On Jan. 6, 2023, LNC PHARMA received the IND approval from the US FDA regarding the 177Lu-LNC1004 injection for the Phase I clinical trial. 

177Lu-LNC1004 injection is a FAP-targeted radionuclide therapeutic drug, suitable for patients with Advanced FAP-Positive Solid Tumors. The targeting specificity of FAP enables the delivery of radionuclide Lu-177 to the lesion site. Lu-177 is a therapeutic nuclide with an average range of 670 μm in tissues due to its relatively low β-particle energy. It has a relatively less suppressive effect on the bone marrow, which can kill tumor cells in a safer and more effective way, to reduce side effects on the human body. Evans Blue (EB) moiety in LNC1004 can increase the tumor effective uptake, extend the treatment time window, and achieve standard or better treatment effects with a reduced amount of radioactive isotopes, thus, reduce patients’ treatment burden.

Before then, in order to cooperate with the clinical trial of this product, LNC PHARMA has received the FDA IND approval for the 68Ga-FAPI46 injection as a companion diagnostic drug, which is used for patient screening, efficacy evaluation, and collection of relevant safety information.