Curium’s Investigational New Drug Application Accepted by Center for Drug Evaluation in China

• Curium’s Investigational New Drug Application (IND) application for ¹⁷⁷Lu-PSMA-I&T, a therapeutic agent for patients with metastatic castration-resistant prostate cancer (mCRPC), has been accepted by the Centre for Drug Evaluation (CDE) and it is now under review

(Boston, MA – 7 January, 2026) – Curium Shanghai Pharmaceuticals Co., Ltd. (科锐霖（上海）医药有限公司), has had its Investigational New Drug (IND) Application for ¹⁷⁷Lu-PSMA-I&T, a therapeutic agent for patients with metastatic castration-resistant prostate cancer (mCRPC), accepted by the Centre for Drug Evaluation (CDE) which is now under review.

This represents a major milestone for Curium as the first innovative product progressing towards clinical development in China and reflects our ongoing commitment to introducing diagnostics and therapeutic innovation to patients with cancer.

The open-label, Randomized, Phase 3 bridging study will evaluate the efficacy and safety of ¹⁷⁷Lu-PSMA-I&T comparing with Hormone Therapy in Chinese Patients with Metastatic Castration-Resistant Prostate Cancer. Approximately 60 patients will be enrolled. The study will serve as a registrational trial in China and will leverage data from Curium’s ongoing global clinical trial.

Licardo Chan, General Manager NASIA, Curium International says, “Conducting these registrational trials marks a significant milestone in our mission to expand access to radiopharmaceuticals to patients with prostate cancer across China.  It is a great start to building a solid platform for the development of our future pipeline of diagnostic and therapeutic radiopharmaceuticals in collaboration with clinical experts, research institutions, and regulators, and demonstrates our confidence in China as a key market for future growth”.

This important step reinforces the strategic importance of the Chinese market and Curium’s long-term commitment to supporting its healthcare ecosystem.  Curium’s local footprint in China will enhance Curium group’s ability to serve patients with cancer and improve access to life-enhancing diagnostic and therapeutic radiopharmaceuticals.