During the 2025 Annual Congress of the European Association of Nuclear Medicine (EANM 2025), C-Ray Therapeutics (Shanghai) Co., Ltd. (“C-Ray Shanghai”), a company dedicated to the development of innovative targeted radiopharmaceuticals, announced promising new clinical results for its lead program 225Ac-PSMA-CY313 in the treatment of metastatic castration-resistant prostate cancer (mCRPC).
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These data, highlighted in two Top Rated Oral Presentations, provide early clinical evidence of the therapy's significant potential and favorable safety profile, marking an important milestone for C-Ray in the field of targeted alpha therapies. Both presentations were delivered by the company's Chief Medical Officer.
One presentation, entitled “Feasibility study of 225Ac-PSMA-CY313 dosimetry in mCRPC patients using SPECT”, showcased the company's progress in dosimetry research with 225Ac. The study successfully established and validated a quantitative dosimetry approach using SPECT/CT to evaluate internal radiation doses in patients treated with 225Ac-PSMA-CY313. Findings demonstrated that tumors (particularly soft tissue lesions) received high absorbed doses, while key organs such as the kidneys and liver remained within safe exposure limits-supporting a favorable therapeutic window. Importantly, no severe adverse events (SAEs) or grade ≥3 toxicities were observed during treatment.
The second presentation, “Evaluation of the safety and efficacy of 225Ac-PSMA-CY313 in metastatic castration-resistant prostate cancer: preliminary results”, reported clinical outcomes from 13 patients treated with 225Ac-PSMA-CY313. The study results showed encouraging efficacy and manageable safety in heavily pretreated, standard therapy-resistant mCRPC patients. All patients (100%) achieved reductions in prostate-specific antigen (PSA) levels, with 81.8% achieving PSA50 response (≥50% decline). Among evaluable patients, the objective response rate (ORR) reached 60%. Most adverse events were grade 1-2, with the most common being xerostomia (dry mouth) reported in 11 of 13 patients (84.6%), including 10 grade 1 and 1 grade 2 events (per CTCAE v5.0 criteria).
“Presenting these results on such a globally recognized stage as EANM represents a significant milestone for C-Ray,” said the Chief Medical Officer of C-Ray Shanghai. “There are only a few teams worldwide that have successfully advanced an alpha-emitting radiopharmaceutical into clinical development. Not only have we developed 225Ac-PSMA-CY313, but we have also generated robust early clinical data from more than a dozen patients. This underscores our strong capabilities and commitment in both radiopharmaceutical R&D and clinical translation.”
About C-Ray Therapeutics (Shanghai) Co., Ltd.
C-Ray Therapeutics (Shanghai) is a biotechnology company focused on the discovery and development of innovative targeted radiopharmaceuticals. Based in Shanghai, the company is advancing its pipeline from early-stage discovery through clinical development, while building proprietary conjugation and linker platforms. C-Ray actively seeks global partnerships to accelerate innovation in ligands, linkers, and conjugation technologies.
To ensure seamless translation from early research through clinical development, C-Ray Shanghai works closely with its affiliated company, C-Ray Therapeutics (Chengdu) Co., Ltd. This strategic collaboration leverages C-Ray Chengdu's specialized CRDMO services, covering radiochemistry process development, quality research, preclinical evaluation, IND-enabling support, clinical supply, and commercial-scale manufacturing with secure logistics. This integrated model allows C-Ray Shanghai to remain focused on innovation and the expansion of its core competencies.
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