C-Ray Therapeutics Receives Radiopharmaceutical Manufacturing Authorization under China's MAH Framework

CHENGDU, China, June 25, 2026 /PRNewswire/ -- On June 23, 2026, C-Ray Therapeutics (Chengdu) Co., Ltd. ("C-Ray Therapeutics") completed on-site inspections conducted by a panel of experts from the Sichuan Provincial Center for Drug Evaluation and the National Defense Science and Industry Administration. The company has officially obtained the Radiopharmaceutical Production License.

The certification was granted under China's updated regulatory framework for outsourced pharmaceutical manufacturing, following strengthened requirements for quality management systems, responsibility allocation, and on-site inspection standards.

The approval confirms that C-Ray Therapeutics' compliance system, on-site execution capability, and reliable supply performance in radiopharmaceutical contract manufacturing meet regulatory expectations. It also strengthens the foundation for future regulatory submissions and the commercialization of partnered programs.

Radiopharmaceutical manufacturing is characterized by short production cycles, stringent quality requirements, and complex supply chain coordination. These factors place high demands on the compliance systems and operational capabilities of contract development and manufacturing organizations.

Guided by its philosophy of "high quality, high efficiency, and first-time-right execution," C-Ray Therapeutics has established a modern cGMP-compliant manufacturing facility operated by an experienced technical and regulatory team. To date, the company has delivered more than 100 CRDMO projects, covering the full development lifecycle from early-stage research to commercial supply.

About C-Ray Therapeutics

C-Ray Therapeutics is a global CRDMO providing end-to-end radiopharmaceutical development services — from target validation and preclinical evaluation to IND-enabling studies, clinical supply, and commercial-scale cGMP manufacturing. Operating from its 28,000-square-meter Chengdu facility under China's Class A Radiation Safety License, C-Ray supports 30+ radioisotopes and has delivered 100+ projects spanning diagnostic and therapeutic programs, including 5 programs at IND or IND-enabling stage, 29 have advanced to investigator-initiated trials (IITs), 7 in clinical supply, and 2 in Phase III clinical trials. For more information, visit www.c-raytherapeutics.com

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SOURCE C Ray Therapeutics