China has launched its first domestically developed new drug in the nuclear medicine sector, a field essential for cancer diagnosis. Experts say the drug could significantly improve accessibility by enabling tumor diagnosis with lower-cost equipment.
China's National Medical Products Administration on Wednesday approved the commercialization of Zhiruntai (99mTc-3PRGD2), an injectable nuclear medicine drug developed by Ruidi Pharmaceutical based in Foshan, Guangdong Province, along with its related diagnostic kit, according to local media including Securities Times. Nuclear medicine is a medical field that administers trace amounts of radioactive substances into the body to diagnose or treat diseases, playing a central role in cancer diagnosis.
This marks the first time China has introduced a self-developed new drug in the nuclear medicine sector. Notably, among nuclear medicine drugs used for broad-spectrum tumor diagnosis rather than specific cancer types, it is the world's first to enable diagnosis through single-photon emission computed tomography (SPECT). SPECT accounts for 76% of the nuclear medicine equipment market and is widely available, but its low image resolution had limited its use primarily to bone and heart disease diagnosis. Cancer diagnosis has relied on positron emission tomography (PET) equipment, which costs two to three times more than SPECT in both equipment and diagnostic fees.
Zhiruntai overcomes SPECT's low-resolution limitation by binding to integrin αvβ3, a protein frequently found around cancer cells and surrounding blood vessels, to precisely pinpoint tumor locations. In clinical results, the drug showed no significant difference from PET scans in distinguishing between benign and malignant lung lesions, and demonstrated higher accuracy in diagnosing lymph node metastasis in lung cancer. It also reduced false positives by approximately 60% compared to conventional testing.
Within China, the drug is expected to contribute to making precision cancer diagnosis more accessible to the general public by lowering costs through SPECT compatibility. "This drug approval demonstrates that China has risen from a follower to a leader in the nuclear medicine field," Securities Times said.
China's nuclear medicine market is growing rapidly. According to market research firm Frost & Sullivan, the market is projected to expand at an annual average rate of 8% to 10%, reaching 26 billion yuan ($3.6 billion) by 2030. The growth is driven by continued government support amid Beijing's broader strategic competition with the United States. In 2021, seven government ministries jointly released the "Medium- to Long-Term Development Plan for Medical Isotopes (2021–2035)," the first long-term roadmap for the nuclear medicine sector. This year, biomedicine was designated as a core strategic industry at the Two Sessions, China's annual legislative meetings.