CHENGDU, China, June 2026
C Ray Therapeutics (Chengdu) Co., Ltd. announced that it has officially obtained a Radiopharmaceutical Manufacturing License (Category C) following a successful on-site inspection conducted by experts from the Sichuan Provincial Drug Review Center and relevant regulatory authorities. The approval marks a significant milestone for the company and represents the first Category C license issued in China’s radiopharmaceutical industry following the implementation of NMPA Announcement No. 134 of 2025, which introduced stricter requirements for pharmaceutical contract manufacturing, quality management systems, accountability standards, and regulatory inspections. The achievement demonstrates regulatory confidence in C Ray Therapeutics’ manufacturing compliance framework, operational execution capabilities, and ability to ensure reliable and consistent product supply for global partners developing innovative radiopharmaceutical therapies.
Regulatory Approval Strengthens CRDMO Position
The newly granted license provides important validation of C Ray Therapeutics’ Contract Research, Development and Manufacturing Organization (CRDMO) capabilities and supports future regulatory submissions and commercialization efforts for partner programs. Radiopharmaceutical manufacturing requires highly specialized production processes due to the short half-life of radioactive isotopes, strict quality requirements, and the need for synchronized logistics and distribution. These factors create substantial challenges for manufacturing organizations and require advanced operational expertise. According to the company, its manufacturing operations are guided by a commitment to “High Quality, High Efficiency, and Right First Time” standards. The company operates a state-of-the-art facility designed and managed according to global current Good Manufacturing Practice (cGMP) requirements, supported by an experienced scientific, technical, and regulatory team.
Advanced Infrastructure Supports Global Radiopharmaceutical Development
C Ray Therapeutics has established a comprehensive radiopharmaceutical development and manufacturing platform with approximately 28,000 square meters of research and cGMP manufacturing facilities. The company holds China’s highest Class A Radiation Safety License, enabling commercial-scale operations involving more than 30 radioisotopes. Its integrated infrastructure includes process development laboratories, quality research capabilities, GLP-like preclinical facilities, animal imaging centers equipped with PET/CT technology, pathology laboratories, gamma counting systems, and biodistribution analysis platforms. These resources allow the company to support the complete development lifecycle of radiopharmaceutical products, from early-stage discovery and preclinical evaluation through clinical manufacturing and commercial supply.
Advertisement
Growing Global Presence in Radiopharmaceutical Innovation
Since its establishment, C Ray Therapeutics has raised more than $187 million in funding and successfully delivered over 100 radiopharmaceutical CRDMO projects, including 58 preclinical and molecular imaging CRO programs and 42 CDMO projects. Among these programs, several have progressed into IND-enabling studies, investigator-initiated trials, clinical supply stages, and Phase III clinical development. The company has also become a key player in securing and managing radionuclide supply chains, particularly for difficult-to-source isotopes such as Actinium-225 (Ac-225), a critical isotope used in targeted radiopharmaceutical therapies. To date, C Ray Therapeutics has supported the development of 23 Ac-225 labeled programs, reinforcing its position as a strategic global partner in the rapidly expanding radiopharmaceutical and nuclear medicine sector. The newly awarded Category C manufacturing license further strengthens the company’s ability to support pharmaceutical innovators seeking advanced manufacturing solutions for next-generation cancer therapies and precision medicine products.
Source: C Ray Therapeutics press release
