C-RAY Therapeutics’ Innovation Breakthrough: China’s First NNSA-Approved Class II Radiopharmaceutical Transport Container Design
Radioactive Material Transport Container Registration
Type 1 and Type 2 Radioactive Material Transport Containers Successfully Obtain NNSA Registration
Recently, the TRSWRQ001 and TRSWRQ002 radioactive material transport containers, independently developed by C-Ray Therapeutics (Chengdu), successfully received design registration approval from the National Nuclear Safety Administration (NNSA) (Registration Nos.: 202Y-003 and 004). This achievement makes C-Ray the first and currently the only company in China to obtain design registration for Class II transport containers for radiopharmaceuticals. This major breakthrough not only highlights C-Ray’s strong technical expertise in the radiopharmaceutical field, but also delivers compliant, safe, and reliable integrated logistics solutions — setting a new standard for the transportation of radiopharmaceuticals.
C-Ray Therapeutics has always upheld the highest standards of corporate responsibility, strictly complying with the Regulations for the Safe Transport of Radioactive Material (GB11806), the IAEA Safety Standards SSR-6, and the International Air Transport Association (IATA) Dangerous Goods Regulations in the design and validation of its containers. The two newly registered Type A packages have successfully passed a series of rigorous tests, including assessments under normal transport conditions, additional tests for liquid radioactive materials, and specific requirements for air transport. This comprehensive validation covers multiple transportation modes — road, rail, and air — ensuring the highest level of safety and reliability throughout the entire logistics process.
The registered transport containers feature a proprietary multi-layer protective design developed in-house by C-Ray Therapeutics. By incorporating patented composite materials and advanced cushioning technology, the containers combine safety with lightweight design and exceptional reliability. They are designed to meet the transport needs of eight widely used medical radionuclides — including Ac-225, Lu-177, Ra-223, Cu-64, Zr-89, and I-131 — supporting the safe delivery of both diagnostic and therapeutic radiopharmaceuticals.
With this achievement, C-Ray Therapeutics has completed the final milestone in establishing fully compliant management of radiopharmaceutical logistics. The company is now fully compliant with all legal and regulatory requirements set by authorities including the Ministry of Ecology and Environment, the Ministry of Public Security, the Ministry of Transport, and the Civil Aviation Administration of China, covering road transport, air transport, and certifications for radioactive material transport containers.
This series of containers offers an integrated solution that meets medical cold chain requirements at both 2–8°C and 15–25°C for durations of 72 to 120 hours, providing end-to-end temperature control for radiopharmaceuticals from production through clinical application. Leveraging its own road transport licenses in combination with air transport capabilities, the company has built a highly efficient and cost-effective distribution network. This system enables delivery within 24 hours to most provincial capitals and major developed cities in China, and within 48 hours to more than 90% of prefecture-level cities, significantly enhancing the timeliness and accessibility of radiopharmaceuticals while effectively solving the “last-mile” delivery challenge.
This cold chain transportation system has already been successfully applied in clinical trial programs for radiopharmaceuticals by several leading pharmaceutical companies. It enables efficient, stable, and multi-center distribution across regions, greatly improving the timeliness and reliability of clinical sample delivery. In doing so, it helps clients accelerate clinical progress, expand trial site coverage, and enhance the overall accessibility of radiopharmaceuticals.
As China’s radiopharmaceutical industry continues its rapid growth, demand for transportation is rising, placing greater emphasis on radiation safety. C-Ray’s successful registration not only fills a critical gap in the domestic market, but also provides a compliant, safe, and controllable transport solution for radiopharmaceuticals soon to be manufactured locally.
Looking ahead, C-Ray will continue to drive innovation in the full lifecycle management of radiopharmaceuticals, supporting the healthy and sustainable development of China’s nuclear medicine industry and contributing to the creation of a safer and more efficient nuclear medicine supply chain.
