Jiangsu Hengrui Pharmaceuticals (01276): HRS-7058 capsules have been included in the list of breakthrough therapeutic products.

Jiangsu Hengrui Pharmaceuticals (01276) announced that recently, the company's HRS-7058 capsule has been included in the list of breakthrough therapeutic drugs by the National Medical Products Administration's Drug Evaluation Center. It is reported that HRS-7058 is a novel, highly effective, selective small molecule covalent inhibitor intended for the treatment of late-stage solid tumors with KRAS G12C mutation. At the 2025 ESMO conference, the Phase I, multicenter, first-in-human study of HRS-7058 for late-stage solid tumors with KRAS G12C mutation was presented orally. Among the participants with solid tumors, there were 4 cases of pancreatic ductal adenocarcinoma (PDAC) who had previously failed at least one line of systemic therapy, with a confirmed objective response rate (ORR) of 75% and a disease control rate (DCR) of 100%. It showed clinically meaningful efficacy in late-stage pancreatic cancer after second-line treatment, with overall manageable safety and good tolerability. It is hoped to provide a new treatment option for patients with KRAS G12C mutant pancreatic cancer.