C-Ray Therapeutics Receives FDA Acceptance of Type II Drug Master File for Copper-64 (Cu-64)

DMF No. 43568 is now active and available for reference in global IND and NDA submissions

CHENGDU, China, April 28, 2026 /PRNewswire/ -- C-Ray Therapeutics (Chengdu) Co., Ltd., today announced that its Type II Drug Master File (DMF) for COPPER [64Cu] CHLORIDE FOR RADIOLABELLING has been listed as active by the U.S. Food and Drug Administration (FDA) under DMF No. 43568. The DMF is now available for reference by radiopharmaceutical developers worldwide in support of IND and NDA submissions.

Cu-64: The Next-Generation Diagnostic Radionuclide

Cu-64 offers a half-life of approximately 12.7 hours — significantly longer than the current standard diagnostic radionuclides Ga-68 (T₁/₂ = 68 min) and F-18 (T₁/₂ = 110 min). This extended half-life enables centralized large-scale production, shelf lives of up to 48 hours, and substantially reduced scheduling pressure at imaging centers, improving patient access to PET diagnostics.

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-labeled 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% (p < 0.0001). These advantages position Cu-64 as a leading candidate for next-generation diagnostic radiopharmaceuticals, with particular relevance in oncology indications including neuroendocrine tumors (NETs) and prostate cancer.

Proprietary Manufacturing Platform: Scale and Cost Efficiency

C-Ray Therapeutics has overcome key technical barriers in Cu-64 production through its proprietary manufacturing process and purpose-built, fully automated production facility. The company's in-house Ni-64 recycling process achieves a recovery rate of up to 90%, allowing recovered high-enrichment Ni-64 to be reused directly in subsequent production cycles. This enables stable, continuous multi-batch operation and substantially reduces raw material costs. Current batch capacity exceeds 2 Ci (end of bombardment, EOB).

C-Ray also offers integrated, end-to-end services encompassing radiolabeling and conjugation, formulation and fill-finish, and cold-chain distribution — a true one-stop solution for radiopharmaceutical developers.

"FDA acceptance of our Cu-64 Type II DMF marks a significant milestone that positions C-Ray Therapeutics as a regulatorily prepared and operationally validated supply partner for diagnostic radiopharmaceuticals," said Qiao Haitao, General Manager of C-Ray Therapeutics (Chengdu). "This achievement reflects our high standards in manufacturing, quality systems, and regulatory execution, and enables us to support partners from early-stage development through clinical and commercial phases."— Haitao Qiao, General Manager, C-Ray Therapeutics

Strategic Significance

The FDA acceptance of the Cu-64 DMF validates the robustness of C-Ray's proprietary manufacturing process, quality systems, and regulatory controls. For domestic biopharmaceutical companies developing Cu-64-based diagnostic agents, this DMF significantly lowers the CMC burden and reduces compliance risk in FDA IND and NDA submissions.

For multinational pharmaceutical companies and global radiopharmaceutical developers, it establishes a reliable, compliant, high-quality Cu-64 supply source from China to support clinical development and registration strategies worldwide. Looking ahead, C-Ray Therapeutics will continue to strengthen its full-chain service capabilities and collaborate with partners across the globe to advance theranostics and expand patient access to precision nuclear medicine.

About C-Ray Therapeutics

C-Ray Therapeutics is a global CRDMO providing end-to-end radiopharmaceutical development services — from target validation and preclinical evaluation to IND-enabling studies, clinical supply, and commercial-scale cGMP manufacturing. Operating from its 28,000-square-meter Chengdu facility under China's Class A Radiation Safety License, C-Ray supports 30+ radioisotopes and has delivered 100+ projects spanning diagnostic and therapeutic programs, including 5 programs at IND or IND-enabling stage, 7 in clinical supply, and 2 in Phase III clinical trials. For more information, visit www.c-raytherapeutics.com

SOURCE C Ray Therapeutics