GENFLEET-B (02595): The share price has risen recently; the clinical project of GFH375 combined with cetuximab combination therapy is proposed to be included in the breakthrough therapy designation list.
GenFleet Therapeutics-B (02595) announced that the board of directors has noted the recent increase in the price of the company's shares and wishes to inform shareholders and potential investors of the latest business developments of the group. The company's clinical project, GFH375 combined with cetuximab combination therapy, was proposed by the Center for Drug Evaluation of the National Medical Products Administration on September 18, 2026, to be included in the breakthrough therapy designation (BTD) list, for the treatment of KRAS G12D mutant metastatic colorectal cancer that has failed prior chemotherapy based on oxaliplatin, fluoropyrimidines, and irinotecan. The application for this clinical project was submitted on August 13, 2026, and the public notice deadline is September 24, 2026.
GENFLEET-B (02595) announces that the Board of Directors of the Company has noted the recent increase in the price of the Company's shares and wishes to inform shareholders and potential investors of the latest business developments of the Group. The Company's clinical project, GFH375 combined with cetuximab combination therapy, was proposed by the Center for Drug Evaluation of the National Medical Products Administration on September 18, 2026, to be included in the Breakthrough Therapy Designation (BTD) list for the treatment of KRAS G12D mutant metastatic colorectal cancer that has failed prior chemotherapy based on oxaliplatin, fluoropyrimidines, and irinotecan. The application for this clinical project was submitted on August 13, 2026, and the public notice deadline is September 24, 2026.
The Company had originally planned, in accordance with market practice, to make an announcement after the clinical project was officially included in the BTD list. However, pursuant to the relevant provisions of the Listing Rules, the Company is making this announcement at this stage regarding the review progress of the proposed inclusion in the BTD list. There remains a potential risk that the clinical project may not be approved after the public notice. Shareholders and potential investors of the Company are advised to exercise caution when dealing in or contemplating dealing in the securities of the Company. In light of the explanation in this announcement, the Company does not plan to make a separate announcement on its own initiative after the clinical project is officially included in the BTD list.
Having made reasonable enquiries in the circumstances, the Board confirms that, as at the date of this announcement, save as disclosed in this announcement, the Board is not aware of any reason for the increase in the share price, nor is it aware of any inside information that is required to be disclosed under Part XIVA of the Securities and Futures Ordinance (Chapter 571 of the Laws of Hong Kong).
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