Hengrui Pharma (600276.SH) announced that its HRS-4642 injection has been included in the Breakthrough Therapy Designation list by the Center for Drug Evaluation of the National Medical Products Administration. The proposed indication is for the first-line treatment of advanced or metastatic pancreatic cancer with KRAS G12D mutation, in combination with gemcitabine and paclitaxel (albumin-bound). Pancreatic cancer is a common malignant tumor of the digestive tract. According to the latest global cancer statistics, there were 510,566 new cases of pancreatic cancer worldwide in 2022, ranking 12th among malignant tumors. The number of deaths reached 467,005, ranking 6th in cancer mortality and accounting for approximately 5% of global cancer deaths. HRS-4642 injection is a self-developed KRAS G12D inhibitor with a liposomal formulation. The product specifically binds to KRAS G12D, inhibiting the phosphorylation of MEK and ERK proteins to exert anti-tumor effects. Currently, no similar drugs have been approved for marketing globally.