HK Stock Market Move | GENFLEET-B(02595) rose over 7% in morning trading; the combination therapy of GFH375 and cetuximab is proposed for inclusion in the breakthrough therapy designation list.

GENFLEET-B(02595) rose over 7% in morning trading, up 7.45% as of press time, at HK$30.58, with a turnover of HK$9.0276 million. On the news front, GENFLEET-B issued an announcement 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 in combination 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 clinical project was applied for on August 13, 2026, and the publicity deadline is September 24, 2026. The company originally planned, in accordance with market practice, to make an announcement after the clinical project was officially included in the BTD list. However, in accordance with the relevant provisions of the Listing Rules, it is specifically making an announcement at this stage regarding the review progress of the proposed inclusion in the BTD list. After the publicity of the clinical project, there remains a potential risk that approval may not be obtained. 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 view of the explanation in this announcement, the company plans not to proactively make a separate announcement after the clinical project is officially included in the BTD list.