Chinese biopharmaceutical company C-Ray Therapeutics (Chengdu) Co Ltd announced on Tuesday that its Type II Drug Master File (DMF) for COPPER [64Cu] CHLORIDE FOR RADIOLABELLING has been listed as active by the US Food and Drug Administration (FDA) under DMF No. 43568.

The company says that the DMF is now available for reference by radiopharmaceutical developers worldwide in support of IND and NDA submissions.

Cu-64 offers a half-life of approximately 12.7 hours, and this extended half-life enables centralised large-scale production, shelf lives of up to 48 hours, and substantially reduced scheduling pressure at imaging centres, improving patient access to PET diagnostics.

According to C-Ray, clinical validation of Cu-64 is well established. A 2026 study published in European Urology (IF 25.2) by Clarity Pharmaceuticals, evaluating Cu-64 SAR-bisPSMA (Co-PSMA) in patients with prostate cancer, demonstrated that Cu-64-labelled imaging agents detected more than twice as many lesions as Ga-68 PSMA-11: mean lesions detected per patient were 1.26 vs. 0.48, with a positive detection rate of 78% vs. 36%. These advantages position Cu-64 as a leading candidate for next-generation diagnostic radiopharmaceuticals, with particular relevance in oncology indications including neuroendocrine tumours (NETs) and prostate cancer.