstrate that, owing to its novel molecular design, XTR021 exhibits higher cellular internalization and retention, as well as improved tumor uptake, compared with 177Lu-PSMA-617. Notably, XTR021 achieves superior tumor inhibition at significantly lower doses than 177Lu-PSMA-617.
Interim data from an investigator-initiated trial (IIT) in patients with metastatic castration-resistant prostate cancer (mCRPC) indicate a favorable safety profile, with no observed Grade 3 or higher adverse events or salivary gland toxicity. In terms of efficacy, XTR021 demonstrates a rapid and encouraging PSA50 response rate. Based on cross-trial comparisons, currently available data suggest that XTR021 may offer enhanced therapeutic efficacy and an improved safety profile relative to comparable international compounds, underscoring its potential as a next-generation radioligand therapy for prostate cancer.
Abbreviations: PSMA, prostate-specific membrane antigen; PSA, prostate-specific antigen; mCRPC, metastatic castration-resistant prostate cancer.