C-Ray Therapeutics Supports Mednovo's Phase III Clinical Trial with First Patient Dosed for Lutetium [177Lu] Oxodotreotide Injection

CHENGDU, China, Sept. 10, 2025 /PRNewswire/ -- August 22, 2025, Mednovo Group Co., Ltd. ("Mednovo") announced 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.

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.

About Mednovo

Mednovo was established on January 1, 2011, as a diversified large-scale group company integrating R&D, production, sales, and investment& financing, with a dedicated focus on the healthcare industry. Since 2021, the group has adopted a strategy of "in-house R&D + acquisitions + equity investments" to establish multiple medical device projects, diversifying its portfolio and realizing its grand technological strategic vision for the industry. 

Starting with minimally invasive interventional sales, Mednovo has built a nationwide sales and service network. The group adheres to a dual approach of independent R&D and technology introduction, initially establishing an R&D, production, and operational system with internationally advanced standards. With a deep focus on global markets, the group actively seeks cutting-edge international technologies that address unmet market needs. Through an innovative industry collaboration model of "financial investment + sales partnership," Mednovo works hand-in-hand with leading players, using investment to drive projects and projects to fuel development. 

Currently, the group holds 39 medical device registration certificates, covering multiple specialized fields such as drug-coated balloon products, microwave ablation therapy products, cryoablation therapy products, tumor interventional embolization therapy products, neurointerventional products, and assisted reproductive consumables. Additionally, the group is expanding into the nuclear medicine sector, with several innovative nuclear medicine products under development. This has formed a dual-driven development strategy of "devices + nuclear medicine," dedicated to advancing the healthcare industry through innovative technologies.

About C-Ray Therapeutics

C-Ray Therapeutics is a leading radiopharmaceutical CRDMO in China, providing one-stop solutions from process development and IND application to clinical supply and commercial manufacturing. The company operates a 28,000 m² world-class cGMP production base and GLP-like pre-clinical research facilities. To date, C-Ray has delivered more than 50 CRDMO projects, among these, 6 projects are at the IND and IND-enabling stages, 7 have advanced to investigator-initiated trials (IIT), and 2 have 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. To date, C-Ray has successfully supported the development of 14 Ac-225–based labeling programs.

Through its industry-academia-research-application platform, C-Ray aims to drive innovation, overcome technical barriers, and accelerate the clinical translation of diagnostic and therapeutic radiopharmaceutical solutions, positioning itself as a benchmark enterprise in global radiopharmaceutical development.

SOURCE C Ray Therapeutics