Significant Milestone Achieved in Cancer Treatment with First Patient Dosed in Phase III Trial

Milestone in Cancer Treatment: Phase III Trial Begins

On August 22, 2025, Mednovo Group Co., Ltd. announced a significant leap in the realm of cancer treatment: the first patient has been dosed in the Phase III clinical trial of Lutetium [177Lu] Oxodotreotide Injection. This targeted radiotherapeutic drug represents a beacon of hope for individuals suffering from gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

C-Ray Therapeutics, serving as the exclusive clinical supply and manufacturing partner, played a crucial role in advancing the trial. The company provided comprehensive end-to-end support, which included everything from technology transfer and clinical batch production to quality release and logistics. Utilizing China's first automated radiopharmaceutical production line, compliant with global cGMP standards, C-Ray ensured the timely launch of the trial, following their philosophy of high quality, cost efficiency, and first-time-right production.

The Importance of Lutetium [177Lu] Oxodotreotide Injection

Lutetium [177Lu] Oxodotreotide Injection is specifically designed to target somatostatin receptors, which are primarily found in neuroendocrine tumors. The initiation of Phase III trials is a significant progression for this project, as it often signifies the final stages before a potential market release. The rigorous production processes and quality controls demanded at this stage closely resemble those of commercial production.

C-Ray's adherence to cGMP standards ensures that the clinical supply meets the necessary reliability and quality, vital for trial success. Since receiving approval from China's Center for Drug Evaluation (CDE), C-Ray has efficiently coordinated with Mednovo to synchronize their clinical schedules, ensuring all raw materials were released on time, as well as completing technology transfer and production processes, thereby facilitating the prompt dosing of the first participant.

Looking Ahead: A Continued Partnership

As the multi-center trial progresses, C-Ray will maintain their support for Mednovo, utilizing patented cold-chain packaging designed specifically for radiopharmaceuticals, alongside an integrated logistics network that covers both land and air. These measures are instrumental in ensuring that the clinical supply chain remains robust and efficient.

Mednovo's representatives have expressed gratitude for C-Ray's partnership, emphasizing the crucial role they play in the overall success of the Lutetium [177Lu] Oxodotreotide Injection program. With their expert knowledge and cGMP-compliant production capabilities, C-Ray has ensured a stable supply of high-quality clinical materials, helping propel the project forward.

C-Ray's Legacy in Radiopharmaceuticals

C-Ray Therapeutics has established itself as a frontrunner in the field of radiopharmaceuticals. Since its inception, the company has successfully handled over 50 CRDMO projects, rounding the full lifecycle from early-stage research and development to clinical and commercial supply. With a sprawling cGMP-compliant R&D and manufacturing base, C-Ray aims to maintain its position as an industry leader by innovating and collaborating within the radiopharmaceutical space.

In addition, their role in developing a global radionuclide supply chain, particularly with scarce isotopes like Actinium-225, reflects their commitment to pioneering advancements in medical treatment.

The Future of Mednovo

Established on January 1, 2011, Mednovo is a diversified group focusing on healthcare, integrating various aspects of R&D, production, sales, and investment financing. Their strategic approach includes a mix of in-house R&D, acquisitions, and equity investments, enhancing their portfolio with innovative medical devices and projects.

With 39 medical device registration certificates, Mednovo is advancing its capabilities in nuclear medicine, exemplified by the ongoing evaluation of Lutetium [177Lu] Oxodotreotide Injection. This marks a dual-driven strategy focusing on both medical devices and nuclear medicine, promising greater advancements in patient care.

This teamwork not only signals a new chapter for cancer treatment but also enriches the partnership between innovative companies like C-Ray and Mednovo, promising to improve outcomes for patients in need.