Genfleet-B (02595) climbed more than 9% during Tuesday's trading session before paring gains, with shares last up 5.97% at HK$30.16 on turnover of HK$55.07 million.
The company issued an announcement stating that its board of directors has noted the recent rise in its share price and took the opportunity to update shareholders and potential investors on the latest business developments within the group.
The clinical program involving GFH375 in combination with cetuximab was included on September 18, 2026, in the Center for Drug Evaluation's preliminary list for breakthrough therapy designation under the National Medical Products Administration. The therapy targets patients with KRAS G12D-mutant metastatic colorectal cancer who have previously failed chemotherapy regimens based on oxaliplatin, fluoropyrimidines, and irinotecan.
The application for this clinical program was submitted on August 13, 2026, with the public comment period slated to conclude on September 24, 2026. The company had originally planned, in line with market convention, to announce the designation only after the clinical program was formally added to the BTD list. However, in accordance with relevant provisions of the Listing Rules, the company is now disclosing the review progress regarding the preliminary inclusion of this program in the BTD list.
There remains a potential risk that the clinical program may not receive final approval following the public comment period, and the company advises shareholders and potential investors to exercise caution when trading or considering trading in the company's securities. In light of this announcement, the company plans not to issue a separate proactive announcement once the clinical program is formally added to the BTD list.
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