C-Ray Therapeutics Receives FDA Acceptance for Copper-64 Drug Master File, Advancing Radiopharmaceutical Development

Key Takeaways

• FDA accepts C-Ray Therapeutics’ Type II Drug Master File for Copper-64 chloride under DMF No. 43568
• Active DMF enables global radiopharmaceutical developers to reference the filing for IND and NDA submissions
• Development streamlines regulatory pathway for Copper-64 based diagnostic and therapeutic radiopharmaceuticals

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C-Ray Therapeutics (Chengdu) Co., Ltd. announced April 28, 2026, 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 the radiopharmaceutical industry.

Regulatory Milestone Achieved

The FDA has listed DMF No. 43568 as active, making it immediately available for reference by radiopharmaceutical developers worldwide. This acceptance enables companies developing Copper-64 based therapies to streamline their Investigational New Drug (IND) and New Drug Application (NDA) submissions by referencing C-Ray’s established manufacturing and quality data.

Impact on Radiopharmaceutical Development

Copper-64 represents a versatile radioisotope with applications in both diagnostic imaging and targeted radiotherapy. The isotope’s unique properties, including its 12.7-hour half-life and dual decay pathways, make it valuable for theranostic applications where the same compound can be used for both diagnosis and treatment.

The active DMF status eliminates the need for individual developers to submit comprehensive manufacturing data for Copper-64 chloride, potentially accelerating development timelines and reducing regulatory costs across the industry.

Market Implications

This regulatory acceptance positions C-Ray Therapeutics as a key supplier in the growing radiopharmaceutical market. The availability of an FDA-accepted DMF may encourage more companies to pursue Copper-64 based drug development, potentially expanding treatment options for cancer patients and other conditions requiring targeted radiotherapy.

The global radiopharmaceutical market continues expanding, driven by increasing cancer incidence and growing adoption of precision medicine approaches. C-Ray’s regulatory achievement supports this growth by providing essential infrastructure for Copper-64 based therapeutic development.

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Frequently Asked Questions

What does FDA acceptance of the Drug Master File mean for patients?

FDA acceptance enables faster development of Copper-64 based treatments by streamlining regulatory submissions, potentially bringing new radiopharmaceutical therapies to patients sooner.

When will Copper-64 treatments be available to patients?

The DMF acceptance is a regulatory infrastructure step. Individual Copper-64 based treatments still require separate clinical trials and FDA approvals, with timelines varying by specific therapy.

How does Copper-64 compare to other radioisotopes?

Copper-64’s 12.7-hour half-life and dual decay pathways make it suitable for both imaging and therapy applications, offering advantages for theranostic approaches compared to single-purpose radioisotopes.