On September 2nd, the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China announced that the new class 1 drug Belzutifan tablets declared by Merck & Co. (MSD) obtained the implied license for clinical trials and plans to be developed for renal cell carcinoma (RCC). Public information shows that the signaling pathway targeted by Belzutifan (MK-6482) is related to hypoxia-inducible factor (HIF-2α). Research on this pathway has won the Nobel Prize in Physiology or Medicine in 2019. At the same time, it is also the first hypoxia-inducible factor inhibitor approved by the FDA.
Belzutifan is an investigational, new, potent, and selective oral HIF-2α inhibitor. It is currently being evaluated in multiple clinical studies for the treatment of Von Hippel-Lindau (VHL)-related renal cell carcinoma, advanced renal cell carcinoma, and Patients with advanced solid tumors, etc. Inactivation of VHL (a tumor suppressor protein) protein can abnormally activate HIF-2α protein in cancer patients. HIF-2α factors can accumulate in patients and lead to the formation of benign and malignant tumors.
