Mednovo Doses First Patient in Phase III Trial of Lutetium-177 Radiotherapy for Neuroendocrine Tumors
核心洞察
Mednovo Group successfully dosed the first patient in its Phase III clinical trial of Lutetium [177Lu] Oxodotreotide Injection (搜索) for gastroenteropancreatic neuroendocrine tumors (搜索) on August 22, 2025.
The targeted radiotherapeutic drug works by binding to somatostatin receptors (搜索) and represents a pivotal advancement in treating GEP-NETs (搜索) with near-commercial production standards.
C-Ray Therapeutics (搜索) served as the exclusive manufacturing partner, utilizing China's first fully automated radiopharmaceutical production line built to global cGMP standards.
Mednovo Group Co., Ltd. (搜索) announced on August 22, 2025, that the first patient has been successfully dosed in its Phase III clinical trial of Lutetium [177Lu] Oxodotreotide Injection (搜索), marking a significant milestone for this Class 3 targeted radiotherapeutic drug designed to treat gastroenteropancreatic neuroendocrine tumors (搜索) (GEP-NETs (搜索)).
The achievement represents a critical advancement in radiopharmaceutical development, with the drug targeting somatostatin receptors (搜索) to deliver precise therapeutic radiation to tumor cells. Entering Phase III represents a pivotal step for the program, requiring production processes and quality controls that meet near-commercial standards.
Manufacturing Partnership Enables Clinical Success
C-Ray Therapeutics (搜索) served as the exclusive clinical supply and manufacturing partner, delivering comprehensive end-to-end support including technology transfer, clinical batch production, quality release, and logistics. The company leveraged China's first fully automated radiopharmaceutical production line built to global cGMP standards to ensure the trial began on schedule.
Since the project was accepted by China's Center for Drug Evaluation (搜索) (CDE), C-Ray worked closely with Mednovo's clinical schedule, efficiently completing raw material release, technology transfer, production, testing, and nationwide logistics to ensure timely first-patient dosing.
A Mednovo representative commented that C-Ray Therapeutics (搜索) is a vital partner for their Lutetium [177Lu] Oxodotreotide Injection (搜索) program, noting that "their professional expertise, efficiency, and cGMP-compliant automated production line ensured the stable, high-quality supply of clinical materials for this Phase III trial."
Advanced Manufacturing Capabilities Support Complex Trial
C-Ray's cGMP manufacturing capabilities and globally compliant quality system provided a solid foundation for reliable clinical supply. The company will continue supporting Mednovo's multi-center trial with its patented, internationally compliant cold-chain packaging for radiopharmaceuticals and its integrated land-air logistics network.
The manufacturing partner operates a 28,000 m² world-class cGMP production base and GLP-like pre-clinical research facilities. To date, C-Ray has successfully supported more than 50 CRDMO (Contract Research, Development, and Manufacturing Organization) projects across the full lifecycle—from early-stage R&D to clinical and commercial supply.
Expanding Radiopharmaceutical Portfolio
Mednovo, established in 2011 as a diversified healthcare group company, currently holds 39 medical device registration certificates covering multiple specialized fields. The group is expanding into the nuclear medicine sector, with several innovative nuclear medicine products under development, forming a dual-driven development strategy of "devices + nuclear medicine."
C-Ray Therapeutics (搜索) has delivered more than 50 CRDMO projects, with 6 projects at the IND and IND-enabling stages, 7 advanced to investigator-initiated trials (IIT), and 2 entered the clinical supply phase. The company also plays an active role in developing and integrating the global radionuclide supply chain, including securing scarce isotopes such as Actinium-225 (搜索), having successfully supported the development of 14 Ac-225–based labeling programs.