China approves first homegrown nuclear imaging drug for tumor detection

China approved on Thursday an innovative nuclear medicine imaging agent developed by a research team led by Professor Wang Fan at Peking University. The agent is the world's first radioactive drug designed to seek out and image tumors by targeting a protein found on cancer cells and blood vessels.

It is also China's first domestically developed Class 1 nuclear medicine drug. Experts say the approval could expand the role of Single-Photon Emission Computed Tomography (SPECT) imaging in cancer diagnosis, staging, and treatment monitoring.

Molecular imaging is widely used in modern medicine to detect and evaluate diseases, particularly cancer. For decades, the PET/CT scan, developed in the United States, has been considered the clinical gold standard for detecting and staging many tumors. However, such imaging can be costly and requires complex drug preparation and specialized equipment, limiting its availability in some hospitals.

SPECT imaging systems are more widely available and less expensive to operate, but the lack of effective tumor-targeting imaging drugs has limited their use in tumor detection. The recent drug approval helps address this gap.

The agent targets a protein highly expressed on tumor cells and newly formed blood vessels that support tumor growth. Researchers say the imaging agent is relatively simple to prepare and suitable for routine clinical use.

In Phase III clinical trials, the drug performed similarly to PET/CT scans in distinguishing benign from malignant lung lesions.

Researchers say this could help improve diagnostic accuracy and guide more precise treatment decisions while making advanced imaging more accessible.

Over the past decade, Chinese nuclear medicine physicians have conducted multiple studies using the drug, publishing nearly 30 clinical research papers and developing expert consensus on its clinical use in lung, breast, esophageal, and thyroid cancer.

Experts say the approval could mark an important step in expanding the use of SPECT imaging for oncology and strengthening China's capabilities in nuclear medicine innovation.