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 that it had 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 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 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.

"This drug is primarily used for the auxiliary diagnosis of lymph node metastasis in lung cancer patients. It is China's first independently developed Class 1 innovative radiopharmaceutical and the world's first radioactive imaging agent targeting a specific molecular marker. The approval of this drug marks an original breakthrough from 'zero to one' in China's nuclear medicine field," said Zhou Haohui, lead reviewer at Department I of the Center for Drug Evaluation of NMPA.

Before approval, clinical trials were conducted at over a dozen top-tier hospitals across the country, led by Peking Union Medical College Hospital. The results showed that the new drug demonstrated superior diagnostic specificity for lymph node metastasis in lung cancer compared to conventional PET/CT (Positron Emission Tomography/Computed Tomography) imaging, meeting development expectations.

"We completed clinical studies involving 409 participants across 11 hospitals nationwide. The results proved that the drug's specificity for diagnosing lymph node metastasis in lung cancer is significantly better than that of conventional PET/CT scans. Its higher specificity enables more precise guidance for clinical surgery," said Zhu Zhaohui, chief physician of the nuclear medicine department at Peking Union Medical College Hospital. 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 radiopharmaceutical sector is entering a period of rapid growth. China's radiopharmaceutical market is expected to reach about 26 billion yuan (about 3.6 billion) by 2030, according to consultancy Frost and Sullivan, as more pharmaceutical companies move into the sector.