C-Ray Therapeutics Secures FDA Approval for Copper-64 Drug Master File, Advancing Next-Generation PET Diagnostics
核心洞察
C-Ray Therapeutics (搜索) received FDA acceptance of its Type II Drug Master File for Copper-64 chloride, enabling global radiopharmaceutical developers to reference the filing in IND and NDA submissions.
Copper-64's 12.7-hour half-life significantly exceeds current diagnostic radionuclides Ga-68 and F-18, allowing centralized production and 48-hour shelf life for improved patient access.
Clinical validation shows Cu-64-labeled imaging agents detected more than twice as many lesions compared to Ga-68 PSMA-11 in prostate cancer patients (1.26 vs. 0.48 mean lesions per patient, p < 0.0001).
C-Ray Therapeutics (搜索) (Chengdu) Co., Ltd. announced that the U.S. Food and Drug Administration has accepted its Type II Drug Master File for COPPER [64Cu] CHLORIDE FOR RADIOLABELLING, marking a significant regulatory milestone for next-generation diagnostic radiopharmaceuticals. The DMF, designated as No. 43568, is now active and available for reference by radiopharmaceutical developers worldwide in support of Investigational New Drug and New Drug Application submissions.
Superior Half-Life Enables Operational Advantages
Copper-64 offers a half-life of approximately 12.7 hours, representing a substantial improvement over current standard diagnostic radionuclides Gallium-68 (T₁/₂ = 68 minutes) and Fluorine-18 (T₁/₂ = 110 minutes). 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.
The clinical validation of Cu-64 demonstrates compelling advantages in oncological applications. A 2026 study published in European Urology by Clarity Pharmaceuticals (搜索) evaluated Cu-64 SAR-bisPSMA (搜索) (Co-PSMA (搜索)) in patients with prostate cancer, showing that Cu-64-labeled imaging agents detected more than twice as many lesions as Ga-68 PSMA-11. The study reported mean lesions detected per patient of 1.26 versus 0.48, with positive detection rates of 78% versus 36% (p < 0.0001).
Proprietary Manufacturing Platform Addresses Technical Barriers
C-Ray Therapeutics (搜索) has developed a proprietary manufacturing process and purpose-built, fully automated production facility to overcome key technical barriers in Cu-64 production. 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 capability enables stable, continuous multi-batch operation and substantially reduces raw material costs, with current batch capacity exceeding 2 Ci (end of bombardment, EOB).
The company provides integrated, end-to-end services encompassing radiolabeling and conjugation, formulation and fill-finish, and cold-chain distribution, offering a comprehensive solution for radiopharmaceutical developers.
Regulatory and Strategic Impact
"FDA acceptance of our Cu-64 Type II DMF marks a significant milestone that positions C-Ray Therapeutics (搜索) 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."
The FDA acceptance 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 Chemistry, Manufacturing, and Controls burden and reduces compliance risk in FDA IND and NDA submissions.
For multinational pharmaceutical companies and global radiopharmaceutical developers, the approved DMF establishes a reliable, compliant, high-quality Cu-64 supply source from China to support clinical development and registration strategies worldwide. The positioning of Cu-64 as a leading candidate for next-generation diagnostic radiopharmaceuticals holds particular relevance in oncology indications including neuroendocrine tumors and prostate cancer.
C-Ray Therapeutics (搜索) plans to continue strengthening its full-chain service capabilities and collaborate with partners globally to advance theranostics and expand patient access to precision nuclear medicine.