BARCELONA, Spain, Oct. 8, 2025 — During the 2025 Annual Congress of the European Association of Nuclear Medicine (EANM 2025), C-Ray Therapeutics (Shanghai) Co., Ltd. announced breakthrough clinical results for its novel targeted alpha therapy, 225Ac-PSMA-CY313, in treating metastatic castration-resistant prostate cancer (mCRPC). The company presented these findings in two Top Rated Oral Presentations, emphasizing the therapy’s significant potential and favorable safety profile, marking a critical milestone in targeted radiopharmaceutical development.
Science Significance
225Ac-PSMA-CY313 demonstrated robust early clinical activity in heavily pretreated mCRPC patients. In a preliminary study of 13 patients, all participants achieved reductions in prostate-specific antigen (PSA) levels, with 81.8% achieving a PSA50 response (≥50% decline) and an objective response rate (ORR) of 60% among evaluable patients. Most adverse events were mild to moderate, with xerostomia (dry mouth) reported in 84.6% of patients, primarily grade 1. In addition to efficacy, C-Ray Shanghai successfully advanced dosimetry research for alpha-emitting radiopharmaceuticals, using SPECT/CT imaging to quantify internal radiation doses. Results showed high absorbed doses in tumors while keeping kidneys, liver, and other critical organs within safe exposure limits, highlighting a favorable therapeutic window and paving the way for precise, personalized treatment strategies. These findings underscore 225Ac-PSMA-CY313 as a next-generation therapeutic candidate, addressing the urgent need for effective options in mCRPC patients resistant to standard therapies.
Regulatory Significance
The early clinical results provide strong support for regulatory engagement and potential accelerated development pathways. By demonstrating both safety and efficacy in a heavily pretreated population, C-Ray Shanghai positions 225Ac-PSMA-CY313 for expedited review in multiple jurisdictions, including the United States, European Union, and Asia. Importantly, the dosimetry validation using SPECT/CT provides regulators with quantitative evidence of safety and organ-specific radiation exposure, a critical requirement for alpha-emitter therapies. This data could facilitate discussions on investigational new drug (IND) filings, clinical trial design, and eventual market approval.
Business Significance
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The clinical milestone enhances C-Ray Therapeutics’ strategic position in the competitive field of targeted alpha therapies. By generating robust early human data, the company demonstrates its capability to translate preclinical radiopharmaceutical research into clinically meaningful outcomes. C-Ray Shanghai’s integrated model, leveraging C-Ray Chengdu’s CRDMO capabilities in radiochemistry process development, preclinical evaluation, and commercial-scale manufacturing, positions the company for efficient scale-up and global commercialization. This approach not only accelerates development timelines but also reduces operational risks, making C-Ray an attractive partner for collaborations or licensing deals. The presentations at EANM 2025 are expected to catalyze partnerships with global pharmaceutical companies, further strengthening its financial and operational outlook.
Patients’ Significance
For patients with metastatic castration-resistant prostate cancer, therapeutic options remain limited, particularly after resistance to standard therapies. 225Ac-PSMA-CY313 shows potential to deliver meaningful clinical benefit, including tumor shrinkage and significant PSA reductions, while maintaining a manageable safety profile. The therapy’s targeted approach minimizes off-target radiation exposure, reducing the likelihood of severe adverse events and improving patients’ quality of life. Early responders in the trial experienced substantial reductions in tumor burden, signaling a potential new standard of care for this hard-to-treat population.
Policy Significance
The successful clinical translation of 225Ac-PSMA-CY313 reinforces the importance of targeted alpha therapies in global cancer treatment strategies. These results could influence regulatory frameworks, reimbursement policies, and government support for alpha-emitter research, potentially accelerating adoption and funding for similar therapies worldwide. By showcasing a quantitative, patient-centric approach to dosimetry and safety, C-Ray Shanghai sets a precedent for rigorous clinical standards in emerging radiopharmaceuticals, aligning with international guidelines and promoting broader acceptance of advanced nuclear medicine therapies.
Transaction Highlights
C-Ray Shanghai has established a vertically integrated model that combines early-stage discovery, clinical development, and proprietary conjugation technology. This model is reinforced through its affiliated company, C-Ray Chengdu, which provides specialized CRDMO services including radiochemistry process development, preclinical evaluation, IND-enabling support, and commercial-scale manufacturing with secure logistics. By consolidating these capabilities, C-Ray ensures a seamless translation from laboratory research to clinical and commercial deployment. The recent clinical milestones with 225Ac-PSMA-CY313 demonstrate both scientific and commercial viability, creating multiple avenues for growth. These include potential strategic collaborations, licensing agreements, and co-development partnerships with global pharmaceutical companies, as well as opportunities to accelerate market access. This integrated approach not only strengthens C-Ray’s operational efficiency and intellectual property position but also enhances its attractiveness to investors and partners looking to enter the emerging targeted alpha therapy market. Overall, the combination of innovative technology, clinical validation, and strategic operational infrastructure positions C-Ray Shanghai for sustainable growth and global expansion in the radiopharmaceutical sector.
Source: C Ray Therapeutics Press Release
