China green lights domestically made radioactive imaging drug

China has approved a domestically developed radioactive imaging drug to help detect whether lung cancer has spread to lymph nodes, marking a step forward for the country's nuclear medicine industry.

The National Medical Products Administration said in a statement online on April 2 it approved technetium [99mTc] pexidotide injection and its preparation kit through a priority review process. The drug is used to assist doctors in checking regional lymph node metastasis in patients suspected of having lung cancer.

The drug, also known as 99mTc-3PRGD2, is a radioactive diagnostic agent that targets integrin αvβ3-positive tumors and is used together with SPECT/CT imaging systems. It can be used for imaging thoracic tumors, including diagnosing and evaluating primary lung tumors and metastases.

The product is China's first domestically developed Class 1 innovative nuclear medicine drug and the world's first broad-spectrum tumor imaging agent designed for SPECT imaging, according to industry information.

Experts say the approval could expand the use of SPECT imaging in tumor diagnosis, staging and treatment monitoring — areas that have long been dominated by PET imaging technology.

Nuclear medicine is an important part of precision medicine and plays a key role in diagnosing and treating major diseases such as cancer and cardiovascular conditions.

The newly approved drug binds to integrin αvβ3 receptors found on tumor cells and newly formed tumor blood vessels, allowing more precise imaging. Because SPECT equipment is more widely available and the drug is relatively easier to prepare, it could also lower examination costs and improve access to nuclear medicine diagnostics.

The radiopharmaceutical sector is entering a period of rapid growth. China's radiopharmaceutical market is expected to reach about 26 billion yuan ($3.6 billion) by 2030, according to consultancy Frost & Sullivan, as more pharmaceutical companies move into the sector.