Development of ⁶⁸Ga-NRT6020 injection and ¹⁷⁷Lu-NRT6020 injection by Chengdu New Radiomedicine Technology Co., Ltd. (“NRT”) has achieved a milestone, as the Investigational New Drug (IND) applications were approved by the U.S. Food and Drug Administration (FDA). The two injections are intended for the diagnosis and treatment, respectively, of adult patients with advanced solid tumors that positively express Fibroblast Activation Protein (FAP).

⁶⁸Ga-NRT6020 injection and ¹⁷⁷Lu-NRT6020 injection are radioligand therapies (RLT), a method of using radioactive conjugates on molecules that specifically bind to tumors, enabling precise targeting and killing of cancer cells. The two injections can specifically bind to FAP, to diagnose and treat advanced solid tumors with positive FAP expression. FAP is a pan-cancer target, mainly expressed on cancer-associated fibroblasts (CAF) with little or no expression in normal tissues. FAP has high expression levels in many types of cancer, including pancreatic cancer, breast cancer, followed by colorectal cancer, CUP (cancer of unknown primary), non-small-cell lung cancer, bladder cancer and mesothelioma, etc.

As NRT’s first RLT drug submitted for clinical trial in China and the US, the IND approval by FDA is of great significance to the company, demonstrating NRT’s R&D capabilities for RLT and also an important step of the company’s future expansion into international market. NRT will continue to work on radiopharmaceutical innovation through its RLT pipeline and technology platforms.