On September 10, 2025 Mednovo Group Co., Ltd. ("Mednovo") reported that the first patient has been successfully dosed in its Phase III clinical trial of Lutetium [177Lu] Oxodotreotide Injection, a Class 3 targeted radiotherapeutic drug (Press release, Mednovo, SEP 10, 2025, View Source [SID1234655935]).
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As the exclusive clinical supply and manufacturing partner, C-Ray Therapeutics delivered end-to-end support for this milestone, including technology transfer, clinical batch production, quality release, and logistics. Leveraging China’s first fully automated radiopharmaceutical production line built to global cGMP standards, C-Ray ensured the trial began on schedule. The company’s philosophy—high quality, cost efficiency, and first-time-right production—underpinned its execution.
Lutetium [177Lu] Oxodotreotide Injection targets somatostatin receptors and is primarily indicated for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Entering Phase III represents a pivotal step for the program, requiring production processes and quality controls that meet near-commercial standards. C-Ray’s cGMP manufacturing capabilities and globally compliant quality system provided a solid foundation for reliable clinical supply.
Since the project was accepted by China’s Center for Drug Evaluation (CDE), C-Ray has 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.
Looking ahead, C-Ray 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.
A Mednovo representative commented that C-Ray Therapeutics is a vital partner for their Lutetium [177Lu] Oxodotreotide Injection program. Their professional expertise, efficiency, and cGMP-compliant automated production line ensured the stable, high-quality supply of clinical materials for this Phase III trial. They look forward to advancing this program together.
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. With a 28,000 m² cGMP-compliant R&D and manufacturing base and a global radionuclide supply chain, C-Ray continues to deliver high-quality, efficient, and fully compliant solutions for pharmaceutical partners worldwide.