C-Ray Therapeutics Gains FDA DMF Clearance for Cu-64, Positioning as Global Radiopharma Supply Partner

New updates have been reported about C Ray Therapeutics.

C-Ray Therapeutics has secured U.S. FDA activation of its Type II Drug Master File for COPPER [64Cu] CHLORIDE FOR RADIOLABELLING (DMF No. 43568), giving global radiopharmaceutical developers a ready-to-reference CMC backbone for IND and NDA filings. This moves C-Ray into a central role as a qualified Cu-64 supplier for clinical and commercial PET programs, lowering regulatory friction and accelerating timelines for partners targeting oncology indications.

Cu-64’s 12.7-hour half-life enables centralized large-scale production, up to 48-hour shelf life, and more flexible imaging schedules versus Ga-68 and F-18, which can materially ease logistics and expand patient access. Evidence from recent clinical work in prostate cancer, where Cu-64-labeled agents have more than doubled lesion detection versus Ga-68 comparators, supports C-Ray’s bet that Cu-64 will anchor next-generation diagnostic radiopharmaceuticals.

To monetize this shift, C-Ray has built a proprietary Cu-64 manufacturing platform with an automated facility and an in-house Ni-64 recycling process that recovers up to 90% of the enriched target material, enabling multi-batch continuity while structurally reducing isotope input costs. Current batch capacity above 2 Ci at end of bombardment provides a scalable base for both early-stage and late-stage supply, aligning with the needs of global clinical programs.

The FDA’s acceptance of the DMF effectively validates C-Ray’s manufacturing controls, quality systems, and regulatory capabilities, and allows U.S.-bound developers to reference the file instead of building Cu-64 CMC packages from scratch. For Chinese biopharma companies, this reduces compliance risk and cost in cross-border IND and NDA strategies, while multinational drug developers gain a pre-vetted Cu-64 source from China to support global trials.

Beyond isotope supply, C-Ray is positioning as a CRDMO partner with integrated radiolabeling, conjugation, formulation, fill-finish, and cold-chain distribution, aiming to capture more value across the theranostics value chain. Operating from a 28,000-square-meter cGMP site in Chengdu under a Class A Radiation Safety License, the company already supports more than 30 radioisotopes and over 100 programs, including multiple assets at IND, clinical supply, and Phase III stages, which provides a pipeline-driven demand base for its newly validated Cu-64 platform.

Management signals that the DMF milestone is both a commercial and strategic inflection point, elevating C-Ray from a regional supplier to a regulatorily prepared global partner for precision nuclear medicine. The company intends to leverage this regulatory asset to deepen collaborations with domestic and multinational sponsors, expand its theranostic services, and reinforce its role in the emerging Cu-64-based PET and radiotherapeutic ecosystem.