GENFLEET-B (02595) rose more than 8% in late trading, closing up 7.46% at HK$31.1 with a turnover of HK$28.08 million. On November 11, the drug clinical trial registration platform revealed that GENFLEET initiated a multicenter, open-label, randomized controlled Phase III clinical study comparing the efficacy, safety, and tolerability of GFH375 monotherapy versus investigator-selected chemotherapy in KRAS G12D-mutated metastatic pancreatic cancer patients.
According to the company's prospectus, GFH375 is positioned as a leading oral G12D inhibitor. The monotherapy was approved for Phase I/II trials in June 2024, and GFH375/VS-7375 has already received FDA Fast Track designation this year for first-line and subsequent treatment of locally advanced or metastatic KRAS G12D-mutated PDAC patients. Earlier clinical data on GFH375 monotherapy for solid tumors were presented as late-breaking abstracts (LBA) and oral reports at major international conferences, including ASCO and WCLC.