GENFLEET-B(02595): GFH375 single drug research selected for oral presentation at the 2026 ASCO Annual Meeting.

GENFLEET-B(02595) announces the updated data of the single-agent therapy GFH375 for the treatment of KRAS G12D mutant solid tumors, which will be presented in oral reports at this year's ASCO (American Society of Clinical Oncology) annual meeting on June 1st local time. The report demonstrates the preliminary efficacy of GFH375 single-agent therapy in cholangiocarcinoma (CCA) and colorectal cancer (CRC). In 20 treated patients with KRAS G12D mutation cholangiocarcinoma, after at least one treatment, tumor evaluation showed an overall objective response rate (ORR) of 40% and disease control rate (DCR) of 95% across all dose levels; among the 18 patients at the 600 mg QD (RP2D) dose level, ORR was 44.4% and DCR was 94.4%. In addition, the median progression-free survival (mPFS) for all dose levels was 6.2 months. Furthermore, in 41 advanced colorectal cancer patients, the mPFS was 4.1 months and the median overall survival (mOS) was 10.3 months, preliminary data showing the single-agent activity and combination prospects of GFH375 in colorectal cancer. Currently, a phase Ib/II trial of GFH375 in combination with cetuximab for the treatment of solid tumors including colorectal cancer is ongoing domestically, with combination therapy data planned to be announced at future international academic conferences. Dr. Wan Yubo, Chief Medical Officer of GenFleet, stated: "This marks the fourth consecutive time that the clinical study results of GFH375 have been selected for oral presentations at authoritative international academic conferences, including ASCO, ESMO, WCLC annual meetings. The treatment of metastatic pancreatic cancer with GFH375 has entered the world's first phase III trial of an oral KRAS G12D inhibitor, and has also been the first to receive breakthrough therapy designation for single-agent treatment of KRAS G12D mutant pancreatic cancer and non-small cell lung cancer domestically. We are pleased to see the encouraging treatment potential of GFH375 in other tumor types and look forward to positive progress in more clinical trials of single-agent and combination therapies."