Curium Receives Chinese Regulatory Approval to Begin Phase 3 Trial of 177Lu-PSMA-I&T for Metastatic Prostate Cancer
核心洞察
China's Centre for Drug Evaluation (搜索) has accepted Curium's Investigational New Drug application for 177Lu-PSMA-I&T, a radiopharmaceutical targeting metastatic castration-resistant prostate cancer (搜索).
The company will conduct an open-label, randomized Phase 3 bridging study comparing 177Lu-PSMA-I&T with hormone therapy in approximately 60 Chinese patients.
This marks Curium's first innovative product advancing to clinical development in China and represents a significant expansion of radiopharmaceutical access for prostate cancer (搜索) patients.
Curium Shanghai Pharmaceuticals Co., Ltd. (搜索) has achieved a significant regulatory milestone with the acceptance of its Investigational New Drug (IND) application for 177Lu-PSMA-I&T by China's Centre for Drug Evaluation (搜索) (CDE (搜索)). The therapeutic radiopharmaceutical targets patients with metastatic castration-resistant prostate cancer (搜索) (mCRPC (搜索)) and is now under regulatory review.
This development represents Curium's first innovative product progressing toward clinical development in China, marking a strategic expansion of the company's radiopharmaceutical portfolio in the Chinese market.
Phase 3 Trial Design and Objectives
The planned study is an open-label, randomized Phase 3 bridging trial that will evaluate the efficacy and safety of 177Lu-PSMA-I&T compared with hormone therapy in Chinese patients with metastatic castration-resistant prostate cancer (搜索). The trial will enroll approximately 60 patients and serve as a registrational study in China.
The study design will leverage data from Curium's ongoing global clinical trial program, providing a pathway for potential market authorization while building upon existing clinical evidence for the radiopharmaceutical.
Strategic Market Expansion
Licardo Chan, General Manager NASIA at Curium International (搜索), emphasized the significance of this regulatory acceptance: "Conducting these registrational trials marks a significant milestone in our mission to expand access to radiopharmaceuticals (搜索) to patients with prostate cancer (搜索) 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."
The regulatory approval reinforces the strategic importance of the Chinese market for Curium's long-term growth strategy and commitment to supporting China's healthcare ecosystem.
Company Profile and Global Presence
Curium Pharma (搜索) operates as a leading global radiopharmaceutical company with proven expertise in developing, manufacturing, and supplying radiopharmaceuticals (搜索) for cancer (搜索) diagnosis and treatment. The Boston-headquartered company maintains a global footprint extending to more than 70 countries, supported by over 5,000 employees and four manufacturing sites.
The company's portfolio encompasses over 45 products that advance patient care across a wide range of cancers. Curium's local footprint in China is expected to enhance the group's ability to serve cancer (搜索) patients and improve access to diagnostic and therapeutic radiopharmaceuticals (搜索) in the region.
Radiopharmaceutical Innovation Focus
The acceptance of the 177Lu-PSMA-I&T application aligns with Curium's mission to find new and better ways to diagnose and treat cancer (搜索) through radiopharmaceutical innovation. The company's pioneering legacy in nuclear medicine serves as the foundation for its dedication to innovation and portfolio expansion in cancer therapeutics, particularly in neuroendocrine tumors (搜索) and late-stage pipeline opportunities in prostate cancer (搜索).