GENFLEET-B (02595.HK): GFH276 Combo Trials Cleared in China and Australia

On 4 November 2026, GENFLEET-B (02595.HK) said GFH276 combination therapies won CDE trial approval or completed TGA filing in Australia for RAS-mutant cancers.

NewTimeSpace News: On 4 November 2026, GenFleet Therapeutics (Shanghai) Inc. (stock code: 02595) announced that since the third quarter of this year, several innovative combination therapies of its oral pan-RAS inhibitor GFH276 have obtained clinical trial approval from the Center for Drug Evaluation (CDE) of China's NMPA, or completed clinical trial notification with the Therapeutic Goods Administration (TGA) of Australia.

The studies cover first-line and later-line treatment of multiple RAS-mutant tumours with large indications, with some trials already enrolling patients at multiple dose levels. The approved Phase Ib/II combinations include GFH276 with an EGFR monoclonal antibody or chemotherapy for first- or second-line treatment of RAS-mutant pancreatic cancer and advanced solid tumours in China and Australia; GFH276 with a PD-1 monoclonal antibody and/or chemotherapy for first-line RAS-mutant non-squamous non-small cell lung cancer; and GFH276 with chemotherapy (± a VEGF monoclonal antibody) or with an EGFR monoclonal antibody for second-line or later RAS-mutant metastatic colorectal cancer.

RAS is a group of proteins that are key regulators of cell signalling pathways, mainly HRAS, KRAS and NRAS, the Company noted. It also cautioned that it cannot guarantee the successful development or eventual marketing of GFH276, and advised shareholders and potential investors to exercise caution when dealing in its shares.

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