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Drug Approval · English Editorial Summary

First-in-class radiopharmaceutical for lung cancer imaging wins approval in China

China’s drug regulator has approved technetium-99m 3PRGD2 — the country’s first domestically developed Class 1 radiopharmaceutical and the first drug worldwide approved against the integrin αvβ3 target — to help assess lymph node spread in lung cancer, after PUMCH-led phase I–III trials in 11 hospitals.

Original report: 27 April 2026English summary: 2 May 2026Source: PUMCH official websiteEdited by Wellward China
Peking Union Medical College HospitalBeijingCancer & TumorsRadiopharmaceuticalNuclear medicineLung cancerSPECT/CT
Source and editorial note: This is an original English summary based on PUMCH’s Chinese-language report, published 27 April 2026, about an approval granted 2 April 2026. It is not a full translation or an independent clinical assessment.
What was approved

A first-in-class imaging agent, not a treatment

On 2 April 2026, China’s National Medical Products Administration approved technetium-99m pexirestide-gotide (99mTc-3PRGD2) injection and its matching labelling kit. The agent is a tracer for SPECT and SPECT/CT imaging that binds integrin αvβ3 — making it, per the report, the first drug approved anywhere against that target. Its approved indication is the auxiliary diagnosis of lymph node metastasis in lung cancer, and it passed review under NMPA’s priority review pathway. The report frames the approval as China’s first self-developed radioactive Class 1 innovative drug, ending roughly three decades without an original targeted radiodiagnostic agent in domestic nuclear medicine.

What the trials reported

The clinical programme was led by PUMCH nuclear medicine physician Zhu Zhaohui across 11 tertiary hospitals.

Reported results — diagnostic performance in a specific setting

Across 409 participants in the phase I–III programme, the tracer showed significantly better specificity and accuracy than conventional 18F-FDG PET/CT for diagnosing lung cancer lymph node metastasis, according to the hospital’s report. This claim concerns one diagnostic question — nodal spread in lung cancer — and is an “auxiliary” indication, meaning it supplements rather than replaces existing imaging. It is not a comparison of SPECT/CT versus PET/CT for all cancer imaging needs.

How to read this approval

An imaging agent changes what doctors can see, not what the tumour can do: 99mTc-3PRGD2 carries no therapeutic effect. Better visualisation of nodal spread could influence surgical planning and treatment choice, but the report does not yet include data showing that using the tracer improves survival or long-term outcomes. Real-world performance, availability and pricing after approval are also not yet described.

What comes next

The hospital says it will continue supporting clinical development of independently developed innovative drugs. Broader use will depend on how quickly the agent reaches hospital pharmacies, and on its inclusion in clinical guidelines and insurance coverage — none of which the report specifies.

Relevance for patients with lung cancer

Accurate staging drives lung cancer decisions, from surgery extent to systemic therapy. A new, domestically produced imaging option may expand capacity and choice in China’s nuclear medicine departments. This falls under Wellward China’s Cancer & Tumors health area. This page is general information, not medical advice.