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The radiopharmaceutical industry in China is witnessing rapid expansion, supported by favorable policies, a growing clinical trial ecosystem, and continuous regulatory improvements. While not without certain limitations, China offers distinct advantages to global radiopharmaceutical companies in clinical development.
National and local governments have implemented various policies to promote nuclear medicine and radiopharmaceutical advancement. For instance, dedicated review and approval pathways for radiopharmaceuticals have been established, helping to streamline development timelines. Regional efforts, such as those in Sichuan Province, further enhance isotope supply and R&D support.
China’s substantial patient population, especially in oncology, allows for quicker and more efficient clinical trial enrollment compared to many Western countries. For example, liver cancer alone sees over 400,000 new cases annually in China, offering a broad foundation for radiopharmaceutical clinical research.
According to Moore Medicine statistics, there are currently 123 radiopharmaceutical drug candidates under clinical development in China, including 47 Phase I, 19 Phase II, and 43 Phase III trials. Oncology leads with 98 projects. Among therapeutic targets, PSMA and c-Met attract the strongest R&D focus, with 20 and 11 ongoing trials respectively, alongside other notable targets such as SSTR, FAP, and αvβ3. Industry leaders including Atomic High Tech, Beijing Xian Tong International, Jiangsu Hengrui Pharmaceuticals, and Yantai Lannacheng are driving much of this activity, with pipelines considerably larger than their peers.
While importing radiopharmaceuticals into China can involve complexity, local CDMOs offer robust support. Companies such as China Grand Pharma and C-Ray Therapeutics operate advanced, highly automated production systems capable of supplying a wide range of radioisotopes for both R&D and commercial use. This enables global sponsors to establish stable, high-quality supply chains within China.
China permits Investigator-Initiated Trials (IITs) for unapproved radiopharmaceuticals in qualified hospitals under strict quality control. For instance, investigational agents like 68Ga-PSMA can be studied in exploratory settings prior to formal IND trials. This flexible approach enables overseas companies to:
✓ Generate early clinical data rapidly and cost-effectively in Chinese patients
✓ Accelerate proof-of-concept validation for novel radiopharmaceuticals
✓ Lay the groundwork for subsequent IND submissions and global trial strategies
The IIT pathway offers an efficient, lower-risk entry into China’s clinical research landscape, making it particularly appealing for companies developing innovative radiopharmaceuticals.
By 2025, over 500 medical institutions in China are expected to be licensed for radioactive drug use, with more than 1,700 experienced investigators actively involved in radiopharmaceutical studies. This extensive network and expert investigator base provide a solid foundation for multicenter trials.
China presents global radiopharmaceutical companies with a compelling combination of strengths: strong policy support, faster patient enrollment, reliable local CDMO capabilities, a flexible IIT route, and increasingly transparent regulation. While challenges like import restrictions remain, China is establishing itself as a highly competitive and cost-efficient location for radiopharmaceutical clinical development.