GENFLEET-B (02595.HK): GFH375 Combo Proposed for BTD in Colorectal Cancer

NewTimeSpace News: On 22 September 2026, GenFleet Therapeutics (Shanghai) Inc. (stock code: 02595) announced that it had noted the recent increase in the price of its shares and informed shareholders and potential investors of the latest business updates of the Group. The Company's clinical program evaluating GFH375 combined with cetuximab was placed on the proposed Breakthrough Therapy Designation (BTD) list by the Center for Drug Evaluation of China's National Medical Products Administration on 18 September 2026, for the treatment of metastatic colorectal cancer harbouring KRAS G12D mutation in patients with disease progression following prior oxaliplatin-, fluoropyrimidine- and irinotecan-based chemotherapy. The application for BTD was submitted on 13 August 2026, and the public comment period will conclude on 24 September 2026.

The Company had originally planned to make an announcement after the formal inclusion of the clinical program into the BTD list in accordance with market practice, but in compliance with relevant terms of the Listing Rules it announced at this stage the regulatory progress related to the proposed inclusion. There remains a risk that the clinical program may not be granted BTD following the public comment period. The Board also confirmed that, save as disclosed, it is not aware of any reason for the rise in the share price nor of any inside information required to be disclosed under Part XIVA of the Securities and Futures Ordinance. Pursuant to the warning statement under Rule 18A.05 of the Listing Rules, the Company cannot guarantee that it will be able to successfully develop or ultimately market GFH375.

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