The pharmaceutical company HENGRUI PHARMA (01276) has announced that its HRS-7058 capsule has been included in the Breakthrough Therapy Designation list by the Center for Drug Evaluation of the National Medical Products Administration.

HRS-7058 is described as a novel, highly effective, and selective small-molecule covalent inhibitor intended for the treatment of advanced solid tumors with a KRAS G12C mutation.

Data from a Phase I, multicenter, first-in-human study of HRS-7058 for KRAS G12C-mutated advanced solid tumors were presented as an oral report at the 2025 ESMO congress. Among enrolled participants with solid tumors, four had pancreatic ductal adenocarcinoma (PDAC) that had failed at least one prior line of systemic therapy. In this group, the confirmed objective response rate (ORR) was 75%, and the disease control rate (DCR) was 100%.

The results indicate clinically meaningful efficacy in later-line treatment for advanced pancreatic cancer, with an overall manageable safety profile and good tolerability. The therapy holds promise as a new treatment option for patients with KRAS G12C-mutated pancreatic cancer.