C Ray Expands Theranostics Platform with New Lu-177 and F-18 Production Lines
On the fast track of radiopharmaceutical R&D and production, C Ray remains steadfastly client-centric, continuously strengthening its infrastructure and radionuclide capabilities. Recently, we have achieved another capacity upgrade—with the addition of one new Lu-177 and one new F-18 production line, both scheduled for operation. This "dual-line" marks a pivotal step forward in the company's strategic development in Theranostics.
C Ray’s existing automated Lu-177 production line is dedicated to the manufacturing of clinical samples and commercial projects. With the rapid growth in the company's project portfolio, to simultaneously meet the batch requirements of clients at different stages, C Ray has added a new cGMP-grade automated production line based on the existing Lu-177 line. This new line is designed for pilot-to-commercial scale production, enabling flexible and efficient preparation from pilot-scale to commercial batches. This expansion not only completes the company's production capacity echelon but also significantly enhances its multi-tasking capability and delivery speed for Lu-177 projects, providing solid support for the rapid advancement and commercial translation of the R&D pipeline.
Upon the commissioning of the new Lu-177 production line, the company's overall Lu-177 capacity is expected to increase by approximately 80%. It will be capable of simultaneously supporting 4–5 Phase III clinical and commercial production projects, with an annual output reaching about 60,000 doses. This expansion significantly enhances the company's multi-tasking capabilities and delivery speed for Lu-177 projects.
Furthermore, the new line offers strong adaptability and is compatible with the production of non-terminally sterilized products utilizing other therapeutic radionuclides such as Ac-225 and Tb-161. This further extends the company's process platform capabilities in the field of therapeutic radionuclides.
Lu-177 Production Line
(Compatible with production of non-terminally sterilized products using α- or β-emitting radionuclides such as Ac-225 and Tb-161)
The introduction of the F-18 production line marks another strategic milestone for C Ray. As the most widely used positron-emitting radionuclide in clinical practice, F-18 is considered the "gold standard" for PET diagnostics. By enabling precise imaging for patient screening, treatment efficacy evaluation, and radiation dosimetry calculations, it serves as a critical starting point for achieving Theranostics.
The new F-18 line is expected to achieve an annual output exceeding 300 Ci, capable of meeting the daily imaging radiopharmaceutical supply demands for dozens of PET centers. Furthermore, the line is designed with strong extensibility and can be adapted for the production of other commonly used diagnostic radionuclides, such as Zr-89 and Ga-68.
The company's existing production lines already cover other key diagnostic radionuclides such as Tc-99m, In-111, and Cu-64. With this, C Ray has now established a comprehensive diagnostic radionuclide platform covering mainstream SPECT and PET imaging.
This development not only signifies a more complete spectrum of diagnostic radionuclide production capabilities for C Ray but also marks the company's official entry into a phase of systematic layout in molecular imaging and diagnostic pharmaceuticals. This integrated platform will enable clients to complete the full workflow—from imaging validation and efficacy assessment to therapeutic drug development—all within a single ecosystem, thereby accelerating the translation and regulatory filing of Theranostic agents.
F-18 Production Line
(Adaptable for production of other commonly used diagnostic radiopharmaceuticals, such as Zr-89 and Ga-68)
Thus, C Ray has established a comprehensive R&D and production system encompassing a full spectrum of diagnostic radionuclides—including F-18, Ga-68, Zr-89, Cu-64, Tc-99m, and In-111—as well as core therapeutic radionuclides such as Lu-177, Ac-225, and Tb-161.
This system fully complies with the cGMP quality standards of both NMPA and FDA, providing a solid, reliable, and compliant supply of radiopharmaceuticals to support the entire closed-loop process from diagnosis to treatment in Theranostics.
Within C Ray's integrated platform, complex and fragmented R&D and production processes are seamlessly consolidated: from CMC process development and GLP-Like non-clinical studies to clinical supply and commercial cGMP manufacturing, multi-nuclide GMP production, and reliable logistics coverage across China and overseas—all critical stages are seamlessly connected within a single site. Through centralized resource management and optimized workflows, we significantly reduce clients’ overall costs, delivering a truly efficient, high-quality, one-stop solution.
Introduction to C Ray Therapeutics
C Ray Therapeutics is dedicated to delivering end-to-end solutions for innovative radiopharmaceuticals to clients around the world. Our services span process development, quality research, preclinical evaluation, IND Enabling, clinical supply, and commercial scale cGMP production, all backed by a reliable, robust logistics network. As of 2024, we have raised over USD 187 million in total funding.
As a dedicated CRDMO partner in radiopharmaceuticals, one of our core strengths is a stable, diversified supply of radionuclides. We are actively developing high-quality domestic sources while playing a leading role in integrating and fortifying the global supply chain—most notably securing access to challenging isotopes such as Ac-225. To date, we have supported the development of 16 Ac-225–labeled projects.
Committed to empowering the industry, C Ray Therapeutics is building an open, integrated “production–academia–research–application” platform. By pooling resources across the value chain and pioneering critical radiopharmaceutical technologies, we accelerate the clinical translation of integrated diagnostic & therapeutic solutions. Our goal is to drive innovation and industrial upgrading in the radiopharmaceutical sector, establishing ourselves as a global benchmark in the field.
