China has achieved a historic milestone with the approval of the world’s first self-developed radioactive innovative drug for market launch. Tailored for the auxiliary diagnosis of lymph node metastasis in lung cancer patients, this drug represents China’s first fully domestically developed Category 1 innovative radioactive pharmaceutical and the first radioactive imaging agent globally to target a specific biomarker. Its approval underscores China’s groundbreaking advancement from 0 to 1 in the realm of nuclear medicine.

In China, chemical drug registration is categorized into five classes, with Category 1 innovative drugs standing at the pinnacle of innovation. Radioactive drugs are pivotal in disease diagnosis and treatment; however, China previously faced significant gaps in the development of original nuclear medicine drugs. The approval of this novel drug disrupts the nearly three-decade-long status quo, addressing the scarcity of original targeted radioactive diagnostic agents in China’s nuclear medicine tumor imaging landscape.