Peking Union Medical College Hospital Leads Approval of Globally First-in-Class Radioactive Innovative Drug

Background

Nuclear medicine employs radioactive tracers to diagnose and monitor diseases including cancer by visualizing biological processes. SPECT imaging technology is characterized by relatively simple drug preparation, lower costs compared to some alternatives and high availability of equipment in many medical facilities. However, for decades it faced limitations in tumor diagnosis, staging and treatment monitoring due to a lack of effective broad-spectrum tumor imaging agents comparable to 18F-FDG used in PET imaging.

A Peking University research team led by Professor Wang Fan developed 99mTc-3PRGD2 targeting integrin αvβ3, which is highly expressed on many tumor cells and newly formed tumor blood vessels. Peking Union Medical College Hospital's Nuclear Medicine Department led the Phases I-III clinical trials of this agent as part of efforts to provide new options in this field. The development process spanned approximately 20 years according to reports from involved institutions.

What was achieved

On April 2, 2026, China's National Medical Products Administration approved the marketing of the domestically developed radiopharmaceutical 99mTc-3PRGD2 injection and its associated preparation kit. This is reported as China's first Class 1 innovative radiopharmaceutical and the world's first approved drug specifically targeting integrin αvβ3. It is positioned as a first-in-class SPECT imaging agent capable of providing broad-spectrum tumor imaging support.

The Nuclear Medicine Department of Peking Union Medical College Hospital served as the lead institution for the multicenter Phases I-III clinical trials. Dr. Zhu Zhaohui, chief physician in the department and deputy director of the comprehensive office at the hospital's Clinical Research Institute, acted as the national principal investigator. The trials enrolled 409 participants across 11 tertiary hospitals in China. Trial results indicated that while 99mTc-3PRGD2 SPECT/CT showed no statistical difference from 18F-FDG PET/CT in differentiating benign and malignant pulmonary lesions, it demonstrated significantly higher specificity and accuracy in the evaluation of lymph node metastasis in lung cancer patients. It was reported to correct 59% of false-positive lymph node metastasis results observed with 18F-FDG PET/CT imaging. The approval provides a new auxiliary diagnostic option for lymph node metastasis in lung cancer.

How it works

The diagnostic process begins with intravenous injection of the 99mTc-3PRGD2 tracer. This compound is engineered to bind to integrin αvβ3 molecules that are overexpressed on the surface of certain tumor cells and the endothelial cells lining the new blood vessels that tumors develop to sustain growth. After binding, the technetium-99m radioisotope component emits gamma rays.

These emissions are captured by a SPECT/CT scanner from multiple angles. Computers reconstruct the data into images that highlight areas of tracer accumulation, revealing potential tumor locations and lymph node involvement. The CT component supplies detailed anatomical references, combining functional and structural information. This approach is described as addressing previous limitations in SPECT tumor imaging by offering a targeted tracer that can be prepared on-site using a generator, potentially allowing wider use in facilities equipped with SPECT rather than the more specialized and costly PET systems.

What it means for international patients

The approval introduces an additional diagnostic tool developed and clinically tested in China that may be of interest to patients seeking cancer staging options, particularly for lung cancer lymph node assessment. International patients can access care at facilities with established services for overseas visitors.

Peking Union Medical College Hospital maintains an International Medical Services (IMS) department on its Dongdan campus dedicated to international patients. Hospital information states that this service has received patients from more than 200 countries and regions. It provides English-language services throughout the care pathway, dedicated outpatient clinics, 24-hour emergency services, inpatient wards with private and suite-style rooms, and arrangements for direct billing with international commercial insurers. The department utilizes a multidisciplinary model drawing on the hospital's clinical resources. Patients should contact the hospital's International Medical Services directly to confirm current availability of this newly approved diagnostic agent, determine personal eligibility based on medical history, and obtain details on its use, as implementation of new approvals occurs according to clinical protocols and individual assessment.

About the hospital

Peking Union Medical College Hospital, also referred to as the hospital of the Chinese Academy of Medical Sciences, is located in Beijing. It operates across campuses including Dongdan and Xidan and functions as a comprehensive tertiary medical institution affiliated with the Chinese Academy of Medical Sciences and Peking Union Medical College. The hospital is involved in clinical care, research and medical education.

It maintains a specialized International Medical Services unit that offers care in English along with other languages including Japanese, French, Korean, Russian and German. The unit features independent outpatient, emergency and inpatient facilities and has served individuals from more than 200 countries and regions. The hospital's Nuclear Medicine Department led the clinical trials for the approved radiopharmaceutical, reflecting its involvement in multicenter innovative drug research. Official reports highlight its role as a center contributing to advancements in areas such as nuclear medicine.