GenFleet Therapeutics’ GFH375-Cetuximab Regimen Advances to China’s Proposed Breakthrough Therapy List

Bulletin Express09-22

GenFleet Therapeutics (Shanghai) Inc. reported that its combination regimen of GFH375 with cetuximab has been placed on the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration proposed Breakthrough Therapy Designation (BTD) list as of 18 September 2026.

The proposed BTD covers the treatment of metastatic colorectal cancer with KRAS G12D mutation in patients whose disease progressed after oxaliplatin-, fluoropyrimidine-, and irinotecan-based chemotherapy. GenFleet submitted the BTD application on 13 August 2026; the CDE’s public comment period runs until 24 September 2026, after which a final decision will be made.

Management highlighted that the programme still faces the risk of not securing BTD status. Given recent share-price strength, the board stated it is unaware of any other material factors driving the movement and confirmed that no undisclosed inside information exists.

In line with market practice, the company does not plan to issue a separate announcement upon formal inclusion of the regimen on the BTD list. Shareholders and potential investors are advised to exercise caution when dealing in GenFleet securities.

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