C-RAY Sets New Record with Batch Capacity Exceeding 2 Ci
64Cu
C-RAY has recently made a significant breakthrough in medical isotope preparation. By leveraging its self-developed isotope production technology and customized fully automated facilities, the company has achieved large-scale production of 64Cu with batch yields exceeding 2 Ci （EOB）.
In accordance with China’s Three-Year Action Plan for High-Quality Development of the Nuclear Technology Application Industry (2024–2026), jointly issued by the National Atomic Energy Agency and 11 other departments, proactive R&D efforts on promising medical isotopes such as 64Cu are mandated. However, the domestic supply shortage of 64Cu has severely hindered the development and clinical translation of 64Cu-labeled drugs in China.。
C-RAY has overcome key technical challenges in 64Cu production through its proprietary proton accelerator-based synthesis process and a customized fully automated production system. The standardized, high-volume manufacturing process, supported by a rigorous quality control system, delivers 64Cu that surpasses both IAEA and industry standards. This milestone strengthens China's self-sufficient supply chain for critical medical isotopes.
Recognized by the IAEA as an 'emerging PET isotope,' 64Cu (T1/2 = 12.7 h) offers superior imaging resolution, extended scanning windows, and centralized supply capabilities compared to conventional PET isotopes like 18F (T1/2 = 110 min) and 68Ga (T1/2 = 68 min). 64Cu-labeled drugs are widely used in research and diagnostics for neuroendocrine tumors, hypoxic tumor tissues, prostate cancer, and more.
Since achieving autonomous 64Cu production, C-RAY has conducted extensive research on 64Cu-labeled small molecules, peptides, and antibodies. The company has accumulated deep expertise in nuclide synthesis, radiolabeling, non-clinical evaluation, and IIT validation.
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Radiolabeling
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Nanobodies Radiolabeled with 64Cu Under Mild Conditions Achieve 99% Radiochemical Purity
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Non-clinical Evaluation
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64Cu-Labeled Nanobodies Demonstrate Excellent Tumor Targeting with High Uptake and Prolonged Retention at Lesion Sites
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IIT
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64Cu-Labeled Molecules Validated in 100+ Human Subjects via Investigator-Initiated Trials
Both Primary and Metastatic Lesions Exhibit High Radioactive Uptake, with Biodistribution Imaging Aligning with Expected Metabolic Patterns. These Findings Hold Significant Clinical Value for PC Patient Screening, Preoperative Staging, and Recurrence Monitoring.
These findings demonstrate that 64Cu-labeled drugs enable high-resolution PET imaging with excellent detection rates and favorable safety profiles. The isotope’s longer half-life facilitates medium-to-long-distance transportation, reducing reliance on local radiopharmacies typically required for short-lived isotopes and streamlining clinical deployment.
C-RAY has established a robust 64Cu production and logistics network, operating a centralized manufacturing hub in Chengdu that delivers isotopes to 90% of Chinese cities within 24–48 hours, with APAC-wide coverage capabilities. This reliable supply chain accelerates domestic R&D progress in 64Cu-labeled pharmaceuticals.
C-RAY will launch an open CRDMO (Contract Research, Development & Manufacturing Organization) platform, leveraging its cGMP-compliant radiopharmaceutical facilities and advanced R&D infrastructure to drive collaborative innovation. The platform offers end-to-end services spanning nuclide synthesis, radiolabeling, non-clinical studies, quality control, clinical sample manufacturing, and commercial supply.
